Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder
1 other identifier
interventional
744
2 countries
83
Brief Summary
The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2005
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 8, 2005
CompletedFirst Posted
Study publicly available on registry
August 10, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedDecember 27, 2007
December 1, 2007
August 8, 2005
December 18, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Secondary Outcomes (1)
Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
Interventions
Eligibility Criteria
You may qualify if:
- Generally healthy, women aged 18 to 49 years.
- 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.
You may not qualify if:
- Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years.
- Contraindication to combination oral contraceptives.
- Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
Unknown Facility
Scottsdale, Arizona, 85251, United States
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Tucson, Arizona, 85715, United States
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Jonesboro, Arkansas, 72401, United States
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Little Rock, Arkansas, 72205, United States
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Carmichael, California, 95608, United States
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Los Angeles, California, 90095, United States
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San Diego, California, 92103, United States
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Denver, Colorado, 80202, United States
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Lakewood, Colorado, 80228, United States
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Longmont, Colorado, 80501, United States
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Middletown, Connecticut, 06457, United States
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New Haven, Connecticut, 06510, United States
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Waterbury, Connecticut, 06708, United States
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Washington D.C., District of Columbia, 20037, United States
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Adventure, Florida, 33180, United States
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Clearwater, Florida, 33761, United States
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Fort Myers, Florida, 33916, United States
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Hialeah, Florida, 33016, United States
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Pembroke Pines, Florida, 33024, United States
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West Palm Beach, Florida, 33407, United States
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Atlanta, Georgia, 30328, United States
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Atlanta, Georgia, 30342, United States
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Savannah, Georgia, 31406, United States
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Boise, Idaho, 83712, United States
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Chicago, Illinois, 60631, United States
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Chicago, Illinois, 60634, United States
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Evansville, Indiana, 47714, United States
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South Bend, Indiana, 46601, United States
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Lexington, Kentucky, 40509, United States
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New Orleans, Louisiana, 70114, United States
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Glen Burnie, Maryland, 21061, United States
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Boston, Massachusetts, 02114, United States
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Pittsfield, Massachusetts, 01201, United States
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Springfield, Massachusetts, 01107, United States
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Brooklyn, New York, 11235, United States
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Buffalo, New York, 14214, United States
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New York, New York, 10021, United States
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Rochester, New York, 14609, United States
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Fayetteville, North Carolina, 28304, United States
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New Bern, North Carolina, 28562, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44122, United States
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Mogadore, Ohio, 44260, United States
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Oklahoma City, Oklahoma, 73112, United States
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Tulsa, Oklahoma, 74135, United States
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Eugene, Oregon, 97401, United States
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Medford, Oregon, 97504, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19114, United States
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Wexford, Pennsylvania, 15090, United States
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East Providence, Rhode Island, 02914, United States
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Greer, South Carolina, 29654, United States
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Hilton Head Island, South Carolina, 29926, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78756, United States
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Carrollton, Texas, 75010, United States
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Conroe, Texas, 77304, United States
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San Antonio, Texas, 78229, United States
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Salt Lake City, Utah, 84107, United States
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Sandy City, Utah, 84070, United States
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Burlington, Vermont, 05401, United States
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Charlottesville, Virginia, 22903, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23230, United States
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Richmond, Virginia, 23233, United States
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Richmond, Virginia, 23294, United States
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Lakewood, Washington, 98499, United States
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Renton, Washington, 98055, United States
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Edmonton, Alberta, T6G 2C8, Canada
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Edmonton, Alberta, T6L 5X8, Canada
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Kelowna, British Columbia, V1Y 2H4, Canada
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Vancouver, British Columbia, V6H 3N1, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Toronto, Ontario, M9W 4L6, Canada
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Hull, Quebec, J9A 1K7, Canada
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Montréal, Quebec, H1T 1P6, Canada
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Montréal, Quebec, H3A 1A1, Canada
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Pointe-Claire, Quebec, H9R 4S3, Canada
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Québec, Quebec, G1R 2W8, Canada
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Québec, Quebec, G1S 2L6, Canada
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Shawinigan, Quebec, G9N 2H6, Canada
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Sherbrooke, Quebec, J1H 4J6, Canada
Related Publications (1)
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.
PMID: 22067793DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 8, 2005
First Posted
August 10, 2005
Study Start
August 1, 2005
Study Completion
December 1, 2007
Last Updated
December 27, 2007
Record last verified: 2007-12