elagolix: Clinical Trials

34 trials of elagolix, newest first

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25 completed, 3 terminated, 2 active not recruiting, 2 unknown. 15 Phase 3, 9 Phase 2, 6 Phase 4, 2 Early Phase 1, 1 Not applicable.

By phase and status

PhaseTrialsStatus
Phase 315Completed 11, Active not recruiting 2, Terminated 1, Unknown 1
Phase 29Completed 8, Terminated 1
Phase 46Completed 2, Enrolling by invitation 1, Recruiting 1, Terminated 1, Unknown 1
Early Phase 12Completed 2
Not applicable1Completed 1
Phase 11Completed 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain
Elagolix, Oral Contraceptive (OC) - Endometriosis (Diagnosis)
Phase 4Enrolling by invitationPak Emirates Military Hospital902026-05-012026-04-16
Effect of Elagolix in Symptomatic Endometrioma in Comparison to Combined Oral Contraceptive Pill.
tab Elagolix 150mg, Combined oral contraceptive pill (ethinyl estradiol,30mcg+desogestrel,150mcg) tablet - Endometrioma
Not applicableCompletedMst.Sumyara Khatun602025-04-172026-08-13
Role of Menopause in Thermoregulation
Elagolix Oral Tablet, Estradiol patch, cellulose placebo - Menopause, Aging
Phase 4RecruitingPenn State University242025-03-012026-10-02
Brain Blood Flow Responses to Stress: Sex Differences
Indomethacin, Placebo, Orilissa - Cerebrovascular Disorders
Phase 4CompletedUniversity of Wisconsin, Madison222024-07-242026-09-24
Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp
Elagolix 200 MG, Placebo or SOC IVF - Infertility, Endometriosis
Phase 3Active not recruitingYale University972024-03-162026-06-05
A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated Pain
Elagolix, Elagolix placebo - Endometriosis
Phase 3CompletedNanjing Chia-tai Tianqing Pharmaceutical2022023-09-142025-09-23
A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain
Elagolix, Elagolix placebo - Endometriosis
Phase 3UnknownQilu Pharmaceutical (Hainan) Co., Ltd.3362022-09-042022-12-13
Cardiovascular Disease Risk in Women With Endometriosis
Elagolix - Endometriosis
Early Phase 1CompletedYale University212022-07-012026-10-16
Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis
Elagolix 200 MG, Placebo or SOC IVF - Infertility, Endometriosis
Phase 3CompletedYale University1032022-03-152026-06-12
Elagolix for Fertility Enhancement Clinical Trial
Elagolix, Ortho Cyclen - Endometriosis, Unexplained Infertility
Phase 2CompletedWake Forest University Health Sciences102022-01-152024-07-26
An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women
Elagolix - Mild Autonomous Cortisol Excess
Phase 4TerminatedIcahn School of Medicine at Mount Sinai42021-07-062025-03-18
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
BAY1817080, Elagolix, Placebo - Endometriosis
Phase 2TerminatedBayer2152021-01-292023-08-01
Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis
Elagolix 200 MG, Leuprolide Acetate 3.75 MG/ML, Lab work - Infertility, Endometriosis
Early Phase 1CompletedColorado Center for Reproductive Medicine302020-09-012025-02-20
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
Elagolix, Placebo, Combined Oral Contraceptive - Endometriosis
Phase 3Active not recruitingAbbVie8002020-08-102026-06-12
Hormonal Effects of the Oral Gonadotropin Releasing Hormone (GnRH) Antagonist at Different Periods of the Menstrual Cycle
Elagolix 200 MG Oral Tablet [Orilissa] - Ovulation; Failure or Lack of
Phase 4UnknownUniversity of Southern California122019-10-012019-08-19
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Elagolix, Placebo - Polycystic Ovary Syndrome
Phase 2CompletedAbbVie1182019-08-122022-06-08
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Elagolix, Placebo - Uterine Fibroids
Phase 4CompletedAbbVie822019-04-122022-03-31
A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
elagolix, estradiol/norethindrone acetate (E2/NETA) - Endometriosis
Phase 3TerminatedAbbVie112017-12-272019-11-27
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
Elagolix, Estradiol /norethindrone acetate (E2/NETA), E2/NETA Placebo - Heavy Menstrual Bleeding, Uterine Fibroids
Phase 3CompletedAbbVie4782017-09-132025-07-22
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
Estradiol/Norethindrone Acetate, Placebo for Elagolix, Elagolix - Endometriosis
Phase 3CompletedAbbVie6812017-07-072024-12-20

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Conditions studied

Endometriosis (22)  ·  Dysmenorrhea (7)  ·  Leiomyoma (7)  ·  Menorrhagia (7)  ·  Infertility (3)  ·  Pain (2)  ·  Anovulation (1)  ·  Cerebrovascular Disorders (1)  ·  Disease (1)  ·  Dyspareunia (1)  ·  Heat Stress Disorders (1)  ·  Pelvic Pain (1)  ·  Polycystic Ovary Syndrome (1)

Sponsors

AbbVie (17)  ·  AbbVie (prior sponsor, Abbott) (3)  ·  Yale University (3)  ·  Bayer (1)  ·  Colorado Center for Reproductive Medicine (1)  ·  Icahn School of Medicine at Mount Sinai (1)  ·  Mst.Sumyara Khatun (1)  ·  Nanjing Chia-tai Tianqing Pharmaceutical (1)  ·  Pak Emirates Military Hospital (1)  ·  Penn State University (1)  ·  Qilu Pharmaceutical (Hainan) Co., Ltd. (1)  ·  University of Southern California (1)  ·  University of Wisconsin, Madison (1)  ·  Wake Forest University Health Sciences (1)

Countries

United States (19)  ·  Puerto Rico (8)  ·  Canada (5)  ·  China (3)  ·  Austria (1)  ·  Bangladesh (1)  ·  Belgium (1)  ·  Bulgaria (1)  ·  Czechia (1)  ·  Estonia (1)  ·  Finland (1)  ·  Germany (1)  ·  Greece (1)  ·  Hungary (1)  ·  Italy (1)

Top investigators

Emily Jungheim, MD (2)  ·  Heping Zhang, PhD (2)  ·  Hugh Taylor, MD (2)  ·  Nanette Santoro, MD (2)  ·  Steven Young, MD, PhD (2)  ·  Abisola Tepede, PharmD (1)  ·  Alice C Levine (1)  ·  Bruce A Lessey, MD, PhD (1)  ·  Charlotte Owens, MD (1)  ·  David Weinberg, PhD (1)  ·  Eric Surrey, MD (1)  ·  Jim Segars, MD (1)  ·  Kristof Chwalisz, MD, PhD, MD (1)

Results publications

PMID 34878624, PMID 29476499, PMID 28525302, PMID 32621325, PMID 32945631, PMID 33650259, PMID 33963686, PMID 31654294, PMID 30724096, PMID 30992150, PMID 31227284, PMID 31971678, PMID 32769633, PMID 33066973, PMID 33564263, PMID 34134684, PMID 34553161, PMID 34582715, PMID 39381651, PMID 11163814, PMID 11726570, PMID 12372443, PMID 2005218, PMID 22500852, PMID 25395741, PMID 27733082, PMID 28323948, PMID 29889764, PMID 30303923, PMID 30383729, PMID 31069056, PMID 31650182, PMID 32702363, PMID 34363198, PMID 34435897, PMID 34553156, PMID 34978027, PMID 3543765, PMID 35715184, PMID 37398623, PMID 37769311, PMID 38890641

NIH funding

R01HD100336 (1), R01HL150361 (1), R01HL161000 (1)