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

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menopause; Vasomotor System

Intervention: Desvenlafaxine succinate sustained-release (DVS SR) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Summary

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.

Clinical Details

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

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

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

Secondary outcome:

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).

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Montgomery, Alabama 36106, United States

Peoria, Arizona 85381, United States

Upland, California 91786, United States

Colorado Springs, Colorado 80910, United States

Brooksville, Florida 34613, United States

Inverness, Florida 34452, United States

Miami, Florida 33143, United States

New Port Richey, Florida 34652, United States

Ocala, Florida 34471, United States

St. Petersburg, Florida 33709, United States

Tampa, Florida 33606, United States

Decatur, Georgia 30033, United States

Savannah, Georgia 31406, United States

Boise, Idaho 83702, United States

Idaho Falls, Idaho 83404, United States

Overland Park, Kansas 66210, United States

Louisville, Kentucky 40291, United States

Portland, Maine 04102, United States

Rockville, Maryland 20852, United States

Billings, Montana 59102, United States

Las Vegas, Nevada 89146, United States

Albuquerque, New Mexico 87102, United States

Winston-Salem, North Carolina 27103, United States

Bismark, North Dakota 58501, United States

Fargo, North Dakota 58104, United States

Cincinnati, Ohio 45267-0457, United States

Eugene, Oregon 97401, United States

Erie, Pennsylvania 16502, United States

Philadelphia, Pennsylvania 19114, United States

Wexford, Pennsylvania 15090, United States

Hilton Head Island, South Carolina 29926, United States

Midvale, Utah 84047, United States

Norfolk, Virginia 23507, United States

Richmond, Virginia 23294, United States

Additional Information

Starting date: June 2006
Last updated: May 31, 2007

Page last updated: August 23, 2015

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