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

May 31, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Desvenlafaxine succinate sustained-release (DVS SR)

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.

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Montgomery, Alabama, United States, 36106
- Arizona
  - Peoria, Arizona, United States, 85381
- California
  - Upland, California, United States, 91786
- Colorado
  - Colorado Springs, Colorado, United States, 80910
- Florida
  - Brooksville, Florida, United States, 34613
  - Inverness, Florida, United States, 34452
  - Miami, Florida, United States, 33143
  - New Port Richey, Florida, United States, 34652
  - Ocala, Florida, United States, 34471
  - St. Petersburg, Florida, United States, 33709
  - Tampa, Florida, United States, 33606
- Georgia
  - Decatur, Georgia, United States, 30033
  - Savannah, Georgia, United States, 31406
- Idaho
  - Boise, Idaho, United States, 83702
  - Idaho Falls, Idaho, United States, 83404
- Kansas
  - Overland Park, Kansas, United States, 66210
- Kentucky
  - Louisville, Kentucky, United States, 40291
- Maine
  - Portland, Maine, United States, 04102
- Maryland
  - Rockville, Maryland, United States, 20852
- Montana
  - Billings, Montana, United States, 59102
- Nevada
  - Las Vegas, Nevada, United States, 89146
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
- North Carolina
  - Winston-Salem, North Carolina, United States, 27103
- North Dakota
  - Bismark, North Dakota, United States, 58501
  - Fargo, North Dakota, United States, 58104
- Ohio
  - Cincinnati, Ohio, United States, 45267-0457
- Oregon
  - Eugene, Oregon, United States, 97401
- Pennsylvania
  - Erie, Pennsylvania, United States, 16502
  - Philadelphia, Pennsylvania, United States, 19114
  - Wexford, Pennsylvania, United States, 15090
- South Carolina
  - Hilton Head Island, South Carolina, United States, 29926
- Utah
  - Midvale, Utah, United States, 84047
- Virginia
  - Norfolk, Virginia, United States, 23507
  - Richmond, Virginia, United States, 23294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

August 25, 2006

First Submitted That Met QC Criteria

August 25, 2006

First Posted (Estimate)

August 29, 2006

Study Record Updates

Last Update Posted (Estimate)

June 1, 2007

Last Update Submitted That Met QC Criteria

May 31, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

3151A2-337

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.