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

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Criteria

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.