Status:
COMPLETED
Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Menstruation Disturbances
Premenstrual Syndrome
Eligibility:
FEMALE
18-49 years
Phase:
PHASE3
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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Other exclusions apply.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
744 Patients enrolled
Trial Details
Trial ID
NCT00128934
Start Date
August 1 2005
End Date
December 1 2007
Last Update
December 27 2007
Active Locations (83)
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1
Scottsdale, Arizona, United States, 85251
2
Tucson, Arizona, United States, 85715
3
Jonesboro, Arkansas, United States, 72401
4
Little Rock, Arkansas, United States, 72205