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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00256685
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : May 19, 2006
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Menopause Hot Flashes Sleep Disorders Drug: DVS-233 SR Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 568 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : September 2004
Study Completion Date : July 2005
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12

Secondary Outcome Measures :
  1. Sleep, mood

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256685


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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ClinicalTrials.gov Identifier: NCT00256685    
Other Study ID Numbers: 3151A2-319
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: May 19, 2006
Last Verified: May 2006
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Menopause
Additional relevant MeSH terms:
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Sleep Wake Disorders
Hot Flashes
Nervous System Diseases
Neurologic Manifestations
Mental Disorders