A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Wyeth is now a wholly owned subsidiary of Pfizer0 sites568 target enrollmentSeptember 2004

ConditionsMenopause Hot Flashes Sleep Disorders

DrugsDVS-233 SR

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Menopause
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 568
Primary Endpoint: Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with menopause, and also to assess the effects of DVS on sleep parameters and health outcomes indicators.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

July 2005

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

Inclusion Criteria

•Generally healthy, postmenopausal women who seek treatment for hot flushes
•Minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening
•Body Mass Index (BMI) less than or equal to 40 kg/m2
•Other inclusions apply.