NCT00683800

Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women

A Double-Blind, Randomized, Placebo-Controlled Study Assessing The Safety And Efficacy Of DVS SR For The Treatment Of Vasomotor Symptoms Associated With Menopause

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,186 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) in menopausal women.

Conditions

• Vasomotor Symptoms

Interventions

Type	Name	Description
DRUG	desvenlafaxine succinate (DVS) SR	Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days.
DRUG	Placebo	Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-05-23
• Last updated: 2011-08-17
• Results posted: 2011-08-17

Locations

121 sites across 2 countries: United States, Canada