Endometriosis (en-doe-me-tree-O-sis) is an often painful disorder in which tissue that normally lines the inside of your uterus — the endometrium — grows outside your uterus. Endometriosis most commonly involves your ovaries, fallopian tubes and the tissue lining your pelvis. Rarely, endometrial tissue may spread beyond pelvic organs. With endometriosis, displaced endometrial tissue continues to act as it normally would — it thickens, breaks down and bleeds with each menstrual cycle. Because this displaced tissue has no way to exit your body, it becomes trapped. Surrounding tissue can become irritated, eventually developing scar tissue and adhesions — abnormal bands of fibrous tissue that can cause pelvic tissues and organs to stick to each other.
You have been asked to participate in 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).
Elagolix (or ABT-620) is a new oral GnRH antagonist that is being developed for the treatment of the symptoms of endometriosis and uterine fibroids. Elagolix inhibits the secretion of the hormones called gonadotropins from brain cells (pituitary gland). As a result, elagolix reduces the production of the sex hormone, estrogen by the ovaries in women. The level of estrogen suppression is dependent on the dose of elagolix. Because elagolix can reduce the normal level, it is being tested for the treatment of the symptoms of endometriosis and uterine fibroids, two conditions that are hormone dependent.
In order for this study to provide good information about how the study drug(s) work(s) in subjects with moderate to severe endometriosis-associated pain, you will be expected to do the following:
● Follow the directions of the investigator and research team including requirements to use an appropriate birth control method.
● Refrain from participation in other research studies while you are a subject in this study.
● Fill out your Diary daily.
● Come to all your scheduled study visits and procedures e.g. endometrial biopsies, DXAs, ultrasounds and collect urine pregnancy tests at home, as required.
● You may be required to stop certain medications and supplements you are currently taking. Certain medications you are taking or have taken in the past may keep you from being in this study. Please review all of your medications with your study doctor.
Some procedures/conditions you may have had in the past may keep you from being in this study. Be sure to tell your study doctor everything you recall about your medical and surgical history.
● Do not change any of your medications or start any new medications (including medications for endometriosis) without checking with your study doctor.
● Use only the protocol specified rescue medications for endometriosis pain. You should contact your study doctor if you feel a change in your rescue medication is needed. Taking these medications on a standing basis for prevention of endometriosis pain is not allowed.
● Take and store your study drug as instructed and return the unused study drug and/or empty containers to the study doctor's office at each visit.
● Do not share your study drug with anyone. You are the only person allowed to take the study drug.
● Keep the study drug and study supplies out of the reach of children and persons of limited ability to read or understand.
● Tell the study staff about any health problems you are having even if you don't think they are important.
● Tell the study staff if you wish to stop being in the study.
● Follow contraception counseling and be willing to consistently use 2 methods of non-hormonal birth control (as applicable) to prevent pregnancy while you are in this study.
● Tell the study staff about the types of birth control methods used and if you had any problems with them.
● For the at home urine pregnancy tests, you will need to report the pregnancy test results to the study staff