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NCT00256685 Clinical Trial

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

Menopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00256685
Other study ID # 3151A2-319
Secondary ID
Status Completed
Phase Phase 3
First received November 17, 2005
Last updated May 17, 2006
Start date September 2004
Est. completion date July 2005

Study information
Verified date May 2006
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 568
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• DVS-233 SR

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
Secondary Sleep, mood
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