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 |
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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. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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