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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00369434
First received: August 25, 2006
Last updated: May 31, 2007
Last verified: May 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Menopause
Vasomotor System
 Drug: Desvenlafaxine succinate sustained-release (DVS 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 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

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

Primary Outcome Measures:
  • The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 450
Study Start Date: June 2006
Study Completion Date: February 2007
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369434

  Show 34 Study Locations
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: NCT00369434     History of Changes
Other Study ID Numbers: 3151A2-337
Study First Received: August 25, 2006
Last Updated: May 31, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
O-desmethylvenlafaxine
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013