Ospemifene's effect on vasomotor symptoms: a post hoc analysis of phase 2 and 3 clinical data

Objective: To examine the effect of ospemifene 60 mg/d on vasomotor symptoms in postmenopausal women using clinical safety and efficacy data from five phase 2 and 3 studies.
Methods: The incidence of hot flush treatment-emergent adverse events (TEAEs) was compiled from five randomized, placebo-controlled clinical studies; baseline parameters associated with hot flush incidence were also identified. Ospemifene's effects on the frequency and severity of hot flushes were evaluated in a previously unpublished, 6-week, placebo-controlled study.
Results: Analysis of pooled hot flush TEAE data for 2,166 women showed an incidence of hot flush of 8.5% for ospemifene and 3.2% for placebo (P 

Source: Menopause - August 26, 2016 Category: OBGYN Tags: Original Articles Source Type: research