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

Tracking Information

First Received Date ^ICMJE

November 17, 2005

Last Updated Date

May 17, 2006

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00256685 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sleep, mood

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Menopause
Hot Flashes
Sleep Disorders

Intervention ^ICMJE

Drug: DVS-233 SR

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

568

Completion Date

July 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00256685

Responsible Party

Study ID Numbers ^ICMJE

3151A2-319

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

May 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP