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Last Updated: September 16, 2021

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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 in Endometriosis With NBI-56418; Placebo and Active Controlled Completed AbbVie (prior sponsor, Abbott) Phase 2 2008-11-01 This study is designed to evaluate the safety and beneficial effects of 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 NBI-56418.
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 Recruiting AbbVie Phase 3 2014-11-01 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) Recruiting AbbVie Phase 3 2014-06-01 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 Enrolling by invitation AbbVie Phase 3 2016-09-01 This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 or M12-817, 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 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 subjects. This is a study that assess the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain.
NCT03271489 ↗ Long-Term Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women Recruiting AbbVie Phase 3 2017-09-13 This is phase 3b study seeks to evaluate the safety and efficacy of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study is double-blinded in the first year and an open-label in the second year.
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 Not yet recruiting AbbVie Phase 3 2019-03-29 The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women.
>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 2
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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 125
Puerto Rico 3
Canada 2
Hungary 1
Russian Federation 1
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Trials by US State

Trials by US State for Elagolix Sodium
Location Trials
Georgia 5
Washington 5
Florida 5
Pennsylvania 4
Louisiana 4
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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 6
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Elagolix Sodium
Clinical Trial Phase Trials
Recruiting 4
Not yet recruiting 1
Completed 1
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Clinical Trial Sponsors for Elagolix Sodium

Sponsor Name

Sponsor Name for Elagolix Sodium
Sponsor Trials
AbbVie 6
AbbVie (prior sponsor, Abbott) 1
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Sponsor Type

Sponsor Type for Elagolix Sodium
Sponsor Trials
Industry 7
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