Female sexual function improved with ospemifene in postmenopausal women with vulvar and vaginal atrophy: results of a randomized, placebo-controlled trial

TLDR

Ospemifene is a selective estrogen receptor modulator approved for treating dyspareunia caused by vulvar and vaginal atrophy, a condition that often co‑occurs with female sexual dysfunction in postmenopausal women. This study evaluates the effect of daily 60 mg ospemifene on female sexual dysfunction as measured by the Female Sexual Function Index in postmenopausal women with VVA. A phase‑3, randomized, double‑blind, 12‑week trial enrolled 919 women and compared ospemifene to placebo, assessing changes in FSFI total and domain scores and serum hormone levels. Ospemifene produced a significantly greater improvement in FSFI total score versus placebo at week 4 (p < 0.001) and week 12, with all domains showing significant gains and hormone changes being minor and unrelated to sexual function. Primary data were published previously.

Abstract

Background Ospemifene is a non-estrogen, tissue selective estrogen receptor agonist/antagonist, or selective estrogen receptor modulator, recently approved for the treatment of dyspareunia, a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Postmenopausal dyspareunia is often associated with female sexual dysfunction (FSD). In this report, we present data that demonstrate the effect of ospemifene 60 mg/day on FSD assessed by the Female Sexual Function Index (FSFI), a widely used tool with six domains (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain).Methods A phase-3, randomized, double-blind, 12-week trial (n = 919) compared the efficacy and safety of oral ospemifene 60 mg/day vs. placebo in postmenopausal women with VVA in two strata based on self-reported, most bothersome symptom of either dyspareunia or dryness. Primary data were published previously. We report herein pre-specified secondary efficacy endpoints analyses, including changes from baseline to Weeks 4 and 12 for FSFI total and domain scores as well as serum hormone levels.Results Ospemifene 60 mg/day demonstrated a significantly greater FSFI total score improvement vs. placebo at Week 4 (p < 0.001). Improvement in FSFI scores continued to Week 12 (p < 0.001). At Week 4, the FSFI domains of Sexual Pain, Arousal, and Desire were significantly improved with ospemifene vs. placebo; at Week 12, improvements in all domains were significant (p < 0.05). Changes in serum hormones were minor and uncorrelated with changes in sexual functioning.Conclusion In a large, randomized, double-blind, placebo-controlled trial, ospemifene 60 mg/day significantly improved FSD in women with VVA. Consistent effects across FSFI domains were observed.