Elagolix Clinical Trials (2026): 33 Studies for Endometriosis & Uterine Fibroids
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
33 Elagolix clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 12 indications (including Endometriosis & Uterine Fibroids) and 9,322 total planned enrollment. 15 Phase 3 Elagolix trials and 9 Phase 2, 5 Phase 4 are listed. 3 Elagolix clinical trials are actively recruiting at 2 U.S. sites across 2 states. Most recent activity: NCT04333576 (Jun 2030).
Where to Participate: All Elagolix Trial Sites in the U.S. (2 sites across 2 states)
Every actively recruiting Elagolixtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| CT | Yale School of Medicine | New Haven06519 | NCT03746535 | Map |
| PA | Noll Laboratory | University Park16802 | NCT06798571 | Map |
Elagolix clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | enrolling by invitation | completed | terminated | unknown | Total |
|---|---|---|---|---|---|---|---|
| Early P1 | 1 | 1 | 2 | ||||
| P1 | 1 | 1 | |||||
| P2 | 8 | 1 | 9 | ||||
| P3 | 2 | 11 | 1 | 1 | 15 | ||
| P4 | 1 | 1 | 1 | 1 | 1 | 5 | |
| N/A | 1 | 1 |
Recruiting Elagolix clinical trials (3)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT03746535 | Cardiovascular Disease Risk in Women With Endometriosis | Early P1 | Endometriosis | 40 | Jul 2022 |
| NCT07532876 | Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain | P4 | Endometriosis (Diagnosis) | 90 | May 2026 |
| NCT06798571 | Role of Menopause in Thermoregulation | P4 | Menopause | 24 | Mar 2025 |
Elagolix clinical trials by indication
Endometriosis (14)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04333576 | ELARIS EM-COC | P3 | active not recruiting | Study 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 Pain |
| NCT03746535 | — | Early P1 | recruiting | Cardiovascular Disease Risk in Women With Endometriosis |
| NCT06076486 | — | P3 | completed | A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated Pain |
| NCT05648669 | — | P3 | unknown | A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain |
| NCT03213457 | — | P3 | completed | A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain |
| NCT04039204 | EFFECT | P2 | completed | Elagolix for Fertility Enhancement Clinical Trial |
| NCT04614246 | SCHUMANN | P2 | terminated | Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb |
| NCT03343067 | — | P3 | terminated | A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain |
| + 6 more, see All trials below. | ||||
Uterine Fibroids (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03886220 | — | P4 | completed | A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women |
| NCT02925494 | — | P3 | completed | An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
| NCT02691494 | — | P3 | completed | Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study) |
| NCT02654054 | — | P3 | completed | Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women |
Infertility (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06375811 | PREGnant | P3 | active not recruiting | Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp |
| NCT04173169 | PREGnant | P3 | completed | Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis |
| NCT04445025 | — | Early P1 | completed | Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis |
Heavy Menstrual Bleeding (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04856306 | Magical | N/A | unknown | Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L |
| NCT03271489 | — | P3 | completed | Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women |
Heavy Uterine Bleeding (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01817530 | HMB | P2 | completed | Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF) |
| NCT01441635 | — | P2 | completed | Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids |
Endometriosis, Pain (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00973973 | — | P2 | completed | Efficacy and Safety Study of Elagolix in Women With Endometriosis |
| NCT00619866 | NBI-56418 | P2 | completed | An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis |
Endometriosis (Diagnosis) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07532876 | — | P4 | enrolling by invitation | Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain |
Menopause (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06798571 | — | P4 | recruiting | Role of Menopause in Thermoregulation |
Mild Autonomous Cortisol Excess (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05038878 | MACE | P4 | terminated | An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women |
Ovulation; Failure or Lack of (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04060992 | — | P4 | unknown | Hormonal Effects of the Oral Gonadotropin Releasing Hormone (GnRH) Antagonist at Different Periods of the Menstrual Cycle |
Polycystic Ovary Syndrome (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03951077 | — | P2 | completed | Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome |
Folliculogenesis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01403038 | — | P1 | completed | An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females |
Elagolix pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| MACE | NCT05038878 | P4 | terminated | Mild Autonomous Cortisol Excess | 4 | — |
| ELARIS EM-COC | NCT04333576 | P3 | active not recruiting | Endometriosis | 800 | — |
| PREGnant | NCT06375811 | P3 | active not recruiting | Infertility | 97 | — |
| PREGnant | NCT04173169 | P3 | completed | Infertility | 103 | PMID 35715184 |
| ELARIS EM-II | NCT01931670 | P3 | completed | Endometriosis | 815 | PMID 28525302 |
| ELARIS EM-I | NCT01620528 | P3 | completed | Endometriosis | 872 | PMID 32621325 |
| EFFECT | NCT04039204 | P2 | completed | Endometriosis | 10 | PMID 16359945 |
| SCHUMANN | NCT04614246 | P2 | terminated | Endometriosis | 215 | PMID 38890641 |
| HMB | NCT01817530 | P2 | completed | Heavy Uterine Bleeding | 571 | PMID 30303923 |
| NBI-56418 | NCT00619866 | P2 | completed | Endometriosis, Pain | 155 | — |
| PETAL | NCT00437658 | P2 | completed | Endometriosis | 252 | — |
Terminated and withdrawn Elagolix trials (3)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT05038878terminatedAn Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women
- NCT04614246terminatedStudy to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb
- NCT03343067terminatedA Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
All Elagolix trials (33)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT04333576 | ELARIS EM-COC | Study 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 Pain | P3 | active not recruiting | 800 | AbbVie | Aug 2020 |
| NCT06375811 | PREGnant | Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp | P3 | active not recruiting | 97 | Yale University | Mar 2024 |
| NCT03746535 | Cardiovascular Disease Risk in Women With Endometriosis | Early P1 | recruiting | 40 | Yale University | Jul 2022 | |
| NCT07532876 | Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain | P4 | enrolling by invitation | 90 | Pak Emirates Military Hospital | May 2026 | |
| NCT06798571 | Role of Menopause in Thermoregulation | P4 | recruiting | 24 | Penn State University | Mar 2025 | |
| NCT04856306 | Magical | Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L | — | unknown | 300 | Medstar Health Research Institute | Apr 2021 |
| NCT04173169 | PREGnant | Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis | P3 | completed | 103 | Yale University | Mar 2022 |
| NCT06076486 | A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated Pain | P3 | completed | 202 | Nanjing Chia-tai Tianqing Pharmaceutical | Sep 2023 | |
| NCT04445025 | Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis | Early P1 | completed | 30 | Colorado Center for Reproductive Medicine | Sep 2020 | |
| NCT03271489 | Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women | P3 | completed | 478 | AbbVie | Sep 2017 | |
| NCT05648669 | A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain | P3 | unknown | 336 | Qilu Pharmaceutical (Hainan) Co., Ltd. | Sep 2022 | |
| NCT03213457 | A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain | P3 | completed | 681 | AbbVie | Jul 2017 | |
| NCT04039204 | EFFECT | Elagolix for Fertility Enhancement Clinical Trial | P2 | completed | 10 | Wake Forest University Health Sciences | Jan 2022 |
| NCT05038878 | MACE | An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women | P4 | terminated | 4 | Icahn School of Medicine at Mount Sinai | Jul 2021 |
| NCT04614246 | SCHUMANN | Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb | P2 | terminated | 215 | Bayer | Jan 2021 |
| NCT04060992 | Hormonal Effects of the Oral Gonadotropin Releasing Hormone (GnRH) Antagonist at Different Periods of the Menstrual Cycle | P4 | unknown | 12 | University of Southern California | Oct 2019 | |
| NCT03886220 | A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women | P4 | completed | 82 | AbbVie | Apr 2019 | |
| NCT03951077 | Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome | P2 | completed | 118 | AbbVie | Aug 2019 | |
| NCT02925494 | An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids | P3 | completed | 433 | AbbVie | Sep 2016 | |
| NCT02691494 | Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study) | P3 | completed | 378 | AbbVie | Feb 2016 | |
| NCT02654054 | Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women | P3 | completed | 413 | AbbVie | Dec 2015 | |
| NCT03343067 | A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain | P3 | terminated | 11 | AbbVie | Dec 2017 | |
| NCT02143713 | Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain | P3 | completed | 496 | AbbVie | May 2014 | |
| NCT01931670 | ELARIS EM-II | A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain | P3 | completed | 815 | AbbVie | Sep 2013 |
| NCT01760954 | Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain | P3 | completed | 506 | AbbVie | Dec 2012 | |
| NCT01817530 | HMB | Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF) | P2 | completed | 571 | AbbVie | Apr 2013 |
| NCT01620528 | ELARIS EM-I | A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain | P3 | completed | 872 | AbbVie (prior sponsor, Abbott) | May 2012 |
| NCT01441635 | Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids | P2 | completed | 271 | AbbVie (prior sponsor, Abbott) | Sep 2011 | |
| NCT01403038 | An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females | P1 | completed | 216 | AbbVie (prior sponsor, Abbott) | Jun 2011 | |
| NCT00973973 | Efficacy and Safety Study of Elagolix in Women With Endometriosis | P2 | completed | 137 | AbbVie | Oct 2009 | |
| NCT00797225 | Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis | P2 | completed | 174 | AbbVie | Nov 2008 | |
| NCT00619866 | NBI-56418 | An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis | P2 | completed | 155 | AbbVie | Feb 2008 |
| NCT00437658 | PETAL | Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis | P2 | completed | 252 | AbbVie | Dec 2006 |
Elagolix clinical trials: frequently asked questions
- How many Elagolix clinical trials are there?
- 33 Elagolix clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 3 are actively recruiting participants. 22 are marked completed.
- Are Elagolix clinical trials recruiting in 2026?
- Yes — 3 Elagolix trials are actively recruiting in 2026, with 2 U.S. sites across 2 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Elagolix being studied for?
- Elagolix is being studied for Endometriosis, Uterine Fibroids, Heavy Menstrual Bleeding, Infertility, Heavy Uterine Bleeding and 10 more. The trials are grouped by indication on this page.
- What phase is Elagolix in?
- Elagolix clinical trials span 5 Phase 4, 15 Phase 3, 9 Phase 2, 1 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Elagolix clinical trials?
- The lead sponsor across the most Elagolix trials is AbbVie, with 12 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Elagolixas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: