NCT00128934

Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 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: 744 (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 (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).

Conditions

• Menstruation Disturbances
• Premenstrual Syndrome

Interventions

Type	Name	Description
DRUG	levonorgestrel/ethinyl estradiol

Timeline

• Start date: 2005-08-01
• Completion: 2007-12-01
• First posted: 2005-08-10
• Last updated: 2007-12-27

Locations

83 sites across 2 countries: United States, Canada