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.