Ospemifene, a non-oestrogen selective oestrogen receptor modulator for the treatment of vaginal dryness associated with postmenopausal vulvar and vaginal atrophy: A randomised, placebo-controlled, phase III trial

Abstract

Once-daily oral ospemifene 60 mg was effective for the treatment of VVA in postmenopausal women with vaginal dryness.

EMAS position statement: The ten point guide to the integral management of menopausal health

“…Evidence of efficacy of ospemifene is based on randomised controlled trials and long term safety data are available [30]. The approved indication in Europe is for 'treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy'.…”

Post-menopausal vulvovaginal atrophy — an overview of the current treatment options

“…The effectiveness of 60 mg/day ospemifene was assessed by Portman et al [36] in a randomised, placebo-controlled, phase III trial on 314 women, who reported vaginal dryness as the most bothersome symptom of VVA. There were 33.8% responders in the treatment group compared to 7.1% of patients receiving a placebo.…”

Update on management of genitourinary syndrome of menopause: A practical guide

“…Ospemifene is a selective estrogen receptor modulator (SERM) [31]. Several studies have shown efficacy [32][33][34][35][36][37][38]. A pivotal 12 week randomized trial showed that ospemifene was shown to be effective and well tolerated for the treatment of the symptoms of vaginal dryness and dyspareunia associated with vulvovaginal atrophy over and above the use of provided lubricants [32].Subsequent studies have confirmed efficacy and safety over 12 months.…”

“…A pivotal 12 week randomized trial showed that ospemifene was shown to be effective and well tolerated for the treatment of the symptoms of vaginal dryness and dyspareunia associated with vulvovaginal atrophy over and above the use of provided lubricants [32].Subsequent studies have confirmed efficacy and safety over 12 months. Hot flushes are the most common reported treatment related adverse events in about 7% of patients [34,37]. Endometrial safety was evaluated in six randomized, double-blind, placebo controlled, parallel-group studies lasting up to 52 weeks [33].…”