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

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

Official Title: 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

Brief 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).

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: Mean change in average Daily record of Severity of Problems 21-item total daily score

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

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

Dates:
Date Received: August 8, 2005
Date Started: August 2005
Date Completion:
Last Updated: December 18, 2007
Last Verified: December 2007