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

Wyeth is now a wholly owned subsidiary of Pfizer450 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

450

Conditions

Menopause Vasomotor System

Interventions

Desvenlafaxine succinate sustained-release (DVS SR)DRUG

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (34)

Unnamed facility

Outcomes

Primary Outcomes

The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.

Secondary Outcomes

The number of awakenings due to VMS and the total mood disturbance score (Profile of Mood States [POMS]).

The scores on the Greene Climacteric Scale (GCS), the Visual Analog Scale-Pain Intensity (VAS-PI), and the Satisfaction Survey (SS).

Data from ClinicalTrials.gov

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