NCT01101841

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

A Phase 3, Twenty-Four Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Mesafem (Paroxetine Mesylate) Capsules in the Treatment of Vasomotor Symptoms Associated With Menopause

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 570 (actual)
• Sponsor: Noven Therapeutics · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause

Detailed description

The study is a 24-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg in subjects with moderate to severe postmenopausal VMS, defined as follows: 1. Moderate VMS: Sensation of heat with sweating, able to continue activity 2. Severe VMS: Sensation of heat with sweating, causing cessation of activity The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	Brisdelle (paroxetine mesylate)	Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.
DRUG	Placebo capsules	Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-09-01
• Completion: 2011-11-01
• First posted: 2010-04-12
• Last updated: 2015-10-15
• Results posted: 2014-04-21

Locations

32 sites across 1 country: United States