Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
- Conditions
- Endometriosis
- Registration Number
- NCT00110487
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
- Surgical diagnosis of endometriosis within 5 years
- Not pregnant and not lactating
- Willing to use non-hormonal contraception, history of regular menstrual cycles
- Hysterectomy, surgical treatment for endometriosis within 3 months
- Certain medications for the treatment of endometriosis
- Previous history of a malignancy
- Abnormalities on physical or gyn exams and abnormal lab tests
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess the effects and to compare the safety profile of an investigational medication on the relief of endometriosis-related symptoms.
- Secondary Outcome Measures
Name Time Method Clinical and subject assessment of symptoms related to endometriosis and the use of analgesia to relieve symptoms.