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Endometrial effects of lasofoxifene: Results from two phase 3 osteoporosis prevention trials [Meeting Abstract]
Goldstein, Steven R; Portman, David; Symons, James
ISI:000369888500061
ISSN: 1530-0374
CID: 1989362
Does purified Swedish pollen extract, a nonhormonal treatment for vasomotor symptoms, inhibit the CYP2D6 enzyme system?
Goldstein, Steven R; Espie, Marc; Druckmann, Rene
OBJECTIVE: Tamoxifen, used for treatment and chemoprevention of breast cancer, is converted to 4-hydroxy-tamoxifen and other metabolites by cytochrome P450 (CYP) enzymes. It can often initiate or exacerbate vasomotor symptoms (VMS). Selective serotonin reuptake inhibitors (SSRIs) have been prescribed for VMS in such participants in which estrogens are contraindicated. However, SSRIs are strong CYP2D6 inhibitors and can reduce the efficacy of tamoxifen. A nonhormonal purified Swedish pollen extract (Relizen is also prescribed in other countries under different registered trade names: Serelys, Femal, Femalen), has shown efficacy versus placebo in treating VMS in a randomized, double-blind controlled trial. The objective of this study was to evaluate the in vitro effects of purified Swedish pollen extract on the CYP2D6 enzyme. METHODS: PE-F/S, the powder form of purified Swedish pollen extract, contains 75% pollen/pistil extract P182 and 25% pollen extract GCFem. It was tested for its potential to inhibit the human CYP isoenzyme, CYP2D6, in pooled human liver microsomes. Quinidine, a known inhibitor of CYP2D6, was used as a reference. Concentrations of purified Swedish pollen extract ranged from 1.65 to 400 mug/mL, approximately five times the recommended daily dose for VMS. RESULTS: Inhibition of CYP2D6 with purified Swedish pollen extract was negligible at all concentrations and ranged from -6.53% to 10.67%. Inhibition of CYP2D6 enzyme with Quinidine increased in a linear dose-related fashion from -7.07% at 2.06 nM to 84.05% at 500 nM. CONCLUSIONS: Purified Swedish pollen extract is a nonhormonal treatment of VMS that does not show inhibition of the CYP2D6 enzyme. This may have important clinical utility for women using tamoxifen for breast cancer treatment or chemoprevention who experience VMS.
PMID: 26325084
ISSN: 1530-0374
CID: 1841282
Terms, definitions and measurements to describe sonographic features of myometrium and uterine masses: a consensus opinion from the Morphological Uterus Sonographic Assessment (MUSA) group
Van den Bosch, T; Dueholm, M; Leone, F P G; Valentin, L; Rasmussen, C K; Votino, A; Van Schoubroeck, D; Landolfo, C; Installe, A J F; Guerriero, S; Exacoustos, C; Gordts, S; Benacerraf, B; D'Hooghe, T; De Moor, B; Brolmann, H; Goldstein, S; Epstein, E; Bourne, T; Timmerman, D
The MUSA (Morphological Uterus Sonographic Assessment) statement is a consensus statement on terms, definitions and measurements that may be used to describe and report the sonographic features of the myometrium using gray-scale sonography, color/power Doppler and three-dimensional ultrasound imaging. The terms and definitions described may form the basis for prospective studies to predict the risk of different myometrial pathologies, based on their ultrasound appearance, and thus should be relevant for the clinician in daily practice and for clinical research. The sonographic features and use of terminology for describing the two most common myometrial lesions (fibroids and adenomyosis) and uterine smooth muscle tumors are presented
PMID: 25652685
ISSN: 1469-0705
CID: 1777622
Not all SERMs are created equal: chapter 2
Goldstein, Steven R
PMID: 26102533
ISSN: 1530-0374
CID: 1698162
Algorithm and mobile app for menopausal symptom management and hormonal/non-hormonal therapy decision making: a clinical decision-support tool from The North American Menopause Society [Editorial]
Manson, JoAnn E; Ames, Jeffrey M; Shapiro, Marla; Gass, Margery L S; Shifren, Jan L; Stuenkel, Cynthia A; Pinkerton, JoAnn V; Kaunitz, Andrew M; Pace, Diane T; Kagan, Risa; Schnatz, Peter F; Kingsberg, Sheryl A; Liu, James H; Joffe, Hadine; Richard-Davis, Gloria; Goldstein, Steven R; Schiff, Isaac; Utian, Wulf H
PMID: 25314150
ISSN: 1530-0374
CID: 1606372
Consider ultrasound first for imaging the female pelvis
Benacerraf, Beryl R; Abuhamad, Alfred Z; Bromley, Bryann; Goldstein, Steven R; Groszmann, Yvette; Shipp, Thomas D; Timor-Tritsch, Ilan E
Ultrasound technology has evolved dramatically in recent years and now includes applications such as 3-dimensional volume imaging, real-time evaluation of pelvic organs (simultaneous with the physical examination), and Doppler blood flow mapping without the need for contrast, which makes ultrasound imaging unique for imaging the female pelvis. Among the many cross-sectional imaging techniques, we should use the most informative, less invasive, and less expensive modality to avoid radiation when possible. Hence, ultrasound imaging should be the first imaging modality used in women with pelvic symptoms.
PMID: 25841638
ISSN: 1097-6868
CID: 1602672
Letter to the editor [Letter]
Goldstein, Steven R
PMID: 25668309
ISSN: 1530-0374
CID: 1520672
Endometrial safety of ospemifene: results of the phase 2/3 clinical development program
Constantine, Ginger D; Goldstein, Steven R; Archer, David F
OBJECTIVE: This study aims to assess the endometrial safety of ospemifene based on phase 2/3 clinical trials of postmenopausal women with up to 52 weeks of exposure to ospemifene 60 mg/day versus placebo. METHODS: Endometrial safety was evaluated in a development program of six randomized, double-blind, placebo-controlled, parallel-group studies of postmenopausal women aged between 40 and 80 years who had vulvar and vaginal atrophy. Participants were randomized 1:1 to ospemifene 60 mg/day or placebo in one 6-week trial and three 12-week trials; one of the 12-week trials had a 40-week extension study. In a separate 52-week trial, women were randomized 6:1 to ospemifene 60 mg/day or placebo. Endometrial safety was assessed by endometrial histology (biopsy), transvaginal ultrasound, and gynecologic examination. RESULTS: In these trials, 1,242 women who received ospemifene 60 mg/day and 924 women who received placebo were evaluable for safety. Endometrial hyperplasia occurred in less than 1% of women treated with ospemifene; no endometrial cancer was reported. The mean (SD) increase in endometrial thickness among women treated with ospemifene was 0.51 (1.54) mm at 12 weeks, 0.56 (1.61) mm at 6 months, and 0.81 (1.54) mm at 12 months. Women who received placebo had a mean (SD) increase of 0.07 (1.23) mm at 12 months. CONCLUSIONS: These clinical trial data indicate that up to 52 weeks of treatment with oral ospemifene 60 mg/day was safe for the endometrium. There was no increase in the incidence of endometrial cancer or hyperplasia among postmenopausal women treated with ospemifene compared with placebo.
PMCID:4274342
PMID: 24977459
ISSN: 1072-3714
CID: 1437002
Cystadenofibromas: Can transvaginal ultrasound appearance reduce some surgical interventions?
Goldstein, Steven R; Timor-Tritsch, Ilan E; Monteagudo, Ana; Monda, Susan; Popiolek, Dorota
PURPOSE: Cystadenofibromas are benign ovarian neoplasms. Their most typical features on sonography (US) are unilocular cysts with small, shadowing hyperechoic, solid papillae without internal vascularity. In the past, they were virtually always surgically removed to exclude malignancy. This study was undertaken to review the sonographic appearances of benign cystadenomas. METHODS: We retrospectively reviewed the transvaginal US studies of 32 cases of pathologically proven ovarian cystadenofibromas. RESULTS: Twenty-two of the tumors presented as unilocular cystic structures with one or more solid, hyperechoic, shadowing, mural nodules with no discernible blood flow projecting from the inner cyst wall. Ten lesions were multiloculated with multiple small solid areas, with scant or no blood vessels. CONCLUSIONS: Cystadenofibromas do not always have a classic appearance on transvaginal US and color Doppler imaging. In our series, however, the majority (69%) presented as unilocular cysts with one or more small solid, avascular projections from the inner cyst wall. These features had 100% reliability for a diagnosis of benign cystadenofibroma in this small series. Further study is necessary to confirm the reliability of this finding for benign cystadenofibroma, thus possibly avoiding or minimizing any surgical exploration. (c) 2014 Wiley Periodicals, Inc. J Clin Ultrasound, 2014.
PMID: 25271400
ISSN: 0091-2751
CID: 1282952
Ovarian conservation at the time of hysterectomy for benign disease: where is the pendulum now? [Comment]
Goldstein, Steven R
PMID: 25399702
ISSN: 1369-7137
CID: 1422912