Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause
May 17, 2006 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
568
Phase
- Phase 3
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
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
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 |
|---|
|
Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Sleep, mood
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
September 1, 2004
Study Completion
July 1, 2005
Study Registration Dates
First Submitted
November 17, 2005
First Submitted That Met QC Criteria
November 17, 2005
First Posted (Estimate)
November 21, 2005
Study Record Updates
Last Update Posted (Estimate)
May 19, 2006
Last Update Submitted That Met QC Criteria
May 17, 2006
Last Verified
May 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3151A2-319
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.