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Keywords:

  • Ospemifene;
  • Dyspareunia;
  • Sexual Pain;
  • Vulvovaginal Atrophy;
  • Meta-Analysis;
  • Randomized Controlled Trial

Abstract

Introduction

Ospemifene, a novel selective estrogen receptor modulator, has been developed for the treatment of vulvovaginal atrophy and dyspareunia in postmenopausal women.

Aim

We carried out a systematic review and meta-analysis to assess the efficacy and safety of the drug for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy.

Methods

A literature review was performed to identify all published randomized double-blind, placebo-controlled trials of ospemifene for the treatment of vulvovaginal atrophy and dyspareunia. The search included the following databases: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated. A systematic review and meta-analysis was conducted.

Main Outcome Measures

Six publications involving a total of 1,772 patients were used in the analysis, including three randomized controlled trials (RCTs) that were short-term (12 weeks) comparisons of ospemifene with placebo and three RCTs that were long-term (1 year) comparisons of ospemifene with placebo.

Results

For the comparison of short-term ospemifene with placebo, parabasal cells (the standardized mean difference [SMD] = −37.5, 95% confidence interval [CI] = −41.83 to −33.17, P < 0.00001), superficial cells (SMD = 9.24, 95% CI = 7.70 to 10.79, P < 0.00001), vaginal PH (SMD = −0.89, 95% CI = −0.98 to −0.80, P = 0.00001), and dyspareunia (SMD = −0.37, 95% CI = −0.43 to −0.30, P = 0.00001) indicated that ospemifene was more effective than the placebo. For the comparison of long-term ospemifene with placebo, endometrial thickness (SMD = 0.90, 95% CI = 0.58 to 1.23, P = 0.00001), treatment emergent adverse event, discontinuations due to adverse event, and serious adverse event indicated that ospemifene was generally safe.

Conclusions

This meta-analysis indicates that ospemifene to be an effective and safe treatment for dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Cui Y, Zong HT, Yan HL, Li N, and Zhang Y. Treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy: A systematic review and meta-analysis. J Sex Med 2014;11:487–497.