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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00256685
First received: November 17, 2005
Last updated: May 17, 2006
Last verified: May 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Menopause

Additional relevant MeSH terms:
Parasomnias
Sleep Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 19, 2014