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ClinicalTrials.gov public records Last synced Oct 18, 2026, 5:53 AM EDT

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Showing 1–23 of 23 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Elagolix Clear all
Completed Phase 3 Interventional Results available

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)

NCT02691494
View directory record Official record
Conditions
Uterine Fibroids, Heavy Menstrual Bleeding
Interventions
Elagolix, Placebo for Estradiol/Norethindrone Acetate, Estradiol/Norethindrone Acetate, Placebo for Elagolix
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 51 Years · Female only
Enrollment
378 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
103
States / cities
Birmingham, Alabama • Dothan, Alabama • Fairhope, Alabama + 89 more
Source: ClinicalTrials.gov public record
Updated Jul 13, 2021 · Synced Oct 18, 2026, 5:53 AM EDT
Not listed No phase listed Observational Accepts healthy volunteers

Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L

NCT04856306
View directory record Official record
Conditions
Heavy Menstrual Bleeding, Fibroid Uterus
Interventions
Groups 1 and 2 myomectomy and uterine artery embolization, respectively, are surgical/procedure, Elagolix Oral Product
Other · Drug
Lead sponsor
Medstar Health Research Institute
Other
Eligibility
18 Years and older · Female only
Enrollment
300 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2025
U.S. locations
1
States / cities
Washington D.C., District of Columbia
Source: ClinicalTrials.gov public record
Updated May 5, 2022 · Synced Oct 18, 2026, 5:53 AM EDT
Terminated Phase 2 Interventional Results available

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

NCT04614246
View directory record Official record
Conditions
Endometriosis
Interventions
BAY1817080, Elagolix, Placebo
Drug
Lead sponsor
Bayer
Industry
Eligibility
18 Years and older · Female only
Enrollment
215 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
47
States / cities
Birmingham, Alabama • Mobile, Alabama • Phoenix, Arizona + 36 more
Source: ClinicalTrials.gov public record
Updated Aug 1, 2023 · Synced Oct 18, 2026, 5:53 AM EDT
Terminated Phase 4 Interventional Results available

An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women

NCT05038878
View directory record Official record
Conditions
Mild Autonomous Cortisol Excess
Interventions
Elagolix
Drug
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Eligibility
Female only
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Mar 18, 2025 · Synced Oct 18, 2026, 5:53 AM EDT
Recruiting Phase 4 Interventional Accepts healthy volunteers

Role of Menopause in Thermoregulation

NCT06798571
View directory record Official record
Conditions
Menopause, Aging
Interventions
Elagolix Oral Tablet, Estradiol patch, cellulose placebo, placebo patch
Drug · Other
Lead sponsor
Penn State University
Other
Eligibility
42 Years to 64 Years · Female only
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2026
U.S. locations
1
States / cities
University Park, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 2, 2026 · Synced Oct 18, 2026, 5:53 AM EDT
Completed Early Phase 1 Interventional Accepts healthy volunteers Results available

Cardiovascular Disease Risk in Women With Endometriosis

NCT03746535
View directory record Official record
Conditions
Endometriosis
Interventions
Elagolix
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
21 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2025
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Oct 16, 2026 · Synced Oct 18, 2026, 5:53 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03271489
View directory record Official record
Conditions
Heavy Menstrual Bleeding, Uterine Fibroids
Interventions
Elagolix, Estradiol /norethindrone acetate (E2/NETA), E2/NETA Placebo, Elagolix Placebo
Drug · Other
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 50 Years · Female only
Enrollment
478 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
155
States / cities
Birmingham, Alabama • Dothan, Alabama • Fairhope, Alabama + 112 more
Source: ClinicalTrials.gov public record
Updated Jul 22, 2025 · Synced Oct 18, 2026, 5:53 AM EDT
Completed Phase 3 Interventional Results available

An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

NCT02925494
View directory record Official record
Conditions
Uterine Fibroids, Heavy Menstrual Bleeding
Interventions
Estradiol/Norethindrone Acetate, Elagolix
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 51 Years · Female only
Enrollment
433 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
121
States / cities
Birmingham, Alabama • Dothan, Alabama • Fairhope, Alabama + 90 more
Source: ClinicalTrials.gov public record
Updated Jul 13, 2021 · Synced Oct 18, 2026, 5:53 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females

NCT01403038
View directory record Official record
Conditions
Folliculogenesis
Interventions
elagolix
Drug
Lead sponsor
AbbVie (prior sponsor, Abbott)
Industry
Eligibility
18 Years to 40 Years · Female only
Enrollment
216 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2012
U.S. locations
20
States / cities
Colorado Springs, Colorado • Denver, Colorado • Lonetree, Colorado + 14 more
Source: ClinicalTrials.gov public record
Updated Jan 8, 2013 · Synced Oct 18, 2026, 5:53 AM EDT
Active, not recruiting Phase 3 Interventional

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

NCT04333576
View directory record Official record
Conditions
Endometriosis
Interventions
Elagolix, Placebo, Combined Oral Contraceptive
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 49 Years · Female only
Enrollment
800 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
176
States / cities
Anniston, Alabama • Birmingham, Alabama • Dothan, Alabama + 134 more
Source: ClinicalTrials.gov public record
Updated Jun 12, 2026 · Synced Oct 18, 2026, 5:53 AM EDT
Completed Phase 3 Interventional Results available

Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis

NCT04173169
View directory record Official record
Conditions
Infertility, Endometriosis
Interventions
Elagolix 200 MG, Placebo or SOC IVF
Drug · Other
Lead sponsor
Yale University
Other
Eligibility
18 Years to 40 Years · Female only
Enrollment
103 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
5
States / cities
Aurora, Colorado • New Haven, Connecticut • Chicago, Illinois + 2 more
Source: ClinicalTrials.gov public record
Updated Jun 12, 2026 · Synced Oct 18, 2026, 5:53 AM EDT
Completed Phase 3 Interventional Results available

A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain

NCT03213457
View directory record Official record
Conditions
Endometriosis
Interventions
Estradiol/Norethindrone Acetate, Placebo for Elagolix, Elagolix, Placebo for E2/NETA
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 49 Years · Female only
Enrollment
681 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
188
States / cities
Birmingham, Alabama • Fairhope, Alabama • Mobile, Alabama + 140 more
Source: ClinicalTrials.gov public record
Updated Dec 20, 2024 · Synced Oct 18, 2026, 5:53 AM EDT
Terminated No phase listed Observational

A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules

NCT05026502
View directory record Official record
Conditions
Heavy Menstrual Bleeding, Uterine Fibroids
Interventions
Not listed
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 51 Years · Female only
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Aug 14, 2023 · Synced Oct 18, 2026, 5:53 AM EDT
Active, not recruiting Phase 3 Interventional

Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp

NCT06375811
View directory record Official record
Conditions
Infertility, Endometriosis
Interventions
Elagolix 200 MG, Placebo or SOC IVF
Drug · Other
Lead sponsor
Yale University
Other
Eligibility
18 Years to 40 Years · Female only
Enrollment
97 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
5
States / cities
Aurora, Colorado • New Haven, Connecticut • Chicago, Illinois + 2 more
Source: ClinicalTrials.gov public record
Updated Jun 5, 2026 · Synced Oct 18, 2026, 5:53 AM EDT
Terminated No phase listed Observational

A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules

NCT04464187
View directory record Official record
Conditions
Endometriosis, Uterine Fibrioids
Interventions
Not listed
Lead sponsor
AbbVie
Industry
Eligibility
Female only
Enrollment
173 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Sep 15, 2025 · Synced Oct 18, 2026, 5:53 AM EDT
Completed Phase 4 Interventional Results available

A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

NCT03886220
View directory record Official record
Conditions
Uterine Fibroids
Interventions
Elagolix, Placebo
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 51 Years · Female only
Enrollment
82 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
45
States / cities
Birmingham, Alabama • Searcy, Arkansas • La Mesa, California + 35 more
Source: ClinicalTrials.gov public record
Updated Mar 31, 2022 · Synced Oct 18, 2026, 5:53 AM EDT
Withdrawn No phase listed Observational

A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

NCT06058728
View directory record Official record
Conditions
Uterine Fibroids (UF)
Interventions
Not listed
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 50 Years · Female only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Arlington, Virginia
Source: ClinicalTrials.gov public record
Updated Sep 17, 2025 · Synced Oct 18, 2026, 5:53 AM EDT
Terminated Phase 3 Interventional Results available

A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain

NCT03343067
View directory record Official record
Conditions
Endometriosis
Interventions
elagolix, estradiol/norethindrone acetate (E2/NETA)
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 49 Years · Female only
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
37
States / cities
Anniston, Alabama • Tucson, Arizona • Little Rock, Arkansas + 30 more
Source: ClinicalTrials.gov public record
Updated Nov 27, 2019 · Synced Oct 18, 2026, 5:53 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

Brain Blood Flow Responses to Stress: Sex Differences

NCT06253702
View directory record Official record
Conditions
Cerebrovascular Disorders
Interventions
Indomethacin, Placebo, Orilissa, Testosterone gel, Anastrozole, Estradiol
Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years to 40 Years
Enrollment
22 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2025
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Sep 24, 2026 · Synced Oct 18, 2026, 5:53 AM EDT
Completed Phase 2 Interventional Results available

Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

NCT03951077
View directory record Official record
Conditions
Polycystic Ovary Syndrome
Interventions
Elagolix, Placebo
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 35 Years · Female only
Enrollment
118 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
50
States / cities
Birmingham, Alabama • Mobile, Alabama • San Diego, California + 43 more
Source: ClinicalTrials.gov public record
Updated Jun 8, 2022 · Synced Oct 18, 2026, 5:53 AM EDT
Completed Phase 3 Interventional Results available

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

NCT02654054
View directory record Official record
Conditions
Uterine Fibroids, Heavy Menstrual Bleeding
Interventions
Elagolix, Placebo for Estradiol/Norethindrone Acetate, Estradiol/Norethindrone Acetate, Placebo for Elagolix
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 51 Years · Female only
Enrollment
413 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
92
States / cities
Birmingham, Alabama • Mobile, Alabama • Costa Mesa, California + 79 more
Source: ClinicalTrials.gov public record
Updated Jun 29, 2020 · Synced Oct 18, 2026, 5:53 AM EDT
Completed Phase 2 Interventional Results available

Elagolix for Fertility Enhancement Clinical Trial

NCT04039204
View directory record Official record
Conditions
Endometriosis, Unexplained Infertility
Interventions
Elagolix, Ortho Cyclen
Drug
Lead sponsor
Wake Forest University Health Sciences
Other
Eligibility
18 Years to 42 Years · Female only
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Winston-Salem, North Carolina
Source: ClinicalTrials.gov public record
Updated Jul 26, 2024 · Synced Oct 18, 2026, 5:53 AM EDT
Completed Early Phase 1 Interventional Accepts healthy volunteers

Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis

NCT04445025
View directory record Official record
Conditions
Infertility, Endometriosis
Interventions
Elagolix 200 MG, Leuprolide Acetate 3.75 MG/ML, Lab work
Drug · Diagnostic Test
Lead sponsor
Colorado Center for Reproductive Medicine
Other
Eligibility
21 Years to 42 Years · Female only
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2024
U.S. locations
1
States / cities
Lone Tree, Colorado
Source: ClinicalTrials.gov public record
Updated Feb 20, 2025 · Synced Oct 18, 2026, 5:53 AM EDT