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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Sleep Disorders; Menopause; Hot Flashes

Treatments: Drug: DVS-233 SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00256685

3151A2-319

Details and patient eligibility

About

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.

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind