NCT00369434

Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women

A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of DVS SR for Treatment of Vasomotor Symptoms Associated With Menopause

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of postmenopausal women.

Detailed description

To assess the efficacy and safety of 100 mg and 150 mg of DVS SR in comparison to placebo for the treatment of moderate to severe VMS associated with menopause, as well as additional outcome indicators such as sleep disruptions, overall climacteric symptoms, mood changes, somatic symptoms, and overall satisfaction with DVS SR in postmenopausal women.

Conditions

• Menopause
• Vasomotor System

Interventions

Type	Name	Description
DRUG	Desvenlafaxine succinate sustained-release (DVS SR)

Timeline

• Start date: 2006-06-01
• Completion: 2007-02-01
• First posted: 2006-08-29
• Last updated: 2007-06-01

Locations

34 sites across 1 country: United States