Research Study for Women with Endometriosis

The Women's Health Clinical Research Center is currently recruiting premenopausal woman with endometriosis pain to participate in a research study.

The purpose of this study is to look at the safety and effectiveness of elagolix 150 mg when taken together with a combined oral contraceptive (COC) that contains an estrogen and a progesterone, in premenopausal women with endometriosis pain.

We are currently recruiting premenopausal women with endometriosis and associated moderate to severe pain who are 18 to 49 years old to participate in this research study. Elagolix 150 mg once daily has been approved by the United States Food and Drug Administration (US FDA) and Health Canada to treat the symptoms of endometriosis. In addition to elagolix, you may also receive a COC or birth control pill which contains estrogen/progestin medication. This COC has also been approved by the US FDA to prevent pregnancy in women who elect to use oral contraceptives as a method of contraception. However, elagolix is not approved to be used together with a COC, therefore the use of elagolix with the COC is investigational (experimental) for the purposes of this study.

 

Your participation in this study will last approximately up to 45 months and include approximately 14 study visits to the research center and approximately 10 phone visits (including all study periods).

 

To be eligible to participate, you need a previous surgical diagnosis of endometriosis

Participation in this study involves:

  • frequent site visits

  • study related medical exams

  • transvaginal ultrasound, ECG and DXA scan

  • blood tests

  • investigational medication or placebo

 

Qualified participants:

  • are women ages 18-49

  • are in good general health

  • have a surgical diagnosis of endometriosis

  • are not using or are willing to stop using other treatments (including hormonal contraceptives or hormonal medications)

  • will receive medical exams

  • may receive compensation for time and travel

 

To complete the pre-screening survey for this study, visit:

(https://redcap.med.upenn.edu/surveys/?s=PM7JCW99CJMMRN48) or call 215.662.7727