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

NCT00369434

Last updated date
Study Location
Montgomery, Alabama, 36106, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Menopause, Vasomotor System
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Hypersensitivity to Venlafaxine


- Myocardial infarction and/or unstable angina within 6 months of screening


- History of seizure disorder


Other exclusions apply.

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Menopause, Vasomotor SystemStudy of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women
NCT00369434
  1. Montgomery, Alabama
  2. Peoria, Arizona
  3. Upland, California
  4. Colorado Springs, Colorado
  5. Brooksville, Florida
  6. Inverness, Florida
  7. Miami, Florida
  8. New Port Richey, Florida
  9. Ocala, Florida
  10. St. Petersburg, Florida
  11. Tampa, Florida
  12. Decatur, Georgia
  13. Savannah, Georgia
  14. Boise, Idaho
  15. Idaho Falls, Idaho
  16. Overland Park, Kansas
  17. Louisville, Kentucky
  18. Portland, Maine
  19. Rockville, Maryland
  20. Billings, Montana
  21. Las Vegas, Nevada
  22. Albuquerque, New Mexico
  23. Winston-Salem, North Carolina
  24. Bismark, North Dakota
  25. Fargo, North Dakota
  26. Cincinnati, Ohio
  27. Eugene, Oregon
  28. Erie, Pennsylvania
  29. Philadelphia, Pennsylvania
  30. Wexford, Pennsylvania
  31. Hilton Head Island, South Carolina
  32. Midvale, Utah
  33. Norfolk, Virginia
  34. Richmond, Virginia
Female
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women
Official Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of DVS SR for Treatment of Vasomotor Symptoms Associated With Menopause
Brief Summary 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.
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.
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
  • Vasomotor System
Intervention  ICMJE Drug: Desvenlafaxine succinate sustained-release (DVS 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
Estimated Enrollment  ICMJE
 (submitted: August 25, 2006)
450
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00369434
Other Study ID Numbers  ICMJE 3151A2-337
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 MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date May 2007

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