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

Purpose

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.

Condition	Intervention	Phase
Menopause Hot Flashes Sleep Disorders	Drug: DVS-233 SR	Phase III

MedlinePlus related topics:

Menopause Sleep Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Sleep, mood

Estimated Enrollment:	568
Study Start Date:	September 2004
Estimated Study Completion Date:	July 2005

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256685

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Study ID Numbers:	3151A2-319
First Received:	November 17, 2005
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00256685
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Menopause

Study placed in the following topic categories:

Signs and Symptoms

Mental Disorders

Hot Flashes

Neurologic Manifestations

Sleep Disorders

Menopause

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00256685