NCT00195559

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 526 (estimated)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Premenstrual Syndrome
• Menstruation Disturbances

Interventions

Type	Name	Description
DRUG	Levonorgestrel/Ethinyl Estradiol

Timeline

• Start date: 2005-09-01
• Completion: 2007-12-01
• First posted: 2005-09-19
• Last updated: 2007-12-27

Locations

51 sites across 12 countries: Argentina, Brazil, Chile, Denmark, Finland, Germany, Mexico, Netherlands, Poland, Romania, Sweden, United Kingdom