Overview

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.