Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
NCT ID: NCT00128934
Last Updated: 2007-12-27
Study Results
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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COMPLETED
PHASE3
744 participants
INTERVENTIONAL
2005-08-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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levonorgestrel/ethinyl estradiol
Eligibility Criteria
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Inclusion Criteria
* History of severe PMS symptoms over the last year, as determined by the investigator.
* Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit.
Exclusion Criteria
* Contraindication to combination oral contraceptives.
* Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
Other exclusions apply.
18 Years
49 Years
FEMALE
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Principal Investigators
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Medical Monitor, MD
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Scottsdale, Arizona, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Carmichael, California, United States
Los Angeles, California, United States
San Diego, California, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Longmont, Colorado, United States
Middletown, Connecticut, United States
New Haven, Connecticut, United States
Waterbury, Connecticut, United States
Washington D.C., District of Columbia, United States
Adventure, Florida, United States
Clearwater, Florida, United States
Fort Myers, Florida, United States
Hialeah, Florida, United States
Pembroke Pines, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
South Bend, Indiana, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Glen Burnie, Maryland, United States
Boston, Massachusetts, United States
Pittsfield, Massachusetts, United States
Springfield, Massachusetts, United States
Brooklyn, New York, United States
Buffalo, New York, United States
New York, New York, United States
Rochester, New York, United States
Fayetteville, North Carolina, United States
New Bern, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Mogadore, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Medford, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wexford, Pennsylvania, United States
East Providence, Rhode Island, United States
Greer, South Carolina, United States
Hilton Head Island, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Carrollton, Texas, United States
Conroe, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Sandy City, Utah, United States
Burlington, Vermont, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Lakewood, Washington, United States
Renton, Washington, United States
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Hull, Quebec, Canada
Montréal, Quebec, Canada
Montréal, Quebec, Canada
Pointe-Claire, Quebec, Canada
Québec, Quebec, Canada
Québec, Quebec, Canada
Shawinigan, Quebec, Canada
Sherbrooke, Quebec, Canada
Countries
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References
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Halbreich U, Freeman EW, Rapkin AJ, Cohen LS, Grubb GS, Bergeron R, Smith L, Mirkin S, Constantine GD. Continuous oral levonorgestrel/ethinyl estradiol for treating premenstrual dysphoric disorder. Contraception. 2012 Jan;85(1):19-27. doi: 10.1016/j.contraception.2011.05.008. Epub 2011 Jul 13.
Other Identifiers
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0858A4-316
Identifier Type: -
Identifier Source: org_study_id
NCT00278720
Identifier Type: -
Identifier Source: nct_alias