Clinical Trial 38848

Miramar, FL 33027


Summary:

A research study of an investigational drug called elagolix (a drug that is not approved by the FDA) because you are an 18 to 49 year old, premenopausal woman with moderate to severe pain associated with endometriosis (for example, painful menstruation, non-menstrual pelvic pain, and painful sexual intercourse).  In addition to elagolix, you may also receive a small amount of estrogen/progestin medication to decrease some of the side effects from elagolix treatment, called add-back therapy.  E2/NETA has been approved by the regulatory authorities in countries, including by the United States (US) FDA, to treat specific medical conditions in postmenopausal women. The E2/NETA is being studied with elagolix in this study to see if it will reduce the occurrence of symptoms associated with low estradiol levels such as hot flashes, and to prevent potential bone loss which may occur in women who take elagolix. Therefore, the use of E2/NETA is investigational (experimental) for the purposes of this study. 


Qualified Participants Must:

• Women must be 18-49 premonopausal
• Be willing not to get pregnant during the study
• Have surgical diagnosis of Endometriosis and Histology of 10 years


Qualified Participants May Receive:

Compensation monthy during study participation 


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.