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Elagolix

Phase 3

Endometriosis | Small molecule | Other |AbbVie Inc.|Last Updated: Nov 19, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials6
Total Enrollment3,741
FDA Designations
No designations recorded
Clinical Trials (6)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04333576Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe PainPHASE3 ACTIVE NOT_RECRUITING 800Aug 10, 2020Jun 1, 2030Nov 19, 2025179 United States, Puerto Rico
NCT02143713Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated PainPHASE3 COMPLETED 496May 27, 2014May 23, 2017Jul 13, 2021 -
NCT01931670A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated PainPHASE3 COMPLETED 815Sep 9, 2013Dec 19, 2016Sep 7, 2018 -
NCT01760954Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated PainPHASE3 COMPLETED 506Dec 28, 2012Apr 15, 2016Jul 13, 2021 -
NCT01620528A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated PainPHASE3 COMPLETED 872May 22, 2012Sep 28, 2015Sep 18, 2018 -
NCT00437658Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of EndometriosisPHASE2 COMPLETED 252Dec 11, 2006Nov 24, 2008Oct 12, 2018 -
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Study Endpoints
Primary Endpoints
Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale
Month 3

DYS response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use.

Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6

Response was defined as a reduction of -0.85 or more from baseline in dysmenorrhea (pain during menstruation) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average rescue analgesic pill count and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-671. Participants recorded rescue analgesic use for endometriosis-associated pain daily and dysmenorrhea and its impact on daily activities each day of their period in an electronic diary (e-Diary). Dysmenorrhea was assessed according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Analgesic use and pain scores were averaged over the 35 days prior to each visit.

Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6

Response was defined as a reduction of -0.43 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-671. Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.

Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
At Month 3 of the Treatment Period

The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.

Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
At Month 3 of Treatment Period

The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.

Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24
Baseline and week 24

Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.

Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24
Baseline and week 24

Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.

Secondary Endpoints
Percentage of Responders Based on Non-Menstrual Pelvic Pain (NMPP) Pain Scale
Month 3
Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5
Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Double-Blind: PlaceboPLACEBO_COMPARATORParticipants 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.
Double-Blind: ElagolixEXPERIMENTALParticipants 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.
Double-Blind: Elagolix + COCEXPERIMENTALParticipants 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.
Elagolix 150 mg QDEXPERIMENTALParticipants received elagolix 150 mg tablets once a day (QD) for 6 months.
Elagolix 200 mg BIDEXPERIMENTALParticipants received elagolix 200 mg tablets twice a day (BID) for 6 months.
PlaceboPLACEBO_COMPARATORPlacebo twice daily (BID) for the 6-month Treatment Period
Elagolix 75 mg BIDEXPERIMENTALParticipants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.
DMPA-SCACTIVE_COMPARATORParticipants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12.
Interventions
NameTypeDescription
ElagolixDRUGTablet:Oral
PlaceboDRUGTablet:Oral
Combined Oral ContraceptiveDRUGTablet:Oral
Subcutaneous depot medroxyprogesterone acetate (DMPA-SC)DRUGProvided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe.
Placebo to ElagolixDRUGMatching placebo tablets for oral administration
Placebo to DMPA-SCDRUGMatching placebo for subcutaneous injection in a pre-filled syringe
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Eligibility Criteria
Age Range18 Years — 49 Years
SexFEMALE
Healthy VolunteersNo
Study Sites179

Inclusion Criteria: * Documented surgical confirmation of endometriosis and associated moderate to severe pain. * Participants must agree to use dual non-hormonal methods of contraception consistently during washout (if applicable), screening, and 3-month double-blind placebo-controlled treatment p...

Countries:United StatesPuerto Rico
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04333576primaryCompletionDate: changed
LOWMay 24, 2026NCT04333576studyFirstPostDate: changed