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

NCT ID: NCT00369434

Last Updated: 2007-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Menopause Vasomotor System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Desvenlafaxine succinate sustained-release (DVS SR)

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Montgomery, Alabama, United States

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Peoria, Arizona, United States

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Upland, California, United States

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Colorado Springs, Colorado, United States

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Brooksville, Florida, United States

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Inverness, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Decatur, Georgia, United States

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Savannah, Georgia, United States

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Boise, Idaho, United States

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Idaho Falls, Idaho, United States

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Overland Park, Kansas, United States

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Louisville, Kentucky, United States

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Portland, Maine, United States

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Rockville, Maryland, United States

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Billings, Montana, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Eugene, Oregon, United States

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Erie, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Wexford, Pennsylvania, United States

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Hilton Head Island, South Carolina, United States

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Midvale, Utah, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Countries

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United States

Other Identifiers

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3151A2-337

Identifier Type: -

Identifier Source: org_study_id