Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Levonorgestrel; Polyestradiol phosphate

Criteria

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.