Clinical Trial: Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women

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

Official Title: A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Effect of ERB-041 in the Reduction of Symptoms Associated With Endometriosis in Reproductive-Age

Brief Summary: The purpose of this investigational study is to determine if a study medication is safe and effective in reducing the symptoms associated with endometriosis; if the study medication reduces the need for pain medication for endometriosis symptoms; and if the study medication improves a participant's ability to carry out daily activities. Qualified participants will receive no cost treatment, which may include study-related examinations, diagnostic procedures including a Pap smear, laboratory testing, and a mammogram (aged 40-45). Qualified participants will also receive study medication at no cost. As a participant, the study volunteer may also experience the satisfaction of knowing she is helping the advancement of women's health care.

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

Current Primary Outcome:

  • To assess the effects and to compare the safety profile of an investigational
  • medication on the relief of endometriosis-related symptoms.


Original Primary Outcome:

Current Secondary Outcome:

  • Clinical and subject assessment of symptoms related to endometriosis and the
  • use of analgesia to relieve symptoms.


Original Secondary Outcome:

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

Dates:
Date Received: May 9, 2005
Date Started: January 2005
Date Completion:
Last Updated: April 30, 2015
Last Verified: December 2007