Clinical Trial: Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS

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

Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Levonorgestrel 90 Mcg and Ethinyl Estradiol 20 Mcg in a Continuous Daily Regimen on Menstrual Cycle-Related Symp

Brief Summary: The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.

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

Current Primary Outcome: To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo

Original Primary Outcome: To evaluate the efficacy of a continuous-use oral contraceptive regimen containing a combination of LNG/EE in preventing moderate to severe menstrual cycle-related symptoms compared with placebo.

Current Secondary Outcome: To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction in subjects with moderate to severe cycle-related symptoms at baseline compared with placebo

Original Secondary Outcome: To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction.

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

Dates:
Date Received: September 7, 2005
Date Started: July 2005
Date Completion:
Last Updated: February 7, 2013
Last Verified: May 2007