Product
Elagolix
Aliases
ABT-620, ABT-620 Elagolix sodium, Elagolix 200 MG, Elagolix placebo (5 other aliases)
Name
Orilissa
INN Name
Elagolix
FDA Approved
Yes
12 clinical trials
1 organization
6 indications
1 document
Indication
Heavy menstrual bleedingIndication
Uterine FibroidsIndication
EndometriosisIndication
infertilityIndication
InfertilityIndication
Mild Autonomous Cortisol ExcessClinical trial
A Phase 3b Study to Evaluate the Long-Term Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal WomenStatus: Active (not recruiting), Estimated PCD: 2024-07-11
Clinical trial
A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate in Subjects With Moderate to Severe Endometriosis-Associated PainStatus: Completed, Estimated PCD: 2020-03-27
Clinical trial
A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe PainStatus: Recruiting, Estimated PCD: 2024-12-05
Clinical trial
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Elagolix Tablets in Patients With Moderate or Severe Endometriosis-associated PainStatus: Recruiting, Estimated PCD: 2026-09-30
Clinical trial
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Elagolix in Patients With Moderate to Severe Endometriosis-Associated PainStatus: Recruiting, Estimated PCD: 2023-07-01
Clinical trial
A Randomized, Double-blind, Open for Active Comparator, Parallel-group, Multicenter Phase 2b Study to Assess the Efficacy and Safety of Three Different Doses of P2X3 Antagonist (BAY1817080) Versus Placebo and Elagolix 150 mg in Women With Symptomatic EndometriosisStatus: Terminated, Estimated PCD: 2022-01-17
Clinical trial
Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis - A Prospective Clinical TrialStatus: Active (not recruiting), Estimated PCD: 2025-05-31
Clinical trial
The Effect of Elagolix in Comparison to Leuprolide Acetate on in Vitro Fertilization (IVF) Cycle Outcomes After a Transfer of Euploid Embryos to Patients With Surgically Diagnosed Endometriosis: A Pilot TrialStatus: Active (not recruiting), Estimated PCD: 2024-09-30
Clinical trial
Elagolix for Fertility Enhancement Clinical Trial (EFFECT)Status: Completed, Estimated PCD: 2023-08-09
Clinical trial
Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis - A Prospective Clinical TrialStatus: Recruiting, Estimated PCD: 2026-06-30
Clinical trial
Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With EndometriosisStatus: Recruiting, Estimated PCD: 2025-08-30
Clinical trial
An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal WomenStatus: Recruiting, Estimated PCD: 2024-12-01
Document
DailyMed Label: OrilissaOrganization
AbbVie Inc.