Steven R. Goldstein, M.D.

Gynecologic effects of arzoxifene in postmenopausal women with osteoporosis or low bone mass
Goldstein S.R.; Bhattoa H.P.; Neven P.; Cox D.A.; Dowsett S.A.; Alam J.; Sipos A.; Muram D.
2012 ;19(1):41-47, Menopause
OBJECTIVE: The aim of this study was to report the gynecologic safety findings from the Generations trial, a phase 3 study of the selective estrogen receptor modulator (SERM), arzoxifene. METHODS: A predefined objective of the trial was to evaluate the effects of arzoxifene on the genital tract. Gynecologic examinations were performed yearly, and further gynecologic assessment, including endometrial biopsy, was performed in a predefined subset of women and in those who developed vaginal bleeding. RESULTS: Overall, 9,354 women were randomized (4,678 to placebo, 4,676 to arzoxifene 20 mg/d). There were 13 adjudicated cases of endometrial cancer (placebo, 4 cases; arzoxifene, 9 cases: P = 0.165) and 6 cases of endometrial hyperplasia (placebo, 2 cases; arzoxifene, 4 cases). Endometrial thickness, assessed at 24- and 36-month transvaginal ultrasounds in a subset of women, increased slightly in women assigned to arzoxifene compared with baseline and women in placebo. At the last measurement, 3 (1.7%) women assigned to placebo and 21 (10.2%) assigned to arzoxifene had an endometrial thickness greater than 5 mm (P < 0.001 for difference between treatment groups). Endometrial polyps were more common in women treated with arzoxifene (n = 37) than in women treated with placebo (n = 18; P < 0.05). Vulvular and vaginal inflammation, including mycotic infections, and vaginal discharge were reported more frequently in women treated with arzoxifene than in women treated with placebo, as were urinary tract infections. CONCLUSIONS: Gynecologic events were generally more common in women treated with arzoxifene than in women treated with placebo. The gynecologic effects of arzoxifene seem to differ from those of raloxifene, although both SERMs have a benzothiophene structure. Although all SERMs influence cells through the estrogen receptor, they need to be evaluated independently in terms of their effects on various tissues, including the genital tract
— id: 148741, year: 2012, vol: 19, page: 41, stat: Journal Article,

Pregnancy of unknown location: a consensus statement of nomenclature, definitions, and outcome
Barnhart, Kurt; van Mello, Norah M; Bourne, Tom; Kirk, Emma; Van Calster, Ben; Bottomley, Cecilia; Chung, Karine; Condous, George; Goldstein, Steven; Hajenius, Petra J; Mol, Ben Willem; Molinaro, Thomas; O'Flynn O'Brien, Katherine L; Husicka, Richard; Sammel, Mary; Timmerman, Dirk
2011 Mar 1;95(3):857-866, Fertility & sterility
OBJECTIVE: To improve the interpretation of future studies in women who are initially diagnosed with a pregnancy of unknown location (PUL), we propose a consensus statement with definitions of population, target disease, and final outcome. DESIGN: A review of literature and a series of collaborative international meetings were used to develop a consensus for definitions and final outcomes of women initially diagnosed with a PUL. RESULT(S): Global differences were noted in populations studied and in the definitions of outcomes. We propose to define initial ultrasound classification of findings into five categories: definite ectopic pregnancy (EP), probable EP, PUL, probable intrauterine pregnancy (IUP), and definite IUP. Patients with a PUL should be followed and final outcomes should be categorized as visualized EP, visualized IUP, spontaneously resolved PUL, and persisting PUL. Those with the transient condition of a persisting PUL should ultimately be classified as nonvisualized EP, treated persistent PUL, resolved persistent PUL, or histologic IUP. These specific categories can be used to characterize the natural history or location (intrauterine vs. extrauterine) of any early gestation where the initial location is unknown. CONCLUSION(S): Careful definition of populations and classification of outcomes should optimize objective interpretation of research, allow objective assessment of future reproductive prognosis, and hopefully lead to improved clinical care of women initially identified to have a PUL
— id: 133908, year: 2011, vol: 95, page: 857, stat: Journal Article,

Bone health medications: research questions versus clinical choices
Goldstein, Steven R
2011 Aug;18(8):835-836, Menopause
— id: 135581, year: 2011, vol: 18, page: 835, stat: Journal Article,

Introduction to a special section on the causality, diagnosis, and management of abnormal uterine bleeding
Goldstein, Steven R
2011 Apr;18(4):406-407, Menopause
— id: 134731, year: 2011, vol: 18, page: 406, stat: Journal Article,

Significance of incidentally thick endometrial echo on transvaginal ultrasound in postmenopausal women
Goldstein, Steven R
2011 Apr;18(4):440-442, Menopause
Postmenopausal bleeding is 'cancer until proven otherwise.' A thin distinct endometrial echo on transvaginal ultrasound has a risk of malignancy of 1 in 917 and does not require an endometrial biopsy. If the endometrial echo is poorly visualized, then in such women, saline infusion sonohysterography is an appropriate next step. The prevalence of asymptomatic endometrial thickening (mostly due to inactive polyps) is high, approximately 10% to 17% of postmenopausal women. The risk of malignancy in such polyps is low (approximately 0.1%), and in structures that mimic polyps, it is also low (0.3%). The incidence of serious complications from an operative intervention in such postmenopausal women is not insignificant (1.3%-3.6%). Thus, automatic intervention in such women, without any high-risk status, is not warranted
— id: 134732, year: 2011, vol: 18, page: 440, stat: Journal Article,

Postmenopausal Evaluation and Risk Reduction With Lasofoxifene (PEARL) trial: 5-year gynecological outcomes
Goldstein, Steven R; Neven, Patrick; Cummings, Steven; Colgan, Terence; Runowicz, Carolyn D; Krpan, Dalibor; Proulx, James; Johnson, Margot; Thompson, David; Thompson, John; Sriram, Usha
2011 Jan;18(1):17-22, Menopause
OBJECTIVE: The aim of this study was to establish the gynecological effects of 5 years of treatment with lasofoxifene versus placebo in postmenopausal osteoporotic women. METHODS: A total of 8,556 women aged 59 to 80 years with femoral neck or spine bone mineral density T scores of -2.5 or lower were randomized to receive lasofoxifene 0.25 mg/day, or lasofoxifene 0.5 mg/day, or placebo, for 5 years. RESULTS: Endometrial cancer was confirmed for two women in each lasofoxifene group and for three women in the placebo group. Endometrial hyperplasia occurred in three, two, and zero women in the lasofoxifene 0.25 mg/day, lasofoxifene 0.5 mg/day, and placebo groups, respectively. Vaginal bleeding occurred in 2.2% (P = 0.012 vs placebo), 2.6% (P = 0.001 vs placebo), and 1.3% of women treated with 0.25 mg/day lasofoxifene, 0.5 mg/day lasofoxifene, and placebo, respectively. Lasofoxifene treatment resulted in a small increase in endometrial thickness versus placebo (least-squares mean change from baseline 1.19 mm [P = 0.001], 1.43 mm [P < 0.001], and -0.72 mm for 0.25 mg/day lasofoxifene, 0.5 mg/day lasofoxifene, and placebo). Similar numbers of women required surgery for pelvic organ prolapse or urinary incontinence in the placebo and 0.5 mg/day lasofoxifene groups (1.2% vs 1.6%, P = 0.224; 0.25 mg/day group: 1.9%, P = 0.036). The absolute incidence rates of endometrial polyps were 8.8%, 5.5%, and 3.3% for lasofoxifene 0.25 mg/day (P = 0.003 vs placebo), lasofoxifene 0.5 mg/day (P = 0.163 vs placebo), and placebo groups, respectively. CONCLUSION: These findings indicate that 5 years of lasofoxifene treatment result in benign endometrial changes that do not increase the risk for endometrial cancer or hyperplasia in postmenopausal women
— id: 119224, year: 2011, vol: 18, page: 17, stat: Journal Article,

Lasofoxifene in Postmenopausal Women with Osteoporosis
Cummings, SR; Ensrud, K; Delmas, PD; LaCroix, AZ; Vukicevic, S; Reid, DM; Goldstein, S; Sriram, U; Lee, A; Thompson, J; Armstrong, RA; Thompson, DD; Powles, T; Zanchetta, J; Kendler, D; Neven, P; Eastell, R
2010 FEB 25 ;362(8):686-696, New England journal of medicine
BACKGROUND The effects of lasofoxifene on the risk of fractures, breast cancer, and cardiovascular disease are uncertain. METHODS In this randomized trial, we assigned 8556 women who were between the ages of 59 and 80 years and had a bone mineral density T score of -2.5 or less at the femoral neck or spine to receive once-daily lasofoxifene (at a dose of either 0.25 mg or 0.5 mg) or placebo for 5 years. Primary end points were vertebral fractures, estrogen receptor (ER)-positive breast cancer, and nonvertebral fractures; secondary end points included major coronary heart disease events and stroke. RESULTS Lasofoxifene at a dose of 0.5 mg per day, as compared with placebo, was associated with reduced risks of vertebral fracture (13.1 cases vs. 22.4 cases per 1000 person-years; hazard ratio, 0.58; 95% confidence interval [CI], 0.47 to 0.70), nonvertebral fracture (18.7 vs. 24.5 cases per 1000 person-years; hazard ratio, 0.76; 95% CI, 0.64 to 0.91), ER-positive breast cancer (0.3 vs. 1.7 cases per 1000 person-years; hazard ratio, 0.19; 95% CI, 0.07 to 0.56), coronary heart disease events (5.1 vs. 7.5 cases per 1000 person-years; hazard ratio, 0.68; 95% CI, 0.50 to 0.93), and stroke (2.5 vs. 3.9 cases per 1000 person-years; hazard ratio, 0.64; 95% CI, 0.41 to 0.99). Lasofoxifene at a dose of 0.25 mg per day, as compared with placebo, was associated with reduced risks of vertebral fracture (16.0 vs. 22.4 cases per 1000 person-years; hazard ratio, 0.69; 95% CI, 0.57 to 0.83) and stroke (2.4 vs. 3.9 cases per 1000 person-years; hazard ratio, 0.61; 95% CI, 0.39 to 0.96) Both the lower and higher doses, as compared with placebo, were associated with an increase in venous thromboembolic events (3.8 and 2.9 cases vs. 1.4 cases per 1000 person-years; hazard ratios, 2.67 [95% CI, 1.55 to 4.58] and 2.06 [95% CI, 1.17 to 3.60], respectively). Endometrial cancer occurred in three women in the placebo group, two women in the lower-dose lasofoxifene group, and two women in the higher-dose lasofoxifene group. Rates of death per 1000 person-years were 5.1 in the placebo group, 7.0 in the lower-dose lasofoxifene group, and 5.7 in the higher-dose lasofoxifene group. CONCLUSIONS In postmenopausal women with osteoporosis, lasofoxifene at a dose of 0.5 mg per day was associated with reduced risks of nonvertebral and vertebral fractures, ER-positive breast cancer, coronary heart disease, and stroke but an increased risk of venous thromboembolic events. (ClinicalTrials.gov number, NCT00141323.)
— id: 107734, year: 2010, vol: 362, page: 686, stat: Journal Article,

Selective estrogen receptor modulator: the saga continues
Goldstein, SR
2010 MAR ;17(2):231-232, Menopause
— id: 108778, year: 2010, vol: 17, page: 231, stat: Journal Article,

Modern evaluation of the endometrium
Goldstein, Steven R
2010 Jul;116(1):168-176, Obstetrics & gynecology
Abnormal uterine bleeding in women older than age 35 years, and certainly in menopausal patients, mandates evaluation, mainly to exclude cancer and hyperplasia, but also to better diagnose the source of the bleeding to appropriately manage the patient. In the past, dilation and curettage was the mainstay of diagnosis. This gave way to in-office suction pump-generated biopsies. Most recently, disposable biopsy instruments with their own internal piston to generate suction have become the standard of care. Rarely has such a technique received such widespread acceptance with such limited validation. Transvaginal ultrasonography, when technically feasible, is a noninvasive way to image the endometrial cavity. Saline-infusion sonohysterography is a subset of transvaginal ultrasonography reserved for patients in whom an adequate endometrial echo is not seen or when an endometrial echo is seen but not sufficiently thin. Appropriate understanding and use of transvaginal ultrasonography and addition of sonohysterography when necessary can allow a clinical algorithm that can triage patients with abnormal uterine bleeding to 1) no anatomic pathology best treated expectantly; 2) a global endometrial process, in which case random blind endometrial sampling is appropriate; or 3) a focal endometrial abnormality in which case endometrial sampling should be done with the visualization offered by hysteroscopy. Finally, the incidence of thick endometrial echo found incidentally in postmenopausal women with no bleeding is extremely high (10-17%) and should not trigger invasive endometrial sampling automatically
— id: 110087, year: 2010, vol: 116, page: 168, stat: Journal Article,

Reply
Goldstein, Steven R
2010 Mar;202(3):e11-e11, American journal of obstetrics & gynecology
— id: 107923, year: 2010, vol: 202, page: e11, stat: Journal Article,

Terms, definitions and measurements to describe the sonographic features of the endometrium and intrauterine lesions: a consensus opinion from the International Endometrial Tumor Analysis (IETA) group
Leone, F P G; Timmerman, D; Bourne, T; Valentin, L; Epstein, E; Goldstein, S R; Marret, H; Parsons, A K; Gull, B; Istre, O; Sepulveda, W; Ferrazzi, E; Van den Bosch, T
2010 Jan;35(1):103-112, Ultrasound in obstetrics & gynecology
The IETA (International Endometrial Tumor Analysis group) statement is a consensus statement on terms, definitions and measurements that may be used to describe the sonographic features of the endometrium and uterine cavity on gray-scale sonography, color flow imaging and sonohysterography. The relationship between the ultrasound features described and the presence or absence of pathology is not known. However, the IETA terms and definitions may form the basis for prospective studies to predict the risk of different endometrial pathologies based on their ultrasound appearance
— id: 134424, year: 2010, vol: 35, page: 103, stat: Journal Article,

Management of asymptomatic ovarian and other adnexal cysts imaged at US Society of Radiologists in Ultrasound consensus conference statement
Levine, Deborah; Brown, Douglas L; Andreotti, Rochelle F; Benacerraf, Beryl; Benson, Carol B; Brewster, Wendy R; Coleman, Beverly; DePriest, Paul; Doubilet, Peter M; Goldstein, Steven R; Hamper, Ulrike M; Hecht, Jonathan L; Horrow, Mindy; Hur, Hye-Chun; Marnach, Mary; Patel, Maitray D; Platt, Lawrence D; Puscheck, Elizabeth; Smith-Bindman, Rebecca
2010 Sep;26(3):121-131, Ultrasound quarterly
The Society of Radiologists in Ultrasound (SRU) convened a panel of specialists from gynecology, radiology, and pathology to arrive at a consensus regarding the management of ovarian and other adnexal cysts imaged sonographically in asymptomatic women. The panel met in Chicago, IL, on October 27-28, 2009, and drafted this consensus statement. The recommendations in this statement are based on analysis of current literature and common practice strategies, and are thought to represent a reasonable approach to asymptomatic ovarian and other adnexal cysts imaged at ultrasonography
— id: 133812, year: 2010, vol: 26, page: 121, stat: Journal Article,

Endometrial safety: a key hurdle for selective estrogen receptor modulators in development
Pinkerton, JV; Goldstein, SR
2010 MAY-JUN ;17(3):642-653, Menopause
Selective estrogen receptor modulators (SERMs) have the ability to provide mixed functional estrogen receptor (ER) agonist or antagonist activity, depending on the target tissue. Tamoxifen, the first SERM available for clinical use, is regarded as a highly effective agent for the prevention and treatment of breast cancer. However, tamoxifen exhibits ER agonist activity in the uterus and is associated with an increased risk of endometrial hyperplasia and malignancy. Endometrial safety has been an important consideration in the clinical development of SERMs, with improved benefit-risk profiles. Raloxifene, which is currently approved for the prevention and treatment of postmenopausal osteoporosis and for the prevention of breast cancer, seems to have neutral effects on the uterus. Promising results have been observed with the targeted development of newer and more tissue-specific SERMs, many of which are under investigation for postmenopausal osteoporosis. Of the newer SERMs in development, lasofoxifene has been shown to reduce fracture risk and decrease the incidence of breast cancer but has been associated with an increased incidence of vaginal bleeding, endometrial thickening, and endometrial polyps. Lasofoxifene and ospemifene have shown beneficial effects on the vaginal epithelium. Phase 3 clinical data have shown that bazedoxifene is effective in preventing and treating postmenopausal osteoporosis, without adverse effects on the endometrium or breast. Arzoxifene has been evaluated in phase 3 trials for postmenopausal osteoporosis and has been studied for the treatment of uterine malignancies but is no longer in clinical development. Further investigation of newer SERMs is warranted to more clearly define the endometrial safety of these agents
— id: 109708, year: 2010, vol: 17, page: 642, stat: Journal Article,

The role of transvaginal ultrasound or endometrial biopsy in the evaluation of the menopausal endometrium
Goldstein, Steven R
2009 Jul;201(1):5-11, American journal of obstetrics & gynecology
All postmenopausal women with vaginal bleeding need endometrial assessment. Disposable suction piston biopsy devices have virtually replaced dilatation and curettage despite little scientific validation. In patients with known carcinoma, false-negative rates with such devices range from 2.5-32.4%. Large prospective studies have shown that an endometrial thickness <or= 4 mm on transvaginal ultrasound in postmenopausal women with bleeding has a risk of malignancy of 1 in 917. Thus, in postmenopausal patients with bleeding, biopsy is not indicted when endometrial thickness is <or= 4 mm. The significance of a thick endometrial echo in nonbleeding postmenopausal women has not been validated and need not require automatic tissue sampling
— id: 100628, year: 2009, vol: 201, page: 5, stat: Journal Article,

Raloxifene use in clinical practice: efficacy and safety
Goldstein, Steven R; Duvernoy, Claire S; Calaf, Joaquim; Adachi, Jonathan D; Mershon, John L; Dowsett, Sherie A; Agnusdei, Donato; Stuenkel, Cynthia A
2009 Mar-Apr;16(2):413-421, Menopause
OBJECTIVE AND METHODS: In this article, we provide an interdisciplinary concise review of the effects of raloxifene on breast, bone, and reproductive organs, as well as the adverse events that may be associated with its use. RESULTS: Raloxifene has been shown to prevent osteoporosis in postmenopausal women (PMW) with low bone mass and prevent vertebral fractures in those with osteoporosis/low bone mass; it has not been shown to reduce the risk of nonvertebral fractures. Raloxifene reduces the risk of invasive breast cancer in PMW with osteoporosis or at high risk of breast cancer. The risk of venous thromboembolism has been consistently shown to be increased with raloxifene, so it should not be used in women at high risk of venous thromboembolism. Although raloxifene does not increase, nor decrease, the risk of coronary or stroke events overall, in the raloxifene trial of PMW at increased risk of coronary events, the incidence of fatal stroke was higher in women assigned raloxifene versus placebo. CONCLUSIONS: Based on its approved indications, it is appropriate to prescribe raloxifene to prevent or treat osteoporosis, as well as to reduce the risk of invasive breast cancer in PMW with osteoporosis or at high risk of breast cancer. Women at increased risk of both fracture and invasive breast cancer are those most likely to receive a dual benefit with raloxifene. Decision making must involve the incorporation of the woman's personal feelings about the risks and benefits of raloxifene therapy, balanced with her interest in reducing risk of fractures and breast cancer through pharmacological intervention
— id: 99317, year: 2009, vol: 16, page: 413, stat: Journal Article,

Vaginal Effects of Lasofoxifene: 3-Year Results from the PEARL Trial
Goldstein, SR; Cummings, SR; Eastell, R; Ensrud, K; Reid, DM; Vukicevic, S; LaCroix, A; Thompson, D; Thompson, J; Proulx, J; Johnson, M; Sriram, U
2008 NOV-DEC ;15(6):1228-1229, Menopause
— id: 90947, year: 2008, vol: 15, page: 1228, stat: Journal Article,

Early pregnancy: normal and abnormal
Goldstein, Steven R
2008 May;26(3):277-283, Seminars in reproductive medicine
The understanding of early pregnancy both normal and abnormal as seen by transvaginal ultrasound is an essential skill of any clinician involved in reproductive medicine and infertility. The 'sonomicroscopy' of the vaginal probe results from the high level of magnification and close proximity to the structure being studied. In addition, the ability to detect minute levels of human chorionic gonadotropin, often by over-the-counter home pregnancy tests, has caused patients to present to clinicians earlier then ever before. It is essential that the sonologist or sonographer understand what early pregnancy looks like on transvaginal ultrasound and why it looks like that, so that one can distinguish early pregnancies that are normal from those that are absolutely destined to fail. In addition, understanding the use of ultrasound and human chorionic gonadotropin in the modern diagnosis of ectopic pregnancy as well as a newly emerging category of pregnancies of unknown location is essential to clinical practice. This article will review the fundamental principals outlined above
— id: 80291, year: 2008, vol: 26, page: 277, stat: Journal Article,

To the editor. Use of transvaginal ultrasonography and sonohysterography
Goldstein, Steven R
2008 Mar-Apr;15(2):402-402, Menopause
— id: 135330, year: 2008, vol: 15, page: 402, stat: Journal Article,

Ultrasound scanning in reproductive medicine and infertility. Preface
Goldstein, Steven R
2008 May;26(3):215-215, Seminars in reproductive medicine
— id: 80290, year: 2008, vol: 26, page: 215, stat: Journal Article,

Electrical impedance scanning as a new breast cancer risk stratification tool for young women
Stojadinovic, A; Nissan, A; Shriver, CD; Mittendorf, EA; Akin, MD; Dickerson, V; Lenington, S; Platt, LD; Stavros, T; Goldstein, SR; Moskovitz, O; Gallimidi, Z; Fields, SI; Yeshaya, A; Allweis, TM; Manassa, R; Pappo, I; Ginor, RX; D'Agostino, RB; Gur, D
2008 FEB 1 ;97(2):112-120, Journal of surgical oncology
Background: Electrical impedance scanning (EIS) measures changes in breast tissue associated with breast cancer (Br-Ca) development. The T-Scan(tm2000 (ED is designed to use EIS to identify women ages 30-39 with elevated risk of breast cancer (i.e., T-Scan+ women). Aim: To estimate the relative probability of breast cancer in a T-Scan+ woman compared to a randomly selected young woman. Methods: A prospective, two-cohort trial was conducted in pre-menopausal women. The Specificity (S-p)-Cohort evaluated T-Scan specificity in 1,751 asymptomatic women ages 30-39. The Sensitivity)S-n)-Cohort evaluated T-Scan sensitivity in 390 women ages 45-30 scheduled for biopsy. Specificity, sensitivity, and conservative estimate of disease prevalence were used to calculate relative probability. Results: In the S-p-Cohort, 93 of 1,751 women were T-Scan+ (S-p = 94.7%; 95%
— id: 87149, year: 2008, vol: 97, page: 112, stat: Journal Article,

If it ain't broke, why are we fixing it?
Goldstein SR
2007 ;52(10):124- Oct, Contemporary ob/gyn
— id: 74918, year: 2007, vol: 52, page: 124, stat: Journal Article,

Predicting uterine weight before hysterectomy: Ultrasound measurements vs clinical assessment
Goldstein SR
2007 ;196(3):e16-, American journal of obstetrics & gynecology
— id: 71627, year: 2007, vol: 196, page: e16, stat: Journal Article,

Accreditation, certification: why all the confusion?
Goldstein, Steven R
2007 Dec;110(6):1396-1398, Obstetrics & gynecology
Tremendous confusion exists concerning the issues of physician certification and practice accreditation in obstetric and gynecologic ultrasonography. Certification speaks to physician competence. All obstetrician-gynecologists who have finished residency training since 1982 are deemed 'competent' to perform obstetric and gynecologic ultrasonography by virtue of their training. Those trained before 1982 need to be able to describe their level of experience in performing obstetric and gynecologic ultrasonography. Accreditation deals with issues of patient safety and quality control, including equipment calibration, transducer cleaning and disinfection, universal precautions and Occupational Safety and Health Administration regulations, ultrasound examination protocols, and qualifications of nonphysician personnel performing ultrasound examinations. A new field of radiology benefit managers has arisen in response to attempts by health insurers to manage care, and reduce their costs and utilization. They have adopted ultrasound accreditation, originally intended to enhance patient safety, to help restrict utilization. Currently two organizations are recognized as accrediting bodies: The American Institute of Ultrasound in Medicine (AIUM), which recognizes obstetric and gynecologic residency training as evidence of competency, and The American College of Radiologists, which does not. Obstetrician-gynecologists should realize that AIUM's accreditation is their 'lifeboat' in this time of increasing interference by health care insurers into decision making in clinical practice
— id: 75487, year: 2007, vol: 110, page: 1396, stat: Journal Article,

Raloxifene vs tamoxifen
Goldstein, Steven R
2007 Jan 17;297(3):263-264, JAMA
— id: 73835, year: 2007, vol: 297, page: 263, stat: Journal Article,

Ultrasound in gynecology
Timor-Tritsch, Ilan E; Goldstein, Steven R
Philadelphia : Elsevier Churchill Livingstone, 2007,
Ultrasound in gynecology: development and continuing evolution -- Applied physics: selecting and adjusting the equipment -- Instrumentation, modality selection, and documentation -- Conducting the gynecologic ultrasound examination -- Relevant pelvic anatomy -- Adenomyosis -- Congenital uterine anomalies -- Adnexal masses -- Menopausal dilemmas: how ultrasound has changed clinical management -- Lower urinary tract -- Early pregnancy -- Pregnancy failure -- Ectopic pregnancy -- Infertility -- Sonohysterography -- Ultrasound-guided procedures in gynecology -- Color doppler mapping in gynecology -- Transvaginal sonography and ovarian cancer -- Three-dimensional ultrasound in gynecology -- Ultrasound-enhanced bimanual examination -- Differential diagnosis of inflammatory diseases of the pelvis -- Pearls and pitfalls of transvaginal sonography
— id: 1387, year: 2007, vol: , page: , stat: ,

Pregnancies of unknown location: consensus statement
Condous, G; Timmerman, D; Goldstein, S; Valentin, L; Jurkovic, D; Bourne, T
2006 AUG ;28(2):121-122, Ultrasound in obstetrics & gynecology
— id: 67865, year: 2006, vol: 28, page: 121, stat: Journal Article,

Management of osteoporosis in postmenopausal women: 2006 position statement of The North American Menopause Society
Ettinger, B; Harris, ST; Kendler, D; Kessel, B; McClung, MR; Gorodeski, GI; Rothert, ML; Henderson, VW; Richardson, MK; Freedman, RR; Gallagher, JC; Goldstein, SR; Kessel, B; Pinkerton, JV; Reame, NK; Speroff, L; Stuenkel, CA; Schiff, I; Utian, WH; Graham, ID; Lammers, PK; Boggs, PP
2006 MAY-JUN ;13(3):340-367, Menopause
Objective: To update the evidence-based position statement published by The North American Menopause Society (NAMS) in 2002 regarding the management of osteoporosis in postmenopausal women. Design: NAMS followed the general principles established for evidence-based guidelines to create this updated document. A panel of clinicians and researchers expert in the field of metabolic bone diseases and/or women's health was enlisted to review the 2002 NAMS position statement, compile supporting statements, and reach consensus on recommendations. The panel's recommendations were reviewed and approved by the NAMS Board of Trustees. Results: Osteoporosis, whose prevalence is especially high among elderly postmenopausal women, increases the risk of fractures. Hip and spine fractures are associated with particularly high morbidity and mortality in this population. Given the health implications of osteoporotic fractures, the primary goal of osteoporosis therapy is to prevent fractures, which is accomplished by slowing or stopping bone loss, maintaining bone strength, and minimizing or eliminating factors that may contribute to fractures. The evaluation of postmenopausal women for osteoporosis risk requires a medical history, physical examination, and diagnostic tests. Major risk factors for postmenopausal osteoporosis (as defined by bone mineral density) include advanced age, genetics, lifestyle factors (such as low calcium and vitamin D intake, smoking), thinness, and menopause status. The most common risk factors for osteoporotic fracture are advanced age, low,bone mineral density, and previous fracture as an adult. Management focuses first on nonpharmacologic measures, such as a balanced diet, adequate calcium and vitamin D intake, adequate exercise, smoking cessation, avoidance of excessive alcohol intake, and fall prevention. If pharmacologic therapy is indicated, government-approved options are bisphosphonates, a selective estrogen-receptor modulator, parathyroid hormone, estrogens, and calcitonin. Conclusions: Management strategies for postmenopausal women involve identifying those at risk of low bone density and fracture, followed by instituting measures that focus on reducing modifiable risk factors through lifestyle changes and, if indicated, pharmacologic therapy
— id: 64624, year: 2006, vol: 13, page: 340, stat: Journal Article,

Not all selective estrogen response modulators are created equal: update on lasofoxifene
Goldstein, S R
2006 ;16 Suppl 2:504-504, International journal of gynecological cancer
— id: 71231, year: 2006, vol: 16 Suppl 2, page: 504, stat: Journal Article,

Not all SERMs are created equal
Goldstein, SR
2006 MAY-JUN ;13(3):325-327, Menopause
— id: 64623, year: 2006, vol: 13, page: 325, stat: Journal Article,

Effects of raloxifene on the incidence of invasive breast cancer in postmenopausal women at low and high risk of breast cancer by the gail model
Goldstein, SR; Mershon, J; Wong, M; Natanegara, F; Mitchell, BD
2006 NOV-DEC ;13(6):1001-1001, Menopause
— id: 70748, year: 2006, vol: 13, page: 1001, stat: Journal Article,

Abnormal uterine bleeding: the role of ultrasound
Goldstein, Steven R
2006 Nov;44(6):901-910, Radiologic clinics of North America
Abnormal uterine bleeding is an important clinical concern and accounts for much medical intervention. This article presents an ultrasound-based approach to help exclude endometrial carcinoma and identify the source of bleeding for better clinical management. Saline infusion sonohysterography can help to triage patients to (1) no anatomic pathology, (2) globally thickened anatomic pathology that may be evaluated with blind endometrial sampling, or (3) focal abnormalities that must be evaluated under direct vision
— id: 70316, year: 2006, vol: 44, page: 901, stat: Journal Article,

Attempt to reduce the progestogen component in hormone therapy
Goldstein, Steven R
2006 May-Jun;13(3):538-538, Menopause
— id: 67925, year: 2006, vol: 13, page: 538, stat: Journal Article,

The complexity of a "complex mass" and the simplicity of a "simple cyst"
Timor-Tritsch, Ilan E; Goldstein, Steven R
2005 Mar;24(3):255-258, Journal of ultrasound in medicine
— id: 76494, year: 2005, vol: 24, page: 255, stat: Journal Article,

Transrectal scanning: an alternative when transvaginal scanning is not feasible
Timor-Tritsch, I E; Monteagudo, A; Rebarber, A; Goldstein, S R; Tsymbal, T
2003 May;21(5):473-479, Ultrasound in obstetrics & gynecology
OBJECTIVE: In scanning the female pelvis the clear images of transvaginal sonography (TVS) result from placing the transducer close to the region of interest. The advantages of TVS over transabdominal sonography (TAS) and transperineal sonography are well documented. Transrectal scanning is proposed mostly for ultrasound guidance in draining a pelvic abscess. Our aim was to investigate the applicability of transrectal scanning (TRS) for cases in which TVS is impossible. METHODS: Forty-two patients with an absolute or a relative contraindication to TVS were scanned transabdominally and transrectally. The TRS was performed using a transvaginal probe, which was lubricated and slowly advanced into the rectum. The technique used was similar to that of TVS. Images were compared for resolution and quality. RESULTS: All scans were completed without significant patient discomfort or complaints. TRS was clearly superior to TAS in 31 cases. In nine cases TAS furnished some clinical information but TRS yielded better images. Only in one such case was TAS similar in quality to TRS. In four obese patients TAS did not reveal sufficient pelvic anatomy to generate a clinical diagnosis, whereas TRS revealed two sets of normal ovaries and two patients with ovarian cysts. In the two cases with vaginal agenesis TRS revealed the diagnosis of Rokitansky-Kuster syndrome. In three of the four patients with ruptured membranes the cervix could be measured precisely. CONCLUSION: Transrectal scanning should be used liberally after proper patient selection and counseling. The images obtained are superior to TAS and comparable to those obtained by TVS
— id: 76498, year: 2003, vol: 21, page: 473, stat: Journal Article,

Transvaginal ultrasound-assisted gynecologic surgery: evaluation of a new device to improve safety of intrauterine surgery
Timor-Tritsch, Ilan E; Masch, Rachel J; Goldstein, Steven R; Ng, Eliza; Monteagudo, Ana
2003 Oct;189(4):1074-1079, American journal of obstetrics & gynecology
OBJECTIVE: The purpose of this study was to evaluate a new device that couples any standard transvaginal ultrasound transducer to a special tenaculum by means of a specially designed adaptor that enables real-time ultrasound imaging and guidance of intrauterine surgical procedures. STUDY DESIGN: Forty-five patients who underwent intrauterine surgical interventions were evaluated. Forty of these patients had pregnancy terminations. Three patients had curettage for early pregnancy complications. One patient had a polyp removed, and one patient underwent hysteroscopic submucous myomectomy. Five attending physicians performed 26 procedures. Four residents in training performed 19 procedures. All operators were instructed in the assembly and use of the device before their first procedure. Evaluation of the device was done by means of a detailed questionnaire. RESULTS: The procedures were completed successfully and without complications. The time that was involved for the various components of the surgical procedures was recorded; 83% to 90% of the time the operators felt that the technique increased safety and accuracy for the parameters that were evaluated. They required fewer intrauterine instrument manipulations; in 85% of the cases, they could detect the exact end point of the procedure more accurately. In 12% of cases, the operators felt that the device interfered with the performance of the procedure. CONCLUSIONS: The transvaginal ultrasound-assisted gynecological surgery system provided high-resolution images of the cervical canal and the uterine cavity during all stages of the procedure and provided improved indication of the procedure's end point. The increased safety and accuracy that was reported by most users was encouraging. The transvaginal ultrasound-assisted gynecologic surgery system appears to provide an enhanced alternative to transabdominal ultrasound guidance for intrauterine surgical procedures
— id: 38995, year: 2003, vol: 189, page: 1074, stat: Journal Article,

Incidence and severity of urinary incontinence in postmenopausal women participating in a placebo-controlled clinical trial of raloxifene and estrogen
Ciaccia, A; Goldstein, S; Johnson, S; Watts, S; Draper, M; Plouffe, L
2002 Apr;50(4):P378-P378, Journal of the American Geriatrics Society
— id: 27447, year: 2002, vol: 50, page: P378, stat: Journal Article,

An update on non-uterine gynaecological effects on raloxifene
Goldstein, S R
2002 Nov;38 Suppl 6(11):S65-S66, European journal of cancer
— id: 39379, year: 2002, vol: 38 Suppl 6, page: S65, stat: Journal Article,

1997's screening consensus redebated
Goldstein, SR
2002 NOV ;38(12):S42-S43, European journal of cancer
— id: 33275, year: 2002, vol: 38, page: S42, stat: Journal Article,

Routine use of office gynecologic ultrasound
Goldstein, SR
2002 MAY ;21(5):489-492, Journal of ultrasound in medicine
— id: 55310, year: 2002, vol: 21, page: 489, stat: Journal Article,

Controversy about uterine effects and safety of SERMs: the saga continues
Goldstein, Steven R
2002 Sep-Oct;9(5):381-384, Menopause
From the perspective of endometrial safety, there has been great controversy about what special management, if any, tamoxifen-treated patients should undergo. Periodic blind endometrial sampling or transvaginal ultrasound has been advocated by some. Because of the problems associated with either of these techniques alone, we recommended an approach that used transvaginal ultrasound and then proceeded to sonohysterography when the endometrial echo on transvaginal ultrasound was not reliably thin and distinct. The American College of Obstetricians and Gynecologists (ACOG), in its committee opinion, stated that patients receiving tamoxifen therapy should only have an annual pelvic exam with pap smear if they remain asymptomatic. Newer data suggest, however, that there are high- and low-risk groups that can be identified by pretreatment screening. Before tamoxifen therapy, 17% of patients have polyps. These patients have 17 times the incidence of atypical hyperplasia than those whose uterus was negative before tamoxifen therapy. Such findings call into question the validity of the only study of raloxifene where uterine safety was the primary endpoint. In that study, any woman with baseline endometrial findings other than pristinely negative (i.e., low risk) was excluded. However, other raloxifene studies without pretreatment screening show relative risk (RR) = 0.8 (95% CI = 0.2, 2.7) for endometrial carcinoma. This compares with the women over 50 years of age in the Breast Cancer Prevention Trial (National Surgical Adjuvant Breast and Bowel Project P-1) with tamoxifen when the RR = 4.01 (95% CI= 1.70, 10.90). The existence of potentially high- and low-risk groups should be taken into account in any future clinical trials looking at the endometrial safety of selective estrogen receptor modulators (SERMs)
— id: 39407, year: 2002, vol: 9, page: 381, stat: Journal Article,

Evaluation of endometrial polyps
Goldstein, Steven R; Monteagudo, Ana; Popiolek, Dorota; Mayberry, Pat; Timor-Tritsch, Ilan
2002 Apr;186(4):669-674, American journal of obstetrics & gynecology
OBJECTIVE: Endometrial polyps are relatively common in all groups of women. More polyps are being diagnosed with the widespread use of transvaginal ultrasound scanning and sonohysterography. The reported incidence of malignancy is low. The potential benefit of a noninvasive technique to distinguish benign from malignant polyps is obvious. This study was undertaken to evaluate endometrial polyps by color flow Doppler ultrasound scanning and histopathologic examination. STUDY DESIGN: This was an observational study of patients with an endometrial polyp on sonohysterography who underwent interrogation of their polyp with color Doppler ultrasound scanning and subsequently polypectomy. Polyp volume, resistive index, pulsatility index, indication for scan (bleeding vs incidental), and patient age were correlated with histopathologic type of the polyp (nonfunctional, proliferative, secretory, hyperplastic, or malignant). RESULTS: Of 61 patients studied, 42 patients (68.9%) were scanned for abnormal bleeding, and 19 patients (31.1%) had their polyps discovered incidentally. There were no statistically significant differences between histologic categories and the resistive index, pulsatility index, or size of the polyp. The age of patients with nonfunctional polyps was significantly greater than any other group (P <.001). Ninety-four percent of the functional polyps were discovered because of abnormal bleeding; 38% of the nonfunctional polyps were discovered incidentally (P <.001). CONCLUSION: The data suggest that the objective assessment of blood flow impedance (resistive index, pulsatility index) in endometrial polyps and the size of these polyps cannot replace surgical removal and pathologic evaluation to predict histologic type. Patients with nonfunctional polyps were older and less likely to have vaginal bleeding
— id: 39671, year: 2002, vol: 186, page: 669, stat: Journal Article,

Adverse events that are associated with the selective estrogen receptor modulator levormeloxifene in an aborted phase III osteoporosis treatment study
Goldstein, Steven R; Nanavati, Nayan
2002 Sep;187(3):521-527, American journal of obstetrics & gynecology
OBJECTIVE: Selective estrogen receptor modulators are novel compounds that bind to the estrogen receptor and have mixed agonistic and antagonistic activities. Recently, an increase in urinary incontinence has been reported with hormone replacement therapy use. A decrease in surgical procedures for pelvic floor relaxation has been recently reported with raloxifene, a selective estrogen receptor modulator that is not uterotropic. Levormeloxifene is a selective estrogen receptor modulator that was developed for the purpose of the treatment and prevention of postmenopausal osteoporosis. STUDY DESIGN: This was a multicentered prospective study of healthy women aged >or=65 years with osteoporosis who were randomized to blindly receive placebo or levormeloxifene 0.5 mg or 1.25 mg daily as part of a planned 3-year osteoporosis treatment study. Multiple medical and gynecologic evaluations were performed. Adverse events were reported to investigators and coded with the use of World Health Organization terminology. This study was halted after 10 months because of the large number of gynecologic and other adverse events. RESULTS: Among 2924 women who were studied, those women who were treated with levormeloxifene had a marked increase compared with placebo in leukorrhea (30% vs 3%), increased endometrial thickness on ultrasound scan (19% vs 1%), enlarged uterus (17% vs 3%), uterovaginal prolapse (7% vs 2%), urinary incontinence (17% vs 4%), increased micturition frequency (9% vs 4%), lower abdominal pain (17% vs 6%), hot flushes (10% vs 3%), and leg cramps (6% vs 0.8%). All of these differences were highly statistically significant with a probability value of.0001 for each. CONCLUSION: Levormeloxifene results in multiple adverse gynecologic and other events in postmenopausal women with osteoporosis
— id: 39590, year: 2002, vol: 187, page: 521, stat: Journal Article,

The effect of raloxifene on the incidence of ovarian cancer in postmenopausal women
Neven, P; Goldstein, SR; Ciaccia, AV; Zhou, LF; Silfen, SL; Muram, D
2002 May;85(2):388-390, Gynecologic oncology
Objective. The aim of this study was to determine the incidence of ovarian cancer in postmenopausal women treated with raloxifene compared with placebo. Methods. This analysis comprises integrated data from seven randomized, placebo- controlled trials of raloxifene (N = 9837). Ovarian cancer cases were identified from the safety database and reviewed by a gynecologic adjudication review board. Results. Sixteen cases of ovarian cancer were reported: 8 women (70.4/100,000 patient- years) on placebo and 8 (37.4/100,000 patient-years) on pooled raloxifene doses. The relative risk of ovarian cancer associated with raloxifene therapy was 0.50 (95% confidence interval, 0.19-1.35). Conclusion. Raloxifene use was not associated with an increased risk for ovarian cancer. (C) 2002 Elsevier Science (USA)
— id: 27440, year: 2002, vol: 85, page: 388, stat: Journal Article,

Imaging of the infertile couple
Benson, Carol B; Goldstein, Steven R.
London : Martin Dunitz, 2001,
— id: 717, year: 2001, vol: , page: , stat: ,

The effect of SERMs on the endometrium
Goldstein SR
2001 Dec;949(5):237-242, Annals of the New York Academy of Sciences
Tamoxifen, the first clinically available SERM, was developed in 1966 and approved by the FDA (United States Food and Drug Administration) in 1978. It is the most prescribed antineoplastic drug in the world, with approximately 10 million women-use-years of experience. Tamoxifen has proved efficacious in all settings of breast cancer. However, in the mid-to-late 1980s, a series of letters to the editor and case reports announced an association between tamoxifen therapy in women with breast cancer and the development of endometrial carcinoma. Subsequently, in 1998, the observation of a significant 49% reduction in invasive breast cancer relative to placebo in a cohort of women at increased risk for the disease resulted in the early stopping of the National Surgical Adjuvant Breast and Bowel Project's (NSABP) P-1: Breast Cancer Prevention Trial (BCPT). Importantly, this was the first time that information became available about the effects of tamoxifen in healthy women, that is, women who did not already have breast cancer. In this healthy population, the relative risk of developing endometrial carcinoma in the tamoxifen arm was 2.54, although when stratified by age, in women over 50, the risk grew to 4.01. Thus, the risk appears to be confined to women over 50 because, in contrast, in women under 50 there was no statistically significant increase in the risk of endometrial carcinoma
— id: 39437, year: 2001, vol: 949, page: 237, stat: Journal Article,

Raloxifene effect on frequency of surgery for pelvic floor relaxation(1)
Goldstein SR; Neven P; Zhou L; Taylor YL; Ciaccia AV; Plouffe L
2001 Jul;98(1):91-96, Obstetrics & gynecology
Objective:To assess the effects of raloxifene therapy on the frequency of surgery for pelvic floor relaxation in postmenopausal women.Methods:This analysis used safety data through 3 years of treatment from three double-masked, placebo-controlled, randomized trials of raloxifene, which included 6926 postmenopausal women with uteri at entry. Studies 1 and 2 enrolled 969 nonosteoporotic, postmenopausal women who were assigned to 30, 60, or 150 mg per day raloxifene or placebo. Study 3 enrolled 5957 osteoporotic, postmenopausal women randomized to raloxifene 60 or 120 mg per day or placebo. Indications for any reported pelvic operations were identified, including procedures performed for pelvic organ prolapse or urinary incontinence.Results:A total of 34 (1.51%) women in the placebo group and 35 (0.75%) raloxifene-treated women underwent surgical procedures for pelvic floor relaxation. The odds ratio (and 95% confidence interval) for pelvic floor repair in women assigned to raloxifene was 0.50 (0.31, 0.81). Thus, raloxifene therapy was associated with a significantly reduced risk for pelvic floor surgery (P <.005).Conclusion:Raloxifene does not increase pelvic floor relaxation. An apparent protective effect on pelvic floor function warrants further investigation
— id: 21160, year: 2001, vol: 98, page: 91, stat: Journal Article,

Drugs for the gynecologist to prescribe in the prevention of breast cancer: current status and future trends
Goldstein SR
2000 May;182(5):1121-1126, American journal of obstetrics & gynecology
Tamoxifen was approved for breast cancer prevention in October 1998. Thus, for the first time, we as gynecologists are being asked to prescribe this drug to healthy women. In the past each one of us has cared for women with breast cancer who have been treated with tamoxifen by oncologists or breast surgeons for the malignancy. Effects of tamoxifen on the uterus resulting in carcinomas, hyperplasia, and polyps are well known. Furthermore, tamoxifen has estrogenic properties in the venous system, increasing the incidence of deep vein thrombosis and pulmonary emboli. A new SERM (selective estrogen receptor modulator), raloxifene, has been approved for prevention and treatment of osteoporosis in postmenopausal women. It does not have stimulatory effects on the endometrium; however, it is estrogenic in the venous system. Preclinical data, as well as the breast cancer incidence reported in studies of the skeleton, seem to indicate that its effects in the breast are similar to those of tamoxifen. This article reviews tamoxifen and the new SERM, raloxifene, in an attempt to help gynecologists better understand each compound and what data are currently known, what we hope to learn from future studies, and what currently makes sense for clinical practice
— id: 11690, year: 2000, vol: 182, page: 1121, stat: Journal Article,

Update on raloxifene to prevent endometrial-breast cancer
Goldstein SR
2000 Sep;36 Suppl 4(2):S54-S56, European journal of cancer
In the mid 1980s when tamoxifen was shown to be associated with endometrial neoplasia there was a renewed interest in another SERM compound, raloxifene. Experimental animal data suggested that raloxifene did not stimulate the endometrium as tamoxifen does while having similar anti-oestrogenic effects in breast tissue as tamoxifen. Clinical data has now shown that raloxifene does not stimulate the endometrium in postmenopausal women. It results in no hyperplasia, no increase in endometrium thickness or polyp formation and virtually no proliferation. Further studies are necessary to see if long-term raloxifene use will reduce the risk of endometrial cancer. In studies of raloxifene as treatment for osteoporosis, when viewed as a secondary endpoint there was a significant reduction in risk of new onset breast cancer. Further studies with breast cancer as a primary endpoint are ongoing (the STAR Trial)
— id: 39528, year: 2000, vol: 36 Suppl 4, page: S54, stat: Journal Article,

A 12-month comparative study of raloxifene, estrogen, and placebo on the postmenopausal endometrium
Goldstein SR; Scheele WH; Rajagopalan SK; Wilkie JL; Walsh BW; Parsons AK
2000 Jan;95(1):95-103, Obstetrics & gynecology
OBJECTIVE: To determine the effects of a selective estrogen receptor modulator, raloxifene, on postmenopausal endometrium. METHODS: Healthy postmenopausal women (n = 415) were randomly assigned to one of the following four groups: 60 or 150 mg/day raloxifene hydrochloride, 0.625 mg/day conjugated equine estrogens, or placebo, and treated for 1 year. Endometrial biopsies were obtained in a blinded fashion at baseline and every 6 months after the ultrasound studies. Transvaginal ultrasound, with uterine size measurements, was done at baseline and at 3-month intervals. Saline-infusion sonohysterography was done at baseline and every 6 months. RESULTS: There were no statistically significant differences in baseline characteristics. Mean endometrial thickness, measured by transvaginal ultrasound, was unchanged from baseline to end point in the placebo and raloxifene groups, whereas in the estrogen group it was significantly thicker by 5.5 mm (P < .001). Mean uterine volume, calculated from transvaginal ultrasound measurements, was higher in the estrogen group only (22 cm3, P < .001). Of the 358 women with paired biopsies, endometrial hyperplasia was present in 2.1%, 0%, and 26.1% of the end-point biopsies in the placebo, raloxifene, and estrogen groups, respectively (P < .001). Proliferative endometrium was present in 2.1% of the end-point biopsies in the placebo group, 1.7% in the combined raloxifene groups, and 39.8% in the estrogen group (P < .001). CONCLUSION: Raloxifene, at 60 or 150 mg/day for 1 year, did not stimulate the postmenopausal endometrium. End-point endometrial thickness, morphology, and uterine volume in the raloxifene groups were similar to those observed at baseline and in the placebo group
— id: 11862, year: 2000, vol: 95, page: 95, stat: Journal Article,

A pharmacological review of selective oestrogen receptor modulators [In Process Citation]
Goldstein SR; Siddhanti S; Ciaccia AV; Plouffe L Jr
2000 May-Jun;6(3):212-224, Human reproduction update
Selective oestrogen receptor modulators (SERMs) are structurally diverse non-steroidal compounds that bind to oestrogen receptors and produce oestrogen agonist effects in some tissues and oestrogen antagonist effects in others. SERMs are being evaluated for a number of oestrogen-related diseases, including post-menopausal osteoporosis, hormone-dependent cancers, and cardiovascular disease. Several compounds that exhibit a SERM profile are currently available for clinical use, including clomiphene, tamoxifen, and toremifene (which are triphenylethylenes) and raloxifene (a benzothiophene). Clomiphene is used for the induction of ovulation in sub-fertile women attempting pregnancy. Tamoxifen and toremifene are both used to treat breast cancer. Tamoxifen may have beneficial effects on bone mineral density and serum lipids. The effects of toremifene on serum lipids are similar to that of tamoxifen. Both compounds have stimulatory effects on the endometrium. Raloxifene, indicated for the treatment and prevention of post-menopausal osteoporosis, has beneficial effects on bone mineral density and serum lipids, but does not increase the risk of endometrial hyperplasia or endometrial cancer. Recently, raloxifene was shown to reduce the incidence of vertebral fractures in otherwise healthy women with osteoporosis; in the same study, a reduced incidence of breast cancer was also observed. Similar to oestrogens, SERMs increase the incidence of venous thromboembolism. Several newer compounds that exhibit a SERM profile are also in clinical development, including other triphenylethylenes (droloxifene, idoxifene) and benzothiophenes (LY353381.HCl), benzopyrans (EM-800), and naphthalenes (CP-336,156)
— id: 11630, year: 2000, vol: 6, page: 212, stat: Journal Article,

Abnormal uterine bleeding : an ultrasound approach
Goldstein, Steven R
Secaucus NJ : Network for Continuing Medical Education, 2000,
Abnormal uterine bleeding can be experienced by a woman at any age. If organic pathology is absent, the bleeding is either anovulatory in premenopausal women or atrophic in menopausal women. Sonography, in the form of saline infusion sonohysterography (SIS), has gained widespread use as a useful tool for diagnosing this problem in women. Once the domain of obstetricians, the use of endovaginal probes with fluid instillation can enhance the assessment of the endometrium. Dr. Goldstein offers a step-wise approach to the diagnosis, evaluation, and treatment of abnormal uterine bleeding with a special emphasis on using this procedure to its fullest advantage
— id: 1383, year: 2000, vol: , page: , stat: ,

Effect of SERMs on breast tissue
Goldstein SR
1999 Sep;22(8):636-640, Journal of endocrinological investigation
— id: 11940, year: 1999, vol: 22, page: 636, stat: Journal Article,

Further attempts to refine our diagnostic capabilities in potential ectopic pregnancies
Goldstein SR
1999 Oct;14(4):229-230, Ultrasound in obstetrics & gynecology
— id: 6249, year: 1999, vol: 14, page: 229, stat: Journal Article,

Reply [In Process Citation]
Goldstein SR
1999 Oct;181(4):1036-1036, American journal of obstetrics & gynecology
— id: 11945, year: 1999, vol: 181, page: 1036, stat: Journal Article,

Selective estrogen receptor modulators: a new category of compounds to extend postmenopausal women's health
Goldstein SR
1999 Sep-Oct;44(5):221-226, International journal of fertility & women's medicine
Selective estrogen receptor modulators (SERMs) are a new category of therapeutic agents, which bind with high affinity to estrogen receptors and mimic the effect of estrogens in some tissues but act as estrogen antagonists in others. Tamoxifen, a triphenylethylene derivative, was the first clinically available SERM. It is a potent anti-estrogen in the breast, and its use in breast cancer patients has made it the most widely prescribed antineoplastic drug worldwide. It has estrogen-like activity on bone metabolism, as well as cholesterol reduction. However, its ability to produce proliferation, and polyp formation, and even carcinomas, in the endometrium is well known. A new SERM, raloxifene, a benzothiopene derivative, has a clinical profile similar to tamoxifen's. However, preclinical as well as clinical studies reveal that unlike tamoxifen it is a pure anti-estrogen in the uterus. It has recently been FDA approved for prevention of osteoporosis in postmenopausal women. This report reviews pertinent preclinical and currently available clinical studies about this new SERM and discusses clinical applicability
— id: 6243, year: 1999, vol: 44, page: 221, stat: Journal Article,

Effect of raloxifene on the endometrium: Will this be the ultimate key to its utilization?
Goldstein, SR
1999 ;6(3):183-185 FAL, Menopause
— id: 53958, year: 1999, vol: 6, page: 183, stat: Journal Article,

Endometrial safety during hormone replacement therapy: comparison of transvaginal sonography and endometrial biopsy
Goldstein SR
1998 Summer;5(2):132-133, Menopause
— id: 63290, year: 1998, vol: 5, page: 132, stat: Journal Article,

Selective estrogen receptor modulators: a new category of therapeutic agents for extending the health of postmenopausal women [see comments]
Goldstein SR
1998 Dec;179(6 Pt 1):1479-1484, American journal of obstetrics & gynecology
Selective estrogen receptor modulators are a new category of therapeutic agents that bind with high affinity to estrogen receptors and mimic the effect of estrogens in some tissues but act as estrogen antagonists in others. Tamoxifen, a triphenylethylene derivative, was the first clinically available selective estrogen receptor modulator. It is a potent antiestrogen in the breast, and its use in breast cancer patients has made it the most prescribed antineoplastic drug worldwide. It has estrogen-like activity on bone metabolism, and it also reduces cholesterol. However, its ability to produce proliferation, polyp formation, and even carcinomas in the endometrium is well known. A new selective estrogen receptor modulator, raloxifene, a benzothiopene derivative, has a clinical profile similar to that of tamoxifen. However, both preclinical and clinical studies reveal that, unlike tamoxifen, it is a pure antiestrogen in the uterus. It has recently been approved by the Food and Drug Administration for prevention of osteoporosis in postmenopausal women. This report reviews pertinent preclinical and currently available clinical studies about this new selective estrogen receptor modulator and discusses clinical applicability
— id: 12051, year: 1998, vol: 179, page: 1479, stat: Journal Article,

Use of transvaginal ultrasonography to monitor the effects of tamoxifen on uterine leiomyoma size and ovarian cyst formation
Schwartz LB; Rutkowski N; Horan C; Nachtigall LE; Snyder J; Goldstein SR
1998 Nov;17(11):699-703, Journal of ultrasound in medicine
To evaluate the effects of tamoxifen on leiomyomas and ovarian cysts in postmenopausal breast cancer patients, uterine and leiomyoma volumes were monitored sonographically in 17 postmenopausal women receiving postoperative tamoxifen for breast cancer; patients were examined twice with a mean of 1.18 +/- 0.17 years between examinations. The mean increase in leiomyoma volume was 1.26 +/- 0.73 cm3. The mean myoma volume was significantly larger at follow-up evaluation than at initial ultrasonography (5.75 +/- 1.09 cm3 versus 4.36 +/- 0.817 cm3, respectively; Wilcoxon signed rank test, P = 0.0218). Six women developed new leiomyomas. Of the 21 leiomyomas initially detected, 13 increased, six decreased, and two were unchanged in volume. The mean increase in uterine volume was 17.45 +/- 8.49 cm3. Three patients had simple ovarian cysts at initial ultrasonographic examination, two of which remained unchanged in size, and the third resolved. Two patients had newly developed simple ovarian cysts. The increase in uterine and leiomyoma volumes with the development of new leiomyomas and the persistence or development of ovarian cysts in some patients support the existence of agonistic tamoxifen effects. Serial measurements of uterine and leiomyoma volumes and surveillance for ovarian cysts is recommended for tamoxifen users
— id: 12060, year: 1998, vol: 17, page: 699, stat: Journal Article,

The use of transvaginal ultrasound and saline infusion sonohysterography for the evaluation of asymptomatic postmenopausal breast cancer patients on tamoxifen
Schwartz LB; Snyder J; Horan C; Porges RF; Nachtigall LE; Goldstein SR
1998 Jan;11(1):48-53, Ultrasound in obstetrics & gynecology
Tamoxifen has been shown to decrease the recurrence rate of breast cancer. Evidence that tamoxifen use may be associated with an increased risk of endometrial cancer has caused investigators to recommend routine invasive sampling. We have assessed a minimally invasive alternative for endometrial surveillance of tamoxifen-treated patients utilizing transvaginal ultrasound and saline infusion sonohysterography. Asymptomatic women (n = 44) with breast cancer on postoperative tamoxifen treatment were referred to our gynecological ultrasound unit. Initially, the endometrial echo was measured with unenhanced transvaginal ultrasound. If a distinct echo measured < or = 5 mm, no further procedure was performed. For thickened or inadequately visualized echoes, sonohysterography was performed. If a thin echo was noted on sonohysterography, no further procedure was performed. If focal changes were detected, hysteroscopy/dilatation and curettage (D&C) was performed. For generalized symmetrically thickened echoes, a blind biopsy was done. If sonohysterography was unsuccessful, hysteroscopy/D&C was performed. Eleven (25%) patients had thin unenhanced echoes of < or = 5 mm. Twenty-five (57%) patients had thickened endometrial echoes. Three (7%) had naturally occurring endometrial fluid outlining a polyp. An endometrial echo could not be visualized in five (11%) patients. Sonohysterography was successfully performed in 21 out of 30 (70%) patients with either thickened or non-visualized unenhanced echoes. Of these, two patients had thin endometria with coexisting myomas; seven had thin endometria with typical tamoxifen-induced subendometrial changes: and seven had focal polypoid thickening confirmed by hysteroscopy/D&C. Histology revealed carcinoma associated with two, proliferation in one and four polyps. Five patients had thickened unenhanced echoes with symmetrically thickened single-layer measurements on sonohysterography. Histology revealed that three were proliferative, one was inactive and one was hyperplastic. In the nine patients with unsuccessful sonohysterography, hysteroscopy/D&C revealed inactive endometria in six, and three polyps. Our paradigm of evaluating the endometrial response to tamoxifen is concluded to overcome the shortcomings of either unenhanced transvaginal ultrasound or blind biopsy alone while it kept the number of invasive sampling procedures to 55% (24 out of 44)
— id: 7783, year: 1998, vol: 11, page: 48, stat: Journal Article,

Evaluation of abnormal vaginal bleeding in perimenopausal women with endovaginal ultrasound and saline infusion sonohysterography
Goldstein SR; Schwartz LB
1997 Sep 26;828:208-212, Annals of the New York Academy of Sciences
Saline infusion sonohysterography enhances endovaginal ultrasound examination of the uterine cavity in perimenopausal patients with abnormal uterine bleeding. It is easily and rapidly performed at minimal cost, is extremely well tolerated by patients, and is virtually devoid of complications. Its use can prevent invasive diagnostic procedures in some patients as well as optimize the preoperative triage process for those patients who will require therapeutic intervention
— id: 12253, year: 1997, vol: 828, page: 208, stat: Journal Article,

Ultrasonography-based triage for perimenopausal patients with abnormal uterine bleeding
Goldstein SR; Zeltser I; Horan CK; Snyder JR; Schwartz LB
1997 Jul;177(1):102-108, American journal of obstetrics & gynecology
OBJECTIVE: Abnormal perimenopausal bleeding is common and accounts for much medical and surgical intervention. This study was undertaken to evaluate an ultrasonography-based triage paradigm for perimenopausal patients with abnormal uterine bleeding. STUDY DESIGN: Four hundred thirty-three perimenopausal patients with abnormal uterine bleeding (either metrorrhagia, menorrhagia, or both) were evaluated. In lieu of undergoing a sampling procedure they were brought back on days 4 to 6 of the subsequent bleeding cycle, when the endometrium was expected to be its thinnest. If a distinct endometrial echo < or = 5 mm (double layer) was imaged by endovaginal ultrasonography, dysfunctional uterine bleeding was diagnosed. If a thickened endometrial echo > 5 mm or no endometrial echo was reliably visualized, a saline infusion sonohysterography was performed. If saline infusion sonohysterography revealed a symmetric single-layer endometrial thickness < 3 mm, dysfunctional uterine bleeding was diagnosed. If focal lesions were noted (polyps, submucous myomas, focal thickening), the patient was scheduled for curettage with hysteroscopy. If the endometrium was globally thickened, nondirected office biopsy was performed. RESULTS: A total of 341 patients (79%) had ultrasonographic evidence of no anatomic abnormality, and dysfunctional uterine bleeding requiring no further studies was diagnosed. Fifty-eight patients (13%) had focal polypold masses, all of which were removed hysteroscopically and confirmed pathologically. Twenty-two patients (5%) had submucous myomas; 10 patients (23%) had globally thickened endometrium on saline infusion sonohysterography, and then nondirected office sampling revealed hyperplasia in 5 and proliferation in 5. Two patients had technically inadequate saline infusion sonohysterography, and thus we proceeded to hysteroscopy with curettage. CONCLUSION: Nondirected office biopsy alone without imaging would have potentially missed the diagnosis of focal lesions such as polyps, submucous myomas, and focal hyperplasia in up to 80 patients (18%). Our clinical algorithm for perimenopausal patients with abnormal uterine bleeding used unenhanced endovaginal ultrasonography followed by saline infusion sonohysterography for selected patients. This approach allowed for no endometrial sampling, nondirected sampling, or directed sampling depending on whether the ultrasonography-based triage revealed no anatomic abnormalities, globally thickened endometrial tissue, or focal abnormalities, respectively
— id: 7156, year: 1997, vol: 177, page: 102, stat: Journal Article,

Alterations in steroid hormone receptors in the tamoxifen-treated endometrium
Schwartz LB; Krey L; Demopoulos R; Goldstein SR; Nachtigall LE; Mittal K
1997 Jan;176(1 Pt 1):129-137, American journal of obstetrics & gynecology
OBJECTIVE: Our purpose was to evaluate whether tamoxifen has estrogenic endometrial effects as defined by histologic study or alterations in steroid hormone receptor expression. STUDY DESIGN: Nineteen postmenopausal tamoxifen-treated breast cancer patients who also had endometrial sampling were identified from files in the Department of Obstetrics and Gynecology. To examine the subgroup of 15 polyps, age-matched, non-hormonally treated patients with polyps (n = 8) or atrophic endometria (n = 5) served as comparison groups. Proliferative (n = 3) and secretory (n = 5) endometria served as procedural controls. Immunohistochemical studies for steroid receptors (estrogen, progesterone) were performed. RESULTS: Glandular cell progesterone receptor was significantly increased and stromal cell estrogen receptor was significantly decreased in tamoxifen-treated versus atrophic endometria. Progesterone receptor staining was not significantly different in tamoxifen-treated versus control polyps, although staining was high in both groups. Stromal cell estrogen receptor staining was significantly reduced in tamoxifen-treated versus control polyps, although there were no histologic differences. Reduced stromal cell estrogen receptor and increased glandular cell progesterone receptor staining was found in all tamoxifen-treated endometria regardless of the diagnosis. CONCLUSION: The tamoxifen-associated changes in endometrial steroid receptors support an estrogenic effect that is independent of histologic diagnosis and duration of use. This may contribute to the pathogenesis of tamoxifen-associated polyps and carcinomas
— id: 7784, year: 1997, vol: 176, page: 129, stat: Journal Article,

Postmenopausal adnexal cysts: how clinical management has evolved
Goldstein SR
1996 Dec;175(6):1498-1501, American journal of obstetrics & gynecology
It has been 25 years since the introduction of the palpable postmenopausal ovary syndrome. As diagnostic imaging techniques have improved, small findings imaged in the adnexa were often handled as if they had been palpated. Clinical management was not made on any scientific basis. New endovaginal probes afford a degree of image magnification that is as if we are doing ultrasonography through a low-power microscope ('sonomicroscopy'). More recent additions of CA 125 measurement, color flow Doppler, and advanced endoscopic surgical techniques have come into the picture. This report attempts to describe an approach to postmenopausal cystic adnexal masses that synthesizes available information and techniques. It is designed to prevent unnecessary surgery and to prevent undue anxiety but not to miss or, at the least, unduly delay the diagnosis of ovarian cancer when it is, in fact, present
— id: 12454, year: 1996, vol: 175, page: 1498, stat: Journal Article,

Reprocessing of the vaginal probe between patients
Goldstein SR
1996 Feb;7(2):92-93, Ultrasound in obstetrics & gynecology
— id: 12652, year: 1996, vol: 7, page: 92, stat: Journal Article,

Saline infusion sonohysterography
Goldstein SR
1996 Mar;39(1):248-258, Clinical obstetrics & gynecology
Saline infusion sonography enhances endovaginal ultrasound examination of the uterine cavity. It is easily and rapidly performed at minimal cost. It is well tolerated by patients and virtually devoid of complications. It can prevent further invasive diagnostic procedures in some patients and optimize the preoperative triage process for those patients who will require therapeutic intervention
— id: 12640, year: 1996, vol: 39, page: 248, stat: Journal Article,

Correlation between karyotype and ultrasound findings in patients with failed early pregnancy
Goldstein SR; Kerenyi T; Scher J; Papp C
1996 Nov;8(5):314-317, Ultrasound in obstetrics & gynecology
The aim of this retrospetive study was to identify any consistent patterns between ultrasound findings in failed pregnancies and either normal or abnormal karyotypes. The study involved 102 women in whom the diagnosis of early pregnancy failure was made sonographically. The criteria for a failed pregnancy were: a gestational sac with a mean diameter of > 12 mm without a yolk sac; a yolk sac of > 6 mm mean diameter with or without abnormal morphology that ultimately failed to develop an embryonic structure; and an embryo with a crown--rump length (CRL) of > 5 mm without cardiac activity, or the loss of previously identified cardiac activity. All patients underwent elective dilatation and curettage (D & C) and products of conception were sent for karyotyping. Forty-four pregnancies (43%) had abnormal karyotypes. Of these, 33 (75%) were trisomies. The other 11 included four triploidies, one tetraploidy, two with monosomy X, and four others (unbalanced complement, isochromosome, terminal deletion and translocation). Fifty-eight pregnancies (57%) had normal karyotypes, of which 52 were 46,XX and six were 46,XY. The furthest sonographic anatomic landmark achieved did not differ with respect to karyotypic findings. An abnormal yolk sac was found in 10/58 cases (17.2%) with normal karyotypes and 8/44 cases (18.2%) with abnormal karyotypes. There were eight cases of trisomy 16, of which only two manifested an embryonic structure, but neither of which had cardiac activity; the largest was 4 mm. There were four cases of trisomy 22, of which three developed embryos with a CRL of > 10 mm with cardiac activity (11, 11 and 18 mm, respectively). In three cases of mosaicism, embryos developed cardiac activity, and were 9, 19 and 16 mm. Two cases of monosomy X had embryos of 14 and 24 mm. Only one out of five cases with multiple trisomies developed to a point at which any embryonic structure was identifiable on ultrasound examination. The ultrasound appearance of early pregnancy failure in terms of furthest anatomic landmark reached was not significantly different in cases with normal or abnormal karyotype. An abnormally enlarged yolk sac, presumably secondary to hydropic change, is a non-specific finding of failed pregnancy, and did not correlate with karyotypic abnormality (trisomy 22, mosaic, monosomy X) seem to develop further prior to embryonic demise than those with certain others (trisomy 16, multiple trisomies and unusual other variants
— id: 12481, year: 1996, vol: 8, page: 314, stat: Journal Article,

ULTRASONOGRAPHIC EVALUATION OF PATIENTS WITH ABNORMAL BLEEDING
GOLDSTEIN, SR
1995 OCT ;173(4):1351-1352, American journal of obstetrics & gynecology
— id: 86674, year: 1995, vol: 173, page: 1351, stat: Journal Article,

ULTRASONOGRAPHIC EVALUATION OF THE ENDOMETRIUM IN POSTMENOPAUSAL TAMOXIFEN-TREATED PATIENTS - REPLY
GOLDSTEIN, SR
1995 MAR ;172(3):1068-1068, American journal of obstetrics & gynecology
— id: 87394, year: 1995, vol: 172, page: 1068, stat: Journal Article,

UNUSUAL ULTRASONOGRAPHIC APPEARANCE OF UTERUS IN POSTMENOPAUSAL PATIENTS RECEIVING TAMOXIFEN - REPLY
GOLDSTEIN, SR
1995 FEB ;172(2):718-718, American journal of obstetrics & gynecology
— id: 87412, year: 1995, vol: 172, page: 718, stat: Journal Article,

UNTITLED - REPLY
GOLDSTEIN, SR; WOLFSON, R
1995 FEB ;14(2):99-100, Journal of ultrasound in medicine
— id: 87263, year: 1995, vol: 14, page: 99, stat: Journal Article,

Ultrasound in gynecology
Goldstein, Steven R.; Timor-Tritsch, Ilan E
New York : Churchill Livingstone, 1995,
— id: 517, year: 1995, vol: , page: , stat: ,

Embryonic death in early pregnancy: a new look at the first trimester
Goldstein SR
1994 Aug;84(2):294-297, Obstetrics & gynecology
OBJECTIVE: To examine the frequency of pregnancy loss following successful development of anatomical embryonic landmarks identified with endovaginal ultrasound. METHODS: Two hundred thirty-two women with positive urinary pregnancy tests and no antecedent history of vaginal bleeding had endovaginal sonography performed at the initial visit and at subsequent visits as indicated clinically. The presence of anatomical and embryonic structures (gestational sac, yolk sac, embryo) and cardiac activity was recorded. Patients were followed until delivery unless sonographic evidence of nonviability was seen or spontaneous loss occurred. RESULTS: Twenty-seven losses occurred during the embryonic period, four losses occurred in the fetal period, and there were 201 live births. If a gestational sac developed, subsequent loss of viability in the embryonic period occurred in 11.5%; loss rates were 8.5% with a yolk sac, 7.2% for an embryo up to 5 mm, 3.3% for an embryo of 6-10 mm, and 0.5% for an embryo larger than 10 mm. No pregnancies were lost between 8.5 and 14 menstrual weeks. The fetal loss rate after 14 weeks was 2.0%. CONCLUSIONS: The rate of early pregnancy loss decreases successively with gestational age and is virtually complete by the end of the embryonic period (70 days after onset of the last menstrual period). Subsequent pregnancy losses in the fetal period occur between 14 and 20 weeks. This pattern of early pregnancy death suggests a period of embryonic loss distinct from one of fetal loss. Based on these data, the physiologic significance of the traditional boundary of the first trimester as an appropriate dividing time line for early pregnancy may be questioned
— id: 12927, year: 1994, vol: 84, page: 294, stat: Journal Article,

Postmenopausal endometrial fluid collections revisited: look at the doughnut rather than the hole
Goldstein SR
1994 May;83(5 Pt 1):738-740, Obstetrics & gynecology
OBJECTIVE: To report 30 postmenopausal women and the thickness of the tissue surrounding an endometrial fluid collection seen on vaginal probe ultrasound. METHODS: During routine ultrasound-enhanced bimanual examination, nine postmenopausal women with unremarkable palpatory findings and no history of bleeding were found to have endometrial fluid collections. The patients were 9-24 years postmenopausal. All underwent prompt endometrial sampling. Each woman had some degree of cervical stenosis as judged by the operator. At curettage, all had scant tissue, which was reported by the pathologist as 'inactive endometrium.' RESULTS: Ultrasound scans on each patient were rereviewed, and it was found that the endometrium surrounding the fluid was uniformly 3 mm thick or less. Subsequently, 21 additional patients with small endometrial fluid collections have been seen. Eighteen of these had thin endometrium peripherally and were followed conservatively for 6-26 months. Six cases resolved and 12 remained unchanged. Three patients had a thickened heterogeneous endometrium peripheral to the fluid collection. In one, D&C was unsuccessful in two attempts because of cervical stenosis, and hysterectomy was performed. A 15-mm endometrial polyp was found. Two other patients with thickened endometrium surrounding the fluid had D&C, and hysteroscopy revealed simple hyperplasia without atypia. CONCLUSIONS. Normal atrophic postmenopausal endometrium in association with cervical stenosis can produce endometrial fluid collections, seen easily on vaginal probe ultrasound. If the endometrial tissue surrounding the fluid is thin (3 mm or less), the endometrium is invariably inactive and sampling is not necessary. If the peripheral endometrium is thicker than 3 mm, sampling is mandatory because the tissue cannot be expected to be invariably inactive and sampling is not necessary. If the peripheral endometrium is thicker than 3 mm, sampling is mandatory because the tissue cannot be expected to be inactive. Thus, the presence or amount of fluid is not as important as the thickness and character of the surrounding tissue
— id: 12969, year: 1994, vol: 83, page: 738, stat: Journal Article,

Sonography in early pregnancy failure
Goldstein SR
1994 Sep;37(3):681-692, Clinical obstetrics & gynecology
Early pregnancy can be best divided into embryonic and fetal periods (dividing line 70 days after last menstrual period), which more naturally reflect developmental changes, morphologic appearance, loss rates, and concerns about teratogens. Newer endovaginal probes and a better understanding of anatomic landmarks and expected growth rates can improve clinical management and patient counseling
— id: 12907, year: 1994, vol: 37, page: 681, stat: Journal Article,

Unusual ultrasonographic appearance of the uterus in patients receiving tamoxifen [see comments]
Goldstein SR
1994 Feb;170(2):447-451, American journal of obstetrics & gynecology
Tamoxifen is widely used as adjunctive therapy for patients with breast cancer and has been suggested as protection against the development of breast cancer in women at risk on the basis of heredity. It is a nonsteroidal estrogen antagonist, but like all antagonists it has some agonistic properties. Its administration should result in atrophic changes in the endometrium, but paradoxically some reports have found hyperplasia and even carcinomas developing prospectively in patients on tamoxifen therapy. Increasingly, endovaginal ultrasonography is being used for endometrial assessment in a wide variety of patients. This report is the first description of an unusual ultrasonographic finding in the uteri of some patients receiving tamoxifen. Initially believed to be endometrial in location, when viewed after fluid instillation (sonohysterogram) the heterogenous bizarre ultrasonographic appearance was actually found to represent small subendometrial sonolucencies in the proximal myometrium. Because none of these patients were clinically bleeding and all had inactive endometria on biopsy, it seems prudent not to overinterpret ultrasonography findings in patients receiving tamoxifen who have not had fluid-enhanced assessment
— id: 12999, year: 1994, vol: 170, page: 447, stat: Journal Article,

Use of ultrasonohysterography for triage of perimenopausal patients with unexplained uterine bleeding
Goldstein SR
1994 Feb;170(2):565-570, American journal of obstetrics & gynecology
OBJECTIVE: Concerns about pathologic anatomy in perimenopausal women with irregular vaginal bleeding have made invasive diagnostic procedures commonplace. This study evaluated the use of fluid instillation to enhance vaginal probe ultrasonographic examination of the endometrium in such patients. STUDY DESIGN: This was a prospective study of 21 women between 40 and 52 years old with irregular vaginal bleeding. On day 4 to 6 of the menstrual cycle a 5.3F Soules intrauterine insemination catheter (Cook ObGyn, Spencer, Ind.) was inserted, and under direct ultrasonographic examination sterile saline solution was slowly infused. If present, any polyp or submucous myoma was noted and the endometrial thickness surrounding the fluid was measured. Invasive endometrial sampling was then carried out. RESULTS: Of the 21 patients, 8 had obvious polypoid lesions and underwent triage for operative hysteroscopic removal. The pathology report confirmed benign polyps in all 8. Three patients had submucous myomas. Two had wire loop resectoscopic excision. The third, with a submucous myoma that extended to the serosal edge of the uterus, received expectant management. Nine patients had no obvious anatomic lesion and endometrial thickness of < or = 4 mm. Biopsy in all 9 of these patients revealed early proliferative endometrium. One patient had endometrial thickness of 8 mm; fractional curettage with hysterectomy revealed simple hyperplasia without atypia. CONCLUSIONS: Endometrial fluid instillation to enhance vaginal ultrasonography in perimenopausal women can reliably distinguish between patients with minimal tissue whose bleeding may be of anovulatory origin and best treated with hormonal therapy and those patients with significant amounts and type of tissue in need of formal curettage. Furthermore, polyps may be distinguished from submucous myomas, which allows appropriate preoperative triage for operative hysteroscopy when indicated and eliminates the need for diagnostic hysteroscopy
— id: 12998, year: 1994, vol: 170, page: 565, stat: Journal Article,

An updated protocol for abortion surveillance with ultrasound and immediate pathology [see comments]
Goldstein SR; Danon M; Watson C
1994 Jan;83(1):55-58, Obstetrics & gynecology
OBJECTIVE: To modify and improve a protocol for surveillance of patients presenting for routine elective abortion services. METHODS: Six hundred seventy-four women presenting for routine elective first-trimester abortions were studied. All were 84 or fewer days after the last menstrual period, had no history of bleeding, and had positive urine pregnancy tests. Each woman was scanned initially with an empty-bladder transabdominal technique. If no sac was seen, endovaginal ultrasonography was performed. All terminations had modified gross examination of tissue (3x magnification) as well as staining for microscopic analysis. RESULTS: Six hundred twelve patients (90.8%) demonstrated intrauterine gestations on transabdominal ultrasound, 595 of which were 12 or fewer weeks. Suction and sharp curettage and examination of tissue revealed products of conception in all. Seventeen subjects (2.5%) were found to be 13 or more weeks despite bimanual examinations and last menstrual period suggesting 12 or fewer weeks. Sixty-two patients had no sac seen on transabdominal ultrasound, 34 of whom had definitive intrauterine gestations on endovaginal ultrasound. Curettage revealed chorionic villi in all. Two had unruptured definitive ectopic pregnancies seen on endovaginal ultrasound. Twenty-one women with no sac seen on endovaginal ultrasound underwent curettage as the next step in triage; chorionic villi proved an intrauterine gestation in 17. The additional four had decidua only on pathology. Rising hCG levels in two of these four led to a diagnosis of ectopic pregnancy, whereas falling hCG levels in the other two led to a presumptive diagnosis of complete abortion, possibly tubal pregnancy in light of the lack of vaginal bleeding. CONCLUSION: Pre-abortion sonography eliminates inadvertent second-trimester cases, and immediate postoperative examination of curettage material expedites the diagnosis of ectopic pregnancy when present
— id: 13014, year: 1994, vol: 83, page: 55, stat: Journal Article,

Endovaginal ultrasonographic measurement of early embryonic size as a means of assessing gestational age [see comments]
Goldstein SR; Wolfson R
1994 Jan;13(1):27-31, Journal of ultrasound in medicine
Crown-rump length has consistently been found to be the most accurate method of determining gestational age in the first trimester. The original regression curve established by Robinson in 1973 with static arm scanners remains the one most widely employed. New endovaginal ultrasonographic probes afford a degree of detail that allows embryonic structures to be seen as soon as they are distinct from the yolk sac. Previously, measurements of very early embryonic structures have mistakenly been labeled crown-rump lengths. There has been widespread use of nomograms constructed from regression curves, where the bulk of the data were derived from small fetuses and then such curves extrapolated back to embryos of very small size. The purpose of this study was to establish a nomogram for gestational age assessment by measuring early embryos prior to the development of a 'crown' or 'rump.' This present study consisted of 143 patients. To be included they had to have had no history of any prior bleeding, and all were delivered of singleton infants within 2 weeks of their estimated delivery date by last menstrual period. All had a single early embryonic size measurement between 1 and 25 mm using high-frequency endovaginal probes. Regression analysis revealed a linear equation of Gestational age (days) = early embryonic size (mm) + 42 with a correlation coefficient r = 0.87; 95% confidence limit = +/- 3 days. We conclude that using high-frequency vaginal ultrasonographic probes and having a better understanding of embryonic anatomic stages allow for the construction of a nomogram of gestational age derived from measurements of early embryonic size prior to development of a crown-rump length
— id: 13042, year: 1994, vol: 13, page: 27, stat: Journal Article,

Conservative management of small postmenopausal cystic masses
Goldstein SR
1993 Jun;36(2):395-401, Clinical obstetrics & gynecology
— id: 13137, year: 1993, vol: 36, page: 395, stat: Journal Article,

Significance of cardiac activity on endovaginal ultrasound in very early embryos
Goldstein SR
1992 Oct;80(4):670-672, Obstetrics & gynecology
OBJECTIVE: To evaluate the significance of cardiac activity on endovaginal ultrasound in embryos up to 10 mm in size. METHODS: Ninety-six women with positive urinary pregnancy tests had vaginal probe ultrasound examinations at the first clinical visit. All had discernible embryos between 1-10 mm in greatest length. The presence or absence of discernible cardiac activity was recorded. None of the subjects had any antecedent bleeding. All were available for follow-up until delivery or completion of a failed pregnancy. RESULTS: Seventy-four women had cardiac activity present at the initial study and 22 did not. Eighty-one delivered healthy newborns and 15 had early pregnancy failure. All embryos that ultimately proved normal showed cardiac activity by the time they were 4 mm in size. However, absence of detectable cardiac activity in embryos of 3 mm or less was still associated with a 41% continuation rate. CONCLUSIONS: Cardiac activity is present in normal embryos before it can be detected on ultrasound. There are variations in the type and frequency of ultrasound equipment, maternal anatomical characteristics (obesity, coexisting fibroids, uterine version), and in the visual acuity of observers. Nevertheless, we conclude that in our hands, the absence of cardiac activity in embryos measuring 4 mm or more is reliably associated with embryonic death. In contrast, the lack of cardiac activity in embryos of 3 mm or less is nondiagnostic and may warrant follow-up study in 3-5 days
— id: 13418, year: 1992, vol: 80, page: 670, stat: Journal Article,

Embryonic ultrasonographic measurements: crown-rump length revisited [see comments]
Goldstein SR
1991 Sep;165(3):497-501, American journal of obstetrics & gynecology
New endovaginal probes will result in many investigators reexamining the crown-rump length data first generated with static arm and abdominal real-time scanners. As new tables are produced, only through better understanding of the anatomy of early embryos can we realize what we are actually seeing and measuring (or at least attempting to measure). Furthermore, as we try to correlate early embryonic size with gestational age, we realize that the crown-rump measurement is not applicable in principle or in nomenclature when the embryo is less than 18 mm long. When first seen, the embryo is relatively straight; a measurement of its size is best described as 'greatest length.' As the embryo curves into a C-shaped, tadpolelike structure, the greatest measurement along the long axis is actually a neck-rump measurement. Further unfolding of the head and regression of the tail finally allow an accurate crown-rump measurement (at about 18 mm) as we have used it for almost two decades. Early embryonic stages and characteristics are reviewed and methods of measurement of early embryonic size are explained
— id: 13914, year: 1991, vol: 165, page: 497, stat: Journal Article,

Use of endovaginal ultrasound in the overall gynecologic examination
Goldstein SR
1991 Dec;18(4):779-796, Obstetrics & gynecology clinics of North America
Endovaginal ultrasound scanning is not merely a subset of conventional ultrasonography as practiced today. It should not be reserved for the imaging specialist. Its unique characteristics allow its incorporation into the overall routine gynecologic examination
— id: 13822, year: 1991, vol: 18, page: 779, stat: Journal Article,

Endovaginal ultrasound
Goldstein, Steven R
New York : Wiley-Liss, c1991,
— id: 380, year: 1991, vol: , page: , stat: ,

Endometrial assessment by vaginal ultrasonography before endometrial sampling in patients with postmenopausal bleeding
Goldstein, S R; Nachtigall, M; Snyder, J R; Nachtigall, L
1990 Jul;163(1 Pt 1):119-123, American journal of obstetrics & gynecology
Endometrial sampling is the mainstay of management of the postmenopausal patient with uterine bleeding. Thirty women with postmenopausal bleeding were studied prospectively. Before endometrial sampling, a vaginal probe ultrasonographic examination was performed. Eleven patients demonstrated a thin 'pencil line' endometrial echo in which the maximum anteroposterior thickness on the long axis view was less than or equal to 5 mm. All eleven patients had minimal tissue obtained on biopsy and a pathology report of 'tissue insufficient for diagnosis.' Seventeen patients had an echogenic endometrium greater than or equal to 6 mm. Pathology reports of their samples revealed tissue insufficient for diagnosis (two cases), proliferative endometrium (six), secretory endometrium (three), hyperplastic endometrium (three), polyp (two), and endometrial cancer (one case). Two additional patients had no endometrial echo visualized because of associated myomas. These findings suggest (1) that the absence of significant endometrial tissue (echo less than or equal to 5 mm) on vaginal ultrasonography in cases with postmenopausal bleeding is uniformly associated with tissue insufficient for diagnosis, and (2) when endometrial thickness is greater than or equal to 6 mm the histologic diagnosis should be determined in the pathology laboratory
— id: 90915, year: 1990, vol: 163, page: 119, stat: Journal Article,

EARLY DETECTION OF PATHOLOGICAL PREGNANCY BY TRANSVAGINAL SONOGRAPHY
Goldstein, SR
1990 May;18(4):262-273, Journal of clinical ultrasound
— id: 32063, year: 1990, vol: 18, page: 262, stat: Journal Article,

EARLY-PREGNANCY FAILURE - APPROPRIATE TERMINOLOGY
GOLDSTEIN, SR
1990 SEP ;163(3):1093-1093, American journal of obstetrics & gynecology
— id: 98499, year: 1990, vol: 163, page: 1093, stat: Journal Article,

INCORPORATING ENDOVAGINAL ULTRASONOGRAPHY INTO THE OVERALL GYNECOLOGIC EXAMINATION
GOLDSTEIN, SR
1990 MAR ;162(3):625-632, American journal of obstetrics & gynecology
— id: 98510, year: 1990, vol: 162, page: 625, stat: Journal Article,

TRANSVAGINAL SONOGRAPHIC DETECTION OF THE PSEUDOGESTATIONAL SAC ASSOCIATED WITH ECTOPIC PREGNANCY
Goldstein, SR
1990 Nov;76(5):892-893, Obstetrics & gynecology
— id: 32037, year: 1990, vol: 76, page: 892, stat: Journal Article,

VAGINAL PROBE ULTRASONOGRAPHY AND ECTOPIC PREGNANCY
Goldstein, SR
1990 Sep;163(3):1099-1099, American journal of obstetrics & gynecology
— id: 32046, year: 1990, vol: 163, page: 1099, stat: Journal Article,

Transvaginal sonographic technique: targeted organ scanning without resorting to "planes"
Rottem, S; Thaler, I; Goldstein, S R; Timor-Tritsch, I E; Brandes, J M
1990 May;18(4):243-247, Journal of clinical ultrasound
The orientation of the sonographer performing a transvaginal scan is currently based on a concept of anatomical planes, which is customary in transabdominal sonography. We challenge this concept and propose a different approach altogether based on focusing on target organs rather than anatomic planes. The problem of orientation in transvaginal sonography stems from the following: (1) There is a very short distance between the relatively high-frequency transvaginal transducer-probe and the scanned area; a close-up image is generated encompassing a single organ or only part of it. (2) The scanning angle is initially perpendicular to that of abdominal sonography. (3) Transvaginal sonography is an endocavitary dynamic scanning technique. According to the experience in our department (30,000 examinations during the past 4 years) and in two other medical centers, best results from the transvaginal ultrasonographic examination are achieved when the operator searches for every specific organ as the main target, without resorting to pelvic 'planes.' The guidelines for targeted organ scanning and the associated change in orientation are reported together with the limitations. Targeted organ scanning without resorting to 'planes' helps the operator to resolve the problem of orientation during the transvaginal ultrasonographic examination, and to simplify the procedure to a great extent
— id: 76565, year: 1990, vol: 18, page: 243, stat: Journal Article,

The postmenopausal cystic adnexal mass: the potential role of ultrasound in conservative management
Goldstein SR; Subramanyam B; Snyder JR; Beller U; Raghavendra BN; Beckman EM
1989 Jan;73(1):8-10, Obstetrics & gynecology
Often ovarian cancer does not present clinically until the advanced stages. In the past, the presence of any cystic adnexal enlargement in postmenopausal women was an indication for surgical exploration. The ultrasound scans of 42 postmenopausal women with simple adnexal cysts were reviewed. We included only patients who were available for follow-up and who had cysts that were less than or equal to 5 cm in maximum diameter, unilocular (ie, without septations or solid components), and without ascites. Of these patients, 26 underwent prompt surgical exploration. All exhibited benign histopathology. In 16 patients, serial sonographic surveillance was performed every 3-6 months. Two of these patients had exploratory laparotomy at 6 and 9 months of observation; the first operation, for increasing size and septation, demonstrated a cystadenofibroma, and the second, for increasing pain, demonstrated a degenerating myoma. The remaining 14 patients were followed from 10-73 months without any change in size or character of the cyst. Small (less than 5 cm), unilocular postmenopausal cysts had a low incidence of malignant disease (0%) in this series of 28 surgical specimens. Therefore, serial ultrasound follow-up without surgical intervention may play a role in the clinical management of such patients
— id: 10804, year: 1989, vol: 73, page: 8, stat: Journal Article,

Estimation of nongravid uterine volume based on a nomogram of gravid uterine volume: its value in gynecologic uterine abnormalities
Goldstein SR; Horii SC; Snyder JR; Raghavendra BN; Subramanyam B
1988 Jul;72(1):86-90, Obstetrics & gynecology
To facilitate accurate and standard methods of reporting pathologic uterine corpus enlargement, we constructed a nomogram using the gravid uterine corpus volumes from five to 20 weeks' gestation in 186 patients. The volume was calculated by measuring the maximum length and anteroposterior and transverse diameters of the uterine corpus, and using the formula for the volume of a prolate ellipsoid: V = 0.52 X (L X AP X T). Clinicians can use the nomogram for better understanding in assessing uterine volume
— id: 11039, year: 1988, vol: 72, page: 86, stat: Journal Article,

Combined sonographic-pathologic surveillance in elective first-trimester termination of pregnancy
Goldstein SR; Snyder JR; Watson C; Danon M
1988 May;71(5):747-750, Obstetrics & gynecology
In this study, we attempted to develop a surveillance protocol for elective first-trimester termination to see whether unsuspected ectopic pregnancy could be detected earlier, and to identify those patients with unsuspected second-trimester pregnancies that could be terminated more safely in the hospital. Two hundred fifty consecutive patients requesting elective termination were studied prospectively. All were 12 weeks or less by last menstrual period, had positive urinary pregnancy tests, and had no history of vaginal bleeding. All patients had ultrasound screening before curettage. Immediately after curettage, a 'modified' gross pathologic examination (3X magnification) was also performed on unstained curettage material. The sonographic, operative, and pathologic findings were all correlated. Such screening identified four patients with unruptured ectopic pregnancies, who were operated on the same day as the curettage. In addition, four patients, who were actually in the second trimester but had inaccurate dates, were identified and referred to hospital for appropriate methods of termination. We conclude that such surveillance may reduce morbidity in elective terminations and more rapidly identify unsuspected ectopic pregnancies
— id: 11114, year: 1988, vol: 71, page: 747, stat: Journal Article,

Very early pregnancy detection with endovaginal ultrasound
Goldstein SR; Snyder JR; Watson C; Danon M
1988 Aug;72(2):200-204, Obstetrics & gynecology
There are many situations in which the earliest possible detection of an intrauterine pregnancy would enhance clinical management. Current radioimmunoassays for hCG can detect pregnancy as early as eight to 12 days post-conception. The ability to document an intrauterine pregnancy with ultrasound has lagged behind by two to three weeks. New high-frequency endovaginal transducers offer the promise of narrowing this gap. This study was undertaken prospectively on 235 patients all amenorrheic for seven weeks or less and requesting either pregnancy testing or termination. All had endovaginal ultrasound scans. We obtained hCG levels when no sac was seen or when the sac was less than 1.0 cm (initial experience revealed that all sacs over 1.0 cm were associated with hCG levels over 6000 mIU/mL) (International Reference Preparation). Ultrasound findings were correlated with pathology specimens and/or hCG levels where appropriate. Results indicated that normal pregnancies can be imaged when: 1) The sac is greater than 0.4 cm; 2) hCG is greater than 1025 mIU/mL (International Reference Preparation); and 3) the uterus is normal with a homogeneous echo pattern. This was not true in three of our cases with diffuse myomatous changes or a coexisting intrauterine device
— id: 11003, year: 1988, vol: 72, page: 200, stat: Journal Article,

Endovaginal ultrasound
Goldstein, Steven R
New York : A.R. Liss, c1988,
— id: 73, year: 1988, vol: , page: , stat: ,

Ratio of gestational sac volume to crown-rump length in early pregnancy
Goldstein, S R; Subramanyam, B R; Snyder, J R
1986 May;31(5):320-321, Journal of reproductive medicine
The sine qua non of fetal well-being in the first trimester is considered to be the presence of fetal cardiac activity. Despite fetal viability, some pregnancies might have a sac that is too large or small for the gestational age, even in the first trimester. As a first step in evaluating this hypothesis, a nomogram was constructed for the ratio of normal sac volume to crown-rump length
— id: 130687, year: 1986, vol: 31, page: 320, stat: Journal Article,

In vivo evaluation of intracellular pH and high-energy phosphate metabolites during regional myocardial ischemia in cats using 31P nuclear magnetic resonance
Stein PD; Goldstein S; Sabbah HN; Liu ZQ; Helpern JA; Ewing JR; Lakier JB; Chopp M; LaPenna WF; Welch KM
1986 Apr;3(2):262-269, Magnetic resonance in medicine
Phosphorus-31 nuclear magnetic resonance spectroscopy (31P NMR) was used to assess the temporal changes of high-energy phosphate metabolites in the region of acute myocardial ischemia of open-chest cats. Eight anesthetized cats were studied following ligation of the left anterior descending coronary artery. Creatine phosphate showed a 79 +/- 16% (mean +/- SD) reduction by 4 min after the onset of ischemia. Prominent qualitative reductions of the spectral peak of creatine phosphate occurred by 40 s after ischemia. Adenosine triphosphate measured under the beta spectral peak (beta-ATP) decreased 37 +/- 9% by 20-25 min after ligation of the left anterior descending coronary artery. These reductions developed more slowly and were of smaller magnitude than those of creatine phosphate. Intracellular pH decreased from 7.39 +/- 0.07 to 7.13 +/- 0.09 units by 40 s after ischemia. By 30 min, pH decreased to 6.07 +/- 0.40 units. The study shows, therefore, the temporal changes of high-energy phosphate metabolites during ischemia in localized regions of the myocardium of open-chest animals
— id: 67154, year: 1986, vol: 3, page: 262, stat: Journal Article,

Ultrasound diagnosis of interstitial pregnancy
Coady DJ; Snyder JR; Goldstein SR; Subramanyan BR
1985 Nov;85(11):655-656, New York state journal of medicine
— id: 22123, year: 1985, vol: 85, page: 655, stat: Journal Article,

Simplified loop ostomy fixation using rubber tubing
Goldstein S; Sohn N; Weinstein MA; Robbins RD
1984 Apr;158(4):375-376, Surgery, gynecology & obstetrics
This technique has simplified ostomy care and has helped reduce skin complications. The ready availability of rubber tubing in the operating room makes this technique quite practical
— id: 35943, year: 1984, vol: 158, page: 375, stat: Journal Article,

Subchorionic bleeding in threatened abortion: sonographic findings and significance
Goldstein, S R; Subramanyam, B R; Raghavendra, B N; Horii, S C; Hilton, S
1983 Nov;141(5):975-978, American journal of roentgenology
Fifty-six patients with clinical threatened abortion were evaluated by sonography. In six patients, fetal cardiac activity was absent at or beyond 9 weeks of gestation, and fetal death was confirmed in all six cases. In the other 50 patients, fetal cardiac activity was present at or beyond 9 weeks of gestation. In 10 (20%) of these 50 patients, subchorionic bleeding was present in various degrees, appearing sonographically as an extrachorionic crescentic anechoic or complex collection. The final outcome in the 50 patients with fetal cardiac activity was as follows: In the absence of subchorionic bleeding, 100% of the pregnancies progressed to term; in the presence of subchorionic bleeding the positive outcome was reduced to 80%. In addition to signs of fetal life on sonography, subchorionic bleeding is an important factor affecting the outcome of gestations in patients with clinical threatened abortion
— id: 124454, year: 1983, vol: 141, page: 975, stat: Journal Article,