The clinical relevance of the effect of ospemifene on symptoms of vulvar and vaginal atrophy.

ABSTRACT:

Objectives

To explore clinically relevant differences in severity of vulvar and vaginal atrophy (VVA) in postmenopausal women treated with ospemifene compared with placebo.

Methods

Analysis of two multicenter, randomized, double-blind, 12-week phase-III studies in postmenopausal women (40-80 years, with VVA, treated with ospemifene 60 mg/day or placebo (Study 310 and Study 821)). Severity of vaginal dryness and dyspareunia were evaluated using a four-point scoring system and clinically relevant differences between ospemifene and placebo were analyzed and are presented as improvement (reduction in ≥ 1 unit on four-point scoring system), substantial improvement (reduction in 2-3 units on four-point scoring system) and relief (severity score of mild/none after 12 weeks).

Res

SUBMITTER: Nappi RE 

PROVIDER: S-EPMC4438339 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature