Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women
A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of DVS SR for Treatment of Vasomotor Symptoms Associated With Menopause
1 other identifier
interventional
450
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2006
Shorter than P25 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 25, 2006
CompletedFirst Posted
Study publicly available on registry
August 29, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedJune 1, 2007
May 1, 2007
August 25, 2006
May 31, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.
Secondary Outcomes (2)
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).
Interventions
Eligibility Criteria
You may qualify if:
- Generally healthy, postmenopausal women who seek treatment for hot flushes
- Body Mass Index (BMI) less than or equal to 40 kg/m2
You may not qualify if:
- Hypersensitivity to Venlafaxine
- Myocardial infarction and/or unstable angina within 6 months of screening
- History of seizure disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Unknown Facility
Montgomery, Alabama, 36106, United States
Unknown Facility
Peoria, Arizona, 85381, United States
Unknown Facility
Upland, California, 91786, United States
Unknown Facility
Colorado Springs, Colorado, 80910, United States
Unknown Facility
Brooksville, Florida, 34613, United States
Unknown Facility
Inverness, Florida, 34452, United States
Unknown Facility
Miami, Florida, 33143, United States
Unknown Facility
New Port Richey, Florida, 34652, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
St. Petersburg, Florida, 33709, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Savannah, Georgia, 31406, United States
Unknown Facility
Boise, Idaho, 83702, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Overland Park, Kansas, 66210, United States
Unknown Facility
Louisville, Kentucky, 40291, United States
Unknown Facility
Portland, Maine, 04102, United States
Unknown Facility
Rockville, Maryland, 20852, United States
Unknown Facility
Billings, Montana, 59102, United States
Unknown Facility
Las Vegas, Nevada, 89146, United States
Unknown Facility
Albuquerque, New Mexico, 87102, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Bismarck, North Dakota, 58501, United States
Unknown Facility
Fargo, North Dakota, 58104, United States
Unknown Facility
Cincinnati, Ohio, 45267-0457, United States
Unknown Facility
Eugene, Oregon, 97401, United States
Unknown Facility
Erie, Pennsylvania, 16502, United States
Unknown Facility
Philadelphia, Pennsylvania, 19114, United States
Unknown Facility
Wexford, Pennsylvania, 15090, United States
Unknown Facility
Hilton Head Island, South Carolina, 29926, United States
Unknown Facility
Midvale, Utah, 84047, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Richmond, Virginia, 23294, United States
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2006
First Posted
August 29, 2006
Study Start
June 1, 2006
Study Completion
February 1, 2007
Last Updated
June 1, 2007
Record last verified: 2007-05