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

Phase 2

Completed

• Conditions: Dysmenorrhea; Dyspareunia; Endometriosis; Pelvic Pain

• Registration Number: NCT00318500
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 Description

Not available

Study Timeline

• Study First Submitted: 2006-04-24
• Study First Submitted QC: 2006-04-25
• Study First Posted: 2006-04-26
• Study Start: 2006-05
• Study Completion: 2006-12
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-07
• Last Update Posted: 2007-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
change in health related quality of life questionnaires
change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment
change in rescue medication use