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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Menopause; Vasomotor System

Treatments: Drug: Desvenlafaxine succinate sustained-release (DVS SR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00369434

3151A2-337

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind