Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00369434

Purpose

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.

Condition	Intervention	Phase
Menopause Vasomotor System	Drug: Desvenlafaxine succinate sustained-release (DVS SR)	Phase III

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 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Desvenlafaxine Succinic acid Desvenlafaxine Succinate

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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).

Estimated Enrollment:	450
Study Start Date:	June 2006
Study Completion Date:	February 2007

Detailed 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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369434

Show 34 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3151A2-337
Study First Received:	August 25, 2006
Last Updated:	May 31, 2007
ClinicalTrials.gov Identifier:	NCT00369434 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
O-desmethylvenlafaxine
Therapeutic Uses

Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009