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 Women
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 46
- Primary Endpoint
- To assess the effects and to compare the safety profile of an investigational
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Surgical diagnosis of endometriosis within 5 years
- •Not pregnant and not lactating
- •Willing to use non-hormonal contraception, history of regular menstrual cycles
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
To assess the effects and to compare the safety profile of an investigational
medication on the relief of endometriosis-related symptoms.
Secondary Outcomes
- Clinical and subject assessment of symptoms related to endometriosis and the
- use of analgesia to relieve symptoms.