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Last Updated: April 24, 2024

CLINICAL TRIALS PROFILE FOR ELAGOLIX SODIUM


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All Clinical Trials for Elagolix Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00797225 ↗ Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis Completed AbbVie Phase 2 2008-11-26 This study is designed to evaluate the safety and beneficial effects of elagolix (NBI-56418) compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed by an additional three months of treatment on elagolix.
NCT00797225 ↗ Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis Completed AbbVie (prior sponsor, Abbott) Phase 2 2008-11-26 This study is designed to evaluate the safety and beneficial effects of elagolix (NBI-56418) compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed by an additional three months of treatment on elagolix.
NCT01931670 ↗ A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain Completed AbbVie Phase 3 2013-09-09 A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.
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 Completed AbbVie Phase 3 2015-12-22 This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
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) Completed AbbVie Phase 3 2016-02-03 This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
NCT02925494 ↗ An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Completed AbbVie Phase 3 2016-09-14 This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.
NCT03213457 ↗ A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain Active, not recruiting AbbVie Phase 3 2017-07-07 The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Elagolix Sodium

Condition Name

Condition Name for Elagolix Sodium
Intervention Trials
Uterine Fibroids 5
Heavy Menstrual Bleeding 4
Endometriosis 3
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Condition MeSH

Condition MeSH for Elagolix Sodium
Intervention Trials
Leiomyoma 5
Hemorrhage 5
Myofibroma 5
Menorrhagia 5
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Clinical Trial Locations for Elagolix Sodium

Trials by Country

Trials by Country for Elagolix Sodium
Location Trials
United States 215
Canada 8
Puerto Rico 5
Hungary 2
Poland 2
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Trials by US State

Trials by US State for Elagolix Sodium
Location Trials
Illinois 7
Pennsylvania 7
Georgia 7
Louisiana 7
Massachusetts 7
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Clinical Trial Progress for Elagolix Sodium

Clinical Trial Phase

Clinical Trial Phase for Elagolix Sodium
Clinical Trial Phase Trials
Phase 3 7
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Elagolix Sodium
Clinical Trial Phase Trials
Completed 6
Active, not recruiting 2
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Clinical Trial Sponsors for Elagolix Sodium

Sponsor Name

Sponsor Name for Elagolix Sodium
Sponsor Trials
AbbVie 8
AbbVie (prior sponsor, Abbott) 1
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Sponsor Type

Sponsor Type for Elagolix Sodium
Sponsor Trials
Industry 9
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