A Phase 3 interventional study of Elagolix and Placebo in Endometriosis, sponsored by AbbVie. Active, not recruiting at 179 sites in 2 countries. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's planned enrollment of 800 is above the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive double-blind placebo on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.
Drug: Elagolix · Drug: Placebo · Drug: Combined Oral Contraceptive
Participants will receive double-blind Elagolix on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.
Drug: Elagolix · Drug: Combined Oral Contraceptive
Participants will receive double-blind elagolix in combination with COC (combined oral contraceptive) on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC for 15 months. Participants will be followed-up for up to 12 months.
Drug: Elagolix · Drug: Combined Oral Contraceptive
Tablet:Oral
Also known as: ABT-620, Orilissa
Tablet:Oral
Tablet:Oral
Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale
DYS response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use.
Time frame: Month 3
Number of Participants Experiencing Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Time frame: Up to approximately 50 months
Percentage of Responders Based on Non-Menstrual Pelvic Pain (NMPP) Pain Scale
NMPP response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use.
Time frame: Month 3
Showing the first 100 of 179 sites across 2 countries.
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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