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

Wyeth is now a wholly owned subsidiary of Pfizer0 sites450 target enrollmentJune 2006

ConditionsMenopause Vasomotor System

DrugsDesvenlafaxine succinate sustained-release (DVS SR)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Menopause
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 450
Primary Endpoint: The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

February 2007

Last Updated

18 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
•Body Mass Index (BMI) less than or equal to 40 kg/m2
•Other inclusions apply.

Exclusion Criteria

•Hypersensitivity to Venlafaxine
•Myocardial infarction and/or unstable angina within 6 months of screening
•History of seizure disorder
•Other exclusions apply.

Outcomes

Primary Outcomes

The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.

Secondary Outcomes

The number of awakenings due to VMS and the total mood disturbance score (Profile of Mood States [POMS]).
The scores on the Greene Climacteric Scale (GCS), the Visual Analog Scale-Pain Intensity (VAS-PI), and the Satisfaction Survey (SS).