Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Levonorgestrel 90 Mcg and Ethinyl Estradiol 20 Mcg in a Continuous Daily Regimen on Menstrual Cycle-Related Symptoms
Study Start Date :
Actual Primary Completion 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:
Healthy women aged 18 to 49 years
Regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1
History of menstrual cycle related symptoms as determined by the investigator.
Contraindication to combination oral contraceptives
Depression requiring hospitalization or associated with suicidal ideation within the last 3 years
Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.