094 Phase III Study Evaluating Efficacy and Safety of Ospemifene in Menopausal Women with Moderate to Severe Vaginal Dryness: Overall Patient Satisfaction with Treatment

Abstract

Genitourinary syndrome of menopause (GMS), comprising vulvovaginal atrophy (VVA), impacts the health and quality of life of postmenopausal women. Genital symptoms of VVA include dyspareunia and vaginal dryness as most bothersome symptoms (MBS) which over time lead to sexual dysfunction and emotional distress. This condition continues to be underdiagnosed, is characterized by poor patient satisfaction towards increasingly available treatments, and remains an area of unmet need. The objective of this study was to evaluate the safety and efficacy of ospemifene, an oral, selective estrogen receptor modulator and nonhormonal option for the treatment of vaginal dryness as the MBS of postmenopausal women with VVA. The proportion of responders and overall patient satisfaction were evaluated as secondary endpoints. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study assessed the efficacy and safety of ospemifene in menopausal women with vaginal dryness as MBS of VVA. Eligible subjects were postmenopausal, age 40-80 with moderate to severe vaginal dryness as a self-reported MBS. Subjects were randomized (1:1) to ospemifene 60 mg once daily or placebo for 12 weeks. Secondary endpoints included change from baseline at 4, 8 and 12 weeks in: 1) Maturation Value (MV) calculated from the percentages of superficial, intermediate and parabasal cells; 2) Proportion of responders, defined as a composite of primary efficacy endpoints: specified degree of improvements in MV, vaginal pH and severity of dryness; 3) Female sexual function index (FSFI), a total score derived from a computational formula integrating individual domain scores; 4) Overall patient satisfaction evaluated using an eDiary and summarized weekly for 12 weeks for each treatment group.