Archer DF, et al. - Researchers evaluated ospemifene regarding safety and efficacy in treating moderate to severe vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA). They randomized 631 postmenopausal women (aged 40-80 years) with VVA and moderate to severe vaginal dryness as their most bothersome symptom to daily oral ospemifene 60 mg [n = 316] or placebo [n = 315] in this 12-week, multicenter, double-blind phase 3 study. Significant improvement in the percentages of parabasal and superficial cells, vaginal pH, and severity of vaginal dryness severity was reported in correlation to ospemifene vs placebo at week 12; significant between-group differences were noted by week 4. Ospemifene vs placebo also led to significant improvement in secondary endpoints of dyspareunia, maturation value, and the Female Sexual Function Index. Furthermore, with ospemifene vs placebo, significantly more women responded or were satisfied at week 12. Findings thereby support the efficacy of and well tolerability to ospemifene for the treatment of moderate-to-severe vaginal dryness in postmenopausal women with VVA.