Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women
NCT ID: NCT00683800
Last Updated: 2011-08-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2186 participants
INTERVENTIONAL
2008-06-30
2010-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women
NCT00369434
Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause
NCT00421031
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
NCT00369343
The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms
NCT00401245
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
NCT01121484
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
desvenlafaxine succinate (DVS) SR
desvenlafaxine succinate (DVS) SR
Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days.
2
Placebo
Placebo
Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
desvenlafaxine succinate (DVS) SR
Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days.
Placebo
Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body Mass Index (BMI) less than or equal to 34 kg/m\^2
Exclusion Criteria
* Myocardial infarction an/or unstable angina within 6 months of screening
* History of seizure disorder
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pfizer, Inc
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Mobile, Alabama, United States
Pfizer Investigational Site
Montgomery, Alabama, United States
Pfizer Investigational Site
Glendale, Arizona, United States
Pfizer Investigational Site
Peoria, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Jonesboro, Arkansas, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Vista, California, United States
Pfizer Investigational Site
Walnut Creek, California, United States
Pfizer Investigational Site
Colorado Springs, Colorado, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Englewood, Colorado, United States
Pfizer Investigational Site
Longmont, Colorado, United States
Pfizer Investigational Site
New London, Connecticut, United States
Pfizer Investigational Site
Newark, Delaware, United States
Pfizer Investigational Site
Brooksville, Florida, United States
Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
Daytona Beach, Florida, United States
Pfizer Investigational Site
Fort Myers, Florida, United States
Pfizer Investigational Site
Gainesville, Florida, United States
Pfizer Investigational Site
Lake Worth, Florida, United States
Pfizer Investigational Site
New Port Richey, Florida, United States
Pfizer Investigational Site
Palm Harbor, Florida, United States
Pfizer Investigational Site
Pembroke Pines, Florida, United States
Pfizer Investigational Site
South Miami, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Decatur, Georgia, United States
Pfizer Investigational Site
Decatur, Georgia, United States
Pfizer Investigational Site
Savannah, Georgia, United States
Pfizer Investigational Site
Boise, Idaho, United States
Pfizer Investigational Site
Idaho Falls, Idaho, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
South Bend, Indiana, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
New Orleans, Louisiana, United States
Pfizer Investigational Site
Scarborough, Maine, United States
Pfizer Investigational Site
Ann Arbor, Michigan, United States
Pfizer Investigational Site
Brooklyn Center, Minnesota, United States
Pfizer Investigational Site
Creve Coeur, Missouri, United States
Pfizer Investigational Site
Billings, Montana, United States
Pfizer Investigational Site
Billings, Montana, United States
Pfizer Investigational Site
Lincoln, Nebraska, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Reno, Nevada, United States
Pfizer Investigational Site
Lebanon, New Hampshire, United States
Pfizer Investigational Site
New Brunswick, New Jersey, United States
Pfizer Investigational Site
Albuquerque, New Mexico, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Bismarck, North Dakota, United States
Pfizer Investigational Site
Fargo, North Dakota, United States
Pfizer Investigational Site
Jamestown, North Dakota, United States
Pfizer Investigational Site
Akron, Ohio, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Englewood, Ohio, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
Pfizer Investigational Site
Eugene, Oregon, United States
Pfizer Investigational Site
Medford, Oregon, United States
Pfizer Investigational Site
Erie, Pennsylvania, United States
Pfizer Investigational Site
Erie, Pennsylvania, United States
Pfizer Investigational Site
Jenkintown, Pennsylvania, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site
Wexford, Pennsylvania, United States
Pfizer Investigational Site
Warwick, Rhode Island, United States
Pfizer Investigational Site
Greer, South Carolina, United States
Pfizer Investigational Site
Hilton Head Island, South Carolina, United States
Pfizer Investigational Site
Sioux Falls, South Dakota, United States
Pfizer Investigational Site
Sioux Falls, South Dakota, United States
Pfizer Investigational Site
Watertown, South Dakota, United States
Pfizer Investigational Site
Chattanooga, Tennessee, United States
Pfizer Investigational Site
Knoxville, Tennessee, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Midland, Texas, United States
Pfizer Investigational Site
Plano, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Waco, Texas, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
Sandy City, Utah, United States
Pfizer Investigational Site
Burlington, Vermont, United States
Pfizer Investigational Site
Norfolk, Virginia, United States
Pfizer Investigational Site
Norfolk, Virginia, United States
Pfizer Investigational Site
Richmond, Virginia, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Menomonee Falls, Wisconsin, United States
Pfizer Investigational Site
Calgary, Alberta, Canada
Pfizer Investigational Site
Coquitlam, British Columbia, Canada
Pfizer Investigational Site
Surrey, British Columbia, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Pfizer Investigational Site
Antigonish, Nova Scotia, Canada
Pfizer Investigational Site
Corunna, Ontario, Canada
Pfizer Investigational Site
Ottawa, Ontario, Canada
Pfizer Investigational Site
Sarnia, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Gatineau, Quebec, Canada
Pfizer Investigational Site
L'Ancienne-Lorette, Quebec, Canada
Pfizer Investigational Site
Pointe-Claire, Quebec, Canada
Pfizer Investigational Site
Québec, Quebec, Canada
Pfizer Investigational Site
Saint Romuald, Quebec, Canada
Pfizer Investigational Site
Saint-Janvier, Quebec, Canada
Pfizer Investigational Site
Shawinigan, Quebec, Canada
Pfizer Investigational Site
Sherbrooke, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Archer DF, Pinkerton JV, Guico-Pabia CJ, Hwang E, Cheng RF; Study 3353 Investigators. Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year in women with vasomotor symptoms associated with menopause. Menopause. 2013 Jan;20(1):47-56. doi: 10.1097/gme.0b013e3182775fe9.
Pinkerton JV, Archer DF, Guico-Pabia CJ, Hwang E, Cheng RF. Maintenance of the efficacy of desvenlafaxine in menopausal vasomotor symptoms: a 1-year randomized controlled trial. Menopause. 2013 Jan;20(1):38-46. doi: 10.1097/GME.0b013e318274699f.
Pinkerton JV, Constantine G, Hwang E, Cheng RF; Study 3353 Investigators. Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial. Menopause. 2013 Jan;20(1):28-37. doi: 10.1097/gme.0b013e31826421a8.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B2061011
Identifier Type: -
Identifier Source: secondary_id
3151A2-3353
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.