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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Disorde

Brief 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.

Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome: Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle

Original Secondary Outcome: Same as current

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: September 13, 2005
Date Started: September 2005
Date Completion:
Last Updated: December 18, 2007
Last Verified: December 2007