Clinical Trial: Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 75 mg and 150 mg Doses of ERB-041 on the Reduction of Symptoms Associated With Endometriosis During Treatmen
Brief Summary: The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.
Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Current Primary Outcome: severity scores for dysmenorrhea, pelvic pain and deep dyspareunia from baseline through 12 weeks of treatment using the B & B scale administered by the investigator
Original Primary Outcome: To assess the effects and to compare the safety profile of an investigational medication (ERB-041) on the relief of endometriosis symptoms.
Current Secondary Outcome:
- change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment
- change in rescue medication use
- change in health related quality of life questionnaires
Original Secondary Outcome: Clinical and subject assessment of symptoms related to endometriosis and the use of rescue medications to relieve endometriosis symptoms.
Information By: Wyeth is now a wholly owned subsidiary of Pfizer
Dates:
Date Received: April 24, 2006
Date Started: May 2006
Date Completion:
Last Updated: December 7, 2007
Last Verified: December 2007
