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Pilot prospective vulvoscopic study examining changes to the vulva, vestibule, and vagina in women with genitourinary syndrome of menopause taking ospemifene

Goldstein, SW1; Winter, AG2; Goldstein, I3

1: San Diego Sexual Medicine, United States; 2: San Diego Sexual Medicine, USA; 3: Alvarado Hospital

Objectives: Current government-approved treatments for genitourinary symptoms of menopause (GSM) are based on treatment of the atrophied vagina, with no attention to the health of the vestibule. Ospemifene, an oral selective estrogen receptor modifier (SERM) approved for treatment of mild to moderate dyspareunia, demonstrated improvement in pain scores and vaginal epithelial cell characteristics in published clinical trial data. The objective of this study was to prospectively study changes to the vulva, vestibule and vaginal region using vulvoscopic examination.

Materials and Methods: Post-menopausal women with dyspareunia were provided 60 mg daily ospemifene for 20 weeks. Vulvoscopy with photography was performed at screening and completion of therapy. Using pre-set likert scales, photographs were rated by a single reviewer for labia majora resorption, labia minora resorption, clitoral atrophy, urethral meatal prolapse, introital stenosis, pallor, erythema, mucosa inflammation, loss of vaginal ruggation, and anterior vaginal wall atrophy. Findings were correlated to subject reported pain scores (Q-tip test and subject diary). Scores were compared pre-and post intervention using Wilcoxon signed-rank test (Stata v13.1).

Results: 9 of the intended 10 subjects completed all visits and were included in the analysis. Age was 57±4.6 years, time since menopause 10.2±6.3 years, and BMI 26.6±5.1. Median estradiol, FSH, and LH values at enrollment were 21 pg/mL [IQR 7.5-27], 93 mIU/mL [IQR 72-96], and 40 mIU/mL [IQR 23-48], respectively. Urethral meatal prolapse, introital stenosis, pallor, erythema, mucosal inflammation, ruggation loss, and anterior wall atrophy diminished over the course of therapy (p<0.05 for all). Labial resorption and clitoral atrophy remained the same. Total pain score during Q-tip testing decreased from 11[IQR 10-16] to 1 [IQR 0-3] at end of study. The number of sexual events increased, rates of pain during foreplay and intercourse decreased, and use of lubricant decreased at study completion based on quantitative diary analysis (p<0.05).

Conclusions: Ospemifene 60mg daily for 20 weeks demonstrated improvement in physical examination findings in post-menopausal women with GSM, as documented on vulvoscopic photography in this pilot prospective study. Vulvoscopic changes were consistent with improvements in subject-reported pain and sexual function.


Work supported by industry: yes, by Shionogi (industry funding only - investigator initiated and executed study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

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