NCT01361308

Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)

A Phase 3, Twelve-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: 614 (actual)
• Sponsor: Noven Therapeutics · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety \& efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause.

Detailed description

This is 12-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg and placebo capsules in subjects with moderate to severe postmenopausal 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 The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

Conditions

• Postmenopausal Symptoms

Interventions

Type	Name	Description
DRUG	Brisdelle (paroxetine mesylate)	Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
DRUG	Placebo capsules	Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2011-05-26
• Last updated: 2015-10-15
• Results posted: 2014-05-20

Locations

74 sites across 1 country: United States