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

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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

November 17, 2005
November 21, 2005
May 19, 2006
September 2004
Not Provided
Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
Same as current
Complete list of historical versions of study NCT00256685 on ClinicalTrials.gov Archive Site
Sleep, mood
Same as current
Not Provided
Not Provided
 
Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
  • Menopause
  • Hot Flashes
  • Sleep Disorders
Drug: DVS-233 SR
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
568
Same as current
July 2005
Not Provided

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.

Sexes Eligible for Study: Female
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00256685
3151A2-319
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP