Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women
Phase 2
Completed
- Conditions
- DysmenorrheaDyspareuniaEndometriosisPelvic 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
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