A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe Pain
A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe Pain
Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain.
Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico.
Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18.
There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35294-7333, United States
Washington D.C., District of Columbia 20010, United States
Fort Myers, Florida 33912, United States
Palm Harbor, Florida 34684, United States
College Park, Georgia 30349-3103, United States
Smyrna, Georgia 30082-5166, United States
Snellville, Georgia 30078-6191, United States
Park Ridge, Illinois 60068, United States
Wichita, Kansas 67205-1138, United States
St Louis, Missouri 63141, United States
Neptune City, New Jersey 07753-4859, United States
New York, New York 10065, United States
Durham, North Carolina 27713, United States
Winston-Salem, North Carolina 27103-4109, United States
Cincinnati, Ohio 45267-0585, United States
Hershey, Pennsylvania 17033-2360, United States
Summerville, South Carolina 29485-7539, United States
Dallas, Texas 75390-8575, United States
Houston, Texas 77054-2934, United States
Newport News, Virginia 23606, United States
Richmond, Virginia 23226-3786, United States