Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause

• Status: Completed
• Trial end date: 2009-06-01

Summary

This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (VMS), defined as follows:

• Moderate VMS: Sensation of heat with sweating, able to continue activity

• Severe VMS: Sensation of heat with sweating, causing cessation of activity

• Phase: Phase 2

Details

• Lead Sponsor: Noven Therapeutics
• Treatments: Paroxetine