Status:
COMPLETED
Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Premenstrual Syndrome
Menstruation Disturbances
Eligibility:
FEMALE
18-49 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.
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 exclusion applies.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT00195559
Start Date
September 1 2005
End Date
December 1 2007
Last Update
December 27 2007
Active Locations (51)
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1
Buenos Aires, Argentina
2
Córdoba, Argentina
3
Rosario-Santa Fe, Argentina
4
Curitiba, Brazil