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Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause

Primary Purpose

Menopause, Hot Flashes, Sleep Disorders

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

DVS-233 SR

About this trial

This is an interventional treatment trial for Menopause focused on measuring Menopause

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. Exclusion Criteria: Hypersensitivity to Venlafaxine History of seizure disorder History of myocardial infarction or unstable angina within 6 months Other exclusions apply.

Sites / Locations

Outcomes

Primary Outcome Measures

Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12

Secondary Outcome Measures

Sleep, mood

Full Information

NCT ID

NCT00256685

First Posted

November 17, 2005

Last Updated

May 17, 2006

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00256685

Brief Title

Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2006

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menopause, Hot Flashes, Sleep Disorders

Keywords

Menopause

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

568 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

DVS-233 SR

Primary Outcome Measure Information:

Title

Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12

Secondary Outcome Measure Information:

Title

Sleep, mood

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

0 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause

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