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

Wyeth is now a wholly owned subsidiary of Pfizer568 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

568

Conditions

Menopause Hot Flashes Sleep Disorders

Interventions

DVS-233 SRDRUG

Eligibility

Sex: FEMALEMin age: 0 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12

Secondary Outcomes

Sleep, mood

Data from ClinicalTrials.gov

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