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

This study has been completed.

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00256685
  Purpose

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.


Condition Intervention Phase
Menopause
Hot Flashes
Sleep Disorders
Drug: DVS-233 SR
Phase III

MedlinePlus related topics:   Menopause    Sleep Disorders   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Further study details as provided by Wyeth:

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

Estimated Enrollment:   568
Study Start Date:   September 2004
Estimated Study Completion Date:   July 2005

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Exclusion Criteria:

  • Hypersensitivity to Venlafaxine
  • History of seizure disorder
  • History of myocardial infarction or unstable angina within 6 months

Other exclusions apply.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256685

Sponsors and Collaborators
Wyeth

Investigators
Study Director:     Medical Monitor     Wyeth    
  More Information

Study ID Numbers:   3151A2-319
First Received:   November 17, 2005
Last Updated:   May 17, 2006
ClinicalTrials.gov Identifier:   NCT00256685
Health Authority:   United States: Food and Drug Administration

Keywords provided by Wyeth:
Menopause  

Study placed in the following topic categories:
Signs and Symptoms
Mental Disorders
Hot Flashes
Neurologic Manifestations
Sleep Disorders
Menopause

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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