Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
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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
Study Start Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years to 49 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.