ORIGINAL RESEARCH—FSD PHARMACOTHERAPY
The Efficacy and Safety of Ospemifene in Treating Dyspareunia Associated with Postmenopausal Vulvar and Vaginal Atrophy: A Systematic Review and Meta-Analysis
Article first published online: 20 NOV 2013
© 2013 International Society for Sexual Medicine
The Journal of Sexual Medicine
Volume 11, Issue 2, pages 487–497, February 2014
How to Cite
Cui, Y., Zong, H., Yan, H., Li, N. and Zhang, Y. (2014), The Efficacy and Safety of Ospemifene in Treating Dyspareunia Associated with Postmenopausal Vulvar and Vaginal Atrophy: A Systematic Review and Meta-Analysis. Journal of Sexual Medicine, 11: 487–497. doi: 10.1111/jsm.12377
- Issue published online: 27 JAN 2014
- Article first published online: 20 NOV 2013
- Sexual Pain;
- Vulvovaginal Atrophy;
- Randomized Controlled Trial
Ospemifene, a novel selective estrogen receptor modulator, has been developed for the treatment of vulvovaginal atrophy and dyspareunia in postmenopausal women.
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.
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.
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.
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.