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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR ELAGOLIX SODIUM

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Clinical Trials for Elagolix Sodium

Trial ID Title Status Sponsor Phase Summary
NCT00797225 Efficacy and Safety Study in Endometriosis With NBI-56418; Placebo and Active Controlled Completed AbbVie (prior sponsor, Abbott) Phase 2 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 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Elagolix Sodium

Condition Name

Condition Name for Elagolix Sodium
Intervention Trials
Uterine Fibroids 4
Heavy Menstrual Bleeding 4
Endometriosis 2
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Condition MeSH

Condition MeSH for Elagolix Sodium
Intervention Trials
Myofibroma 4
Menorrhagia 4
Leiomyoma 4
Hemorrhage 4
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Clinical Trial Locations for Elagolix Sodium

Trials by Country

Trials by Country for Elagolix Sodium
Location Trials
United States 123
Puerto Rico 3
Canada 2
Poland 1
Ukraine 1
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Trials by US State

Trials by US State for Elagolix Sodium
Location Trials
Florida 5
New York 4
Illinois 4
Indiana 4
Kentucky 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 5
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Elagolix Sodium
Clinical Trial Phase Trials
Recruiting 4
Completed 1
Enrolling by invitation 1
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Clinical Trial Sponsors for Elagolix Sodium

Sponsor Name

Sponsor Name for Elagolix Sodium
Sponsor Trials
AbbVie 5
AbbVie (prior sponsor, Abbott) 1
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Sponsor Type

Sponsor Type for Elagolix Sodium
Sponsor Trials
Industry 6
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