Premenstrual Syndrome Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder
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.
Status | Completed |
Enrollment | 526 |
Est. completion date | December 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Romania | S | Bucuresti |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
Argentina, Brazil, Chile, Denmark, Finland, Germany, Mexico, Netherlands, Poland, Romania, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score | |||
Secondary | Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle |
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