Clinical Trial Seeking Participants
Endometriosis Treatment Clinical Trial
IRB 8498 (PI: Jeffrey Jensen, MD, MPH)
The Women’s Health Research Unit is conducting a study to investigate a new type of treatment for moderate to severe endometriosis associated pain.
Open for Enrollment
Why is this study being done?
The study drug is a new drug that is being developed for the treatment of endometriosis (a condition in which the tissue that behaves like the cells lining the uterus grows in other areas of the body) and uterine fibroids (noncancerous tumors that develop in the uterus). The study drug is very similar to a natural hormone that is made by brain cells. The study drug partially reduces the production of the female hormone estrogen in the ovaries.
The purpose of this study is to determine:
The primary objective of this study is to evaluate the safety, tolerability, and efficacy of elagolix, administered once daily or twice daily for 3 months in the management of moderate to severe endometriosis-associated pain, and to evaluate the effect of elagolix treatment on analgesic use for endometriosis-associated pain. Secondary efficacy objectives include assessment of persistence of efficacy at 6 months, and assessments of other endometriosis-related symptoms, analgesic use, as well as quality of life endpoints.
Who is eligible to participate?
Pre-menopausal women between the ages of 18 and 49 who:
- Are in good general health
- Have regular menstrual periods (23-33 days)
- Diagnosis of endometriosis
You must not be willing to use two forms of non-hormonal contraception and stop taking your hormonal form of birth control. You do not have to be sexually active to participate in this research study.
What is the compensation for this study?
Qualified participants will receive, at no cost:
- Well woman exams
- Compensation for time and travel of up to $2290 for the 18 month period of the study