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Trial record 1 of 1 for:    NCT00256685
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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

Tracking Information
First Submitted Date  ICMJE November 17, 2005
First Posted Date  ICMJE November 21, 2005
Last Update Posted Date May 19, 2006
Study Start Date  ICMJE September 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00256685 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
Sleep, mood
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause
Official Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Menopause
  • Hot Flashes
  • Sleep Disorders
Intervention  ICMJE Drug: DVS-233 SR
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 17, 2005)
568
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00256685
Other Study ID Numbers  ICMJE 3151A2-319
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date May 2006

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