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Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vasomotor Symptoms

Intervention: desvenlafaxine succinate (DVS) SR (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) in menopausal women.

Clinical Details

Official title: A Double-Blind, Randomized, Placebo-Controlled Study Assessing The Safety And Efficacy Of DVS SR For The Treatment Of Vasomotor Symptoms Associated With Menopause

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4

Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12

Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4

Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12

Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events

Secondary outcome:

Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes

Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes

Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes

Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes

Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12

Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12

Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12

Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6

Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12

Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12

Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6

Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12

Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12

Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6

Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12

Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12

Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6

Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12

Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12

Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6

Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12

Eligibility

Minimum age: 45 Years. 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 34 kg/m^2

Exclusion Criteria:

- Hypersensitivity to Venlafaxine

- Myocardial infarction an/or unstable angina within 6 months of screening

- History of seizure disorder

Locations and Contacts

Pfizer Investigational Site, Quebec G1S 2L6, Canada

Pfizer Investigational Site, Birmingham, Alabama 35235, United States

Pfizer Investigational Site, Mobile, Alabama 36608, United States

Pfizer Investigational Site, Montgomery, Alabama 36106, United States

Pfizer Investigational Site, Calgary, Alberta T2N 4L7, Canada

Pfizer Investigational Site, Glendale, Arizona 85308, United States

Pfizer Investigational Site, Peoria, Arizona 85381, United States

Pfizer Investigational Site, Tucson, Arizona 85710, United States

Pfizer Investigational Site, Tucson, Arizona 85712, United States

Pfizer Investigational Site, Tucson, Arizona 85715, United States

Pfizer Investigational Site, Jonesboro, Arkansas 72401, United States

Pfizer Investigational Site, Little Rock, Arkansas 72205, United States

Pfizer Investigational Site, Little Rock, Arkansas 72223, United States

Pfizer Investigational Site, Coquitlam, British Columbia V3K 3V9, Canada

Pfizer Investigational Site, Surrey, British Columbia V4A 2H9, Canada

Pfizer Investigational Site, San Diego, California 92103, United States

Pfizer Investigational Site, San Diego, California 92108, United States

Pfizer Investigational Site, San Diego, California 92123, United States

Pfizer Investigational Site, Vista, California 92083, United States

Pfizer Investigational Site, Walnut Creek, California 94598, United States

Pfizer Investigational Site, Colorado Springs, Colorado 80910, United States

Pfizer Investigational Site, Denver, Colorado 80218, United States

Pfizer Investigational Site, Englewood, Colorado 80112, United States

Pfizer Investigational Site, Longmont, Colorado 80501, United States

Pfizer Investigational Site, New London, Connecticut 06320, United States

Pfizer Investigational Site, Newark, Delaware 19713, United States

Pfizer Investigational Site, Brooksville, Florida 34601, United States

Pfizer Investigational Site, Clearwater, Florida 33759, United States

Pfizer Investigational Site, Clearwater, Florida 33761, United States

Pfizer Investigational Site, Daytona Beach, Florida 32114, United States

Pfizer Investigational Site, Fort Myers, Florida 33916, United States

Pfizer Investigational Site, Gainesville, Florida 32610, United States

Pfizer Investigational Site, Lake Worth, Florida 33461, United States

Pfizer Investigational Site, New Port Richey, Florida 34652, United States

Pfizer Investigational Site, Palm Harbor, Florida 34684, United States

Pfizer Investigational Site, Pembroke Pines, Florida 33024, United States

Pfizer Investigational Site, South Miami, Florida 33143, United States

Pfizer Investigational Site, Tampa, Florida 33606, United States

Pfizer Investigational Site, West Palm Beach, Florida 33409, United States

Pfizer Investigational Site, Atlanta, Georgia 30342, United States

Pfizer Investigational Site, Decatur, Georgia 30033, United States

Pfizer Investigational Site, Decatur, Georgia 30319, United States

Pfizer Investigational Site, Savannah, Georgia 31406, United States

Pfizer Investigational Site, Boise, Idaho 83702, United States

Pfizer Investigational Site, Idaho Falls, Idaho 83404, United States

Pfizer Investigational Site, Indianapolis, Indiana 46202, United States

Pfizer Investigational Site, Indianapolis, Indiana 46260, United States

Pfizer Investigational Site, South Bend, Indiana 46601, United States

Pfizer Investigational Site, Overland Park, Kansas 66210, United States

Pfizer Investigational Site, Lexington, Kentucky 40509, United States

Pfizer Investigational Site, Louisville, Kentucky 40291, United States

Pfizer Investigational Site, New Orleans, Louisiana 70114, United States

Pfizer Investigational Site, Scarborough, Maine 04074, United States

Pfizer Investigational Site, Winnipeg, Manitoba R3T 2E8, Canada

Pfizer Investigational Site, Ann Arbor, Michigan 48106, United States

Pfizer Investigational Site, Brooklyn Center, Minnesota 55430, United States

Pfizer Investigational Site, Creve Coeur, Missouri 63141, United States

Pfizer Investigational Site, Billings, Montana 59102, United States

Pfizer Investigational Site, Billings, Montana 59101, United States

Pfizer Investigational Site, Lincoln, Nebraska 68510, United States

Pfizer Investigational Site, Las Vegas, Nevada 89109, United States

Pfizer Investigational Site, Las Vegas, Nevada 89146, United States

Pfizer Investigational Site, Reno, Nevada 89502, United States

Pfizer Investigational Site, Lebanon, New Hampshire 03756, United States

Pfizer Investigational Site, New Brunswick, New Jersey 08901, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87102, United States

Pfizer Investigational Site, New York, New York 10032, United States

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States

Pfizer Investigational Site, Bismarck, North Dakota 58501, United States

Pfizer Investigational Site, Fargo, North Dakota 58104, United States

Pfizer Investigational Site, Jamestown, North Dakota 58401, United States

Pfizer Investigational Site, Antigonish, Nova Scotia B2G 2C2, Canada

Pfizer Investigational Site, Akron, Ohio 44311, United States

Pfizer Investigational Site, Cincinnati, Ohio 45267-0457, United States

Pfizer Investigational Site, Cleveland, Ohio 44122, United States

Pfizer Investigational Site, Englewood, Ohio 45322, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73112-4481, United States

Pfizer Investigational Site, Corunna, Ontario N0N 1G0, Canada

Pfizer Investigational Site, Ottawa, Ontario K1H 7W9, Canada

Pfizer Investigational Site, Sarnia, Ontario N7T 4X3, Canada

Pfizer Investigational Site, Toronto, Ontario M5B 1W8, Canada

Pfizer Investigational Site, Toronto, Ontario M4S 1Y2, Canada

Pfizer Investigational Site, Toronto, Ontario M9W 4L6, Canada

Pfizer Investigational Site, Eugene, Oregon 97401, United States

Pfizer Investigational Site, Medford, Oregon 97504, United States

Pfizer Investigational Site, Erie, Pennsylvania 16502, United States

Pfizer Investigational Site, Erie, Pennsylvania 16507-1411, United States

Pfizer Investigational Site, Jenkintown, Pennsylvania 19046, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19114, United States

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15206, United States

Pfizer Investigational Site, Wexford, Pennsylvania 15090, United States

Pfizer Investigational Site, Gatineau, Quebec J9A 1K7, Canada

Pfizer Investigational Site, L'Ancienne-Lorette, Quebec G2E 2X1, Canada

Pfizer Investigational Site, Pointe Claire, Quebec H9R 4S3, Canada

Pfizer Investigational Site, Saint-Janvier, Quebec J7J 2K8, Canada

Pfizer Investigational Site, Shawinigan, Quebec G9N 2H6, Canada

Pfizer Investigational Site, Sherbrooke, Quebec J1H 4J6, Canada

Pfizer Investigational Site, St-Romuald, Quebec G6W 5M6, Canada

Pfizer Investigational Site, Warwick, Rhode Island 02886, United States

Pfizer Investigational Site, Greer, South Carolina 29651, United States

Pfizer Investigational Site, Hilton Head Island, South Carolina 29926, United States

Pfizer Investigational Site, Sioux Falls, South Dakota 57104, United States

Pfizer Investigational Site, Sioux Falls, South Dakota 57105, United States

Pfizer Investigational Site, Watertown, South Dakota 57201, United States

Pfizer Investigational Site, Chattanooga, Tennessee 37404, United States

Pfizer Investigational Site, Knoxville, Tennessee 37920, United States

Pfizer Investigational Site, Nashville, Tennessee 37203, United States

Pfizer Investigational Site, Dallas, Texas 75234, United States

Pfizer Investigational Site, Houston, Texas 77030, United States

Pfizer Investigational Site, Midland, Texas 79705, United States

Pfizer Investigational Site, Plano, Texas 75093, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Waco, Texas 76712, United States

Pfizer Investigational Site, Salt Lake City, Utah 84117, United States

Pfizer Investigational Site, Sandy, Utah 84070, United States

Pfizer Investigational Site, Burlington, Vermont 05401, United States

Pfizer Investigational Site, Norfolk, Virginia 23502, United States

Pfizer Investigational Site, Norfolk, Virginia 23507, United States

Pfizer Investigational Site, Richmond, Virginia 23294, United States

Pfizer Investigational Site, Seattle, Washington 98105, United States

Pfizer Investigational Site, Menomonee Falls, Wisconsin 53051, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: June 2008
Last updated: July 21, 2011

Page last updated: August 23, 2015

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