Menopause Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 568 |
Est. completion date | July 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12 | |||
Secondary | Sleep, mood |
Status | Clinical Trial | Phase | |
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