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Clinical Trial Name -Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women

 
Original Study ID : 3142A2-203
NCT ID : NCT00318500
Brief Title : Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women
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 Treatment and Post Treatment in Reproductive-Aged Women
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.
Source : Wyeth
Overall Status : Completed
Start Date : May 2006
End Date : December 2006
Completion Date : December 2006
Official Title : Phase 2
Phase : Interventional
Study Design : Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Enrollment : 150
Verification Date : December 2007
First Received Date : April 24, 2006
Trial Eligibility
Criteria :
Inclusion Criteria:

- Surgical diagnosis of endometriosis within the last 10 years

- Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual
cycles who are willing to use non-hormonal contraception

Exclusion Criteria:

- Conditions requiring the use of chronic pain therapy

- Prophylactic use of analgesics to avoid endometriosis-related pain
Gender : Female
Minimum Age : 18 Years
Maximum Age : 45 Years
Healthy Volunteers : No
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