Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer
About this trial
Last updated 18 years ago
Study ID
0858A4-318
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18 to 49 Years
Female
Trial Timing
Ended 18 years ago
What is this trial about?
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.
What are the participation requirements?
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.