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

Abstract

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. 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).