| Orilissa (elagolix) / AbbVie |
NCT01817530 / 2013-000082-37: Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF) |
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| Completed | 2b | 571 | NA | Elagolix placebo, Elagolix, ABT-620, 0.5 mg estradiol / 0.1 mg norethindrone acetate, Activelle, Activella, low dose (LD) E2/NETA, 1 mg estradiol / 0.5 mg norethindrone acetate, Activelle, Activella, standard dose (SD) E2/NETA, E2/NETA placebo | AbbVie | Heavy Uterine Bleeding, Uterine Fibroids | 06/15 | 12/15 | | |
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SCHUMANN, NCT04614246 / 2020-003131-16: Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb |
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| Terminated | 2b | 215 | Europe, Canada, Japan, US, RoW | BAY1817080, Elagolix, Placebo | Bayer | Endometriosis | 01/22 | 05/22 | | |
NCT01441635: Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids |
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| Completed | 2a | 271 | NA | Elagolix, ABT-620, Placebo, Estradiol/Norethindrone acetate (E2/NETA), Activella®, Estradiol, Estrace®, Progesterone, Prometrium® | AbbVie (prior sponsor, Abbott) | Heavy Uterine Bleeding, Uterine Fibroids | 11/13 | 05/14 | | |
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NCT00109512: Endometriosis Trial: Study of NBI-56418 in Endometriosis |
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| Completed | 2 | 76 | US | NBI-56418 (GnRH antagonist), placebo | Abbott | Endometriosis | 06/06 | 06/06 | | |
NCT00437658: Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis |
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| Completed | 2 | 252 | NA | Elagolix, NBI-56418, Orilissa™, Subcutaneous depot medroxyprogesterone acetate (DMPA-SC), depo-subQ provera 104™, Placebo to Elagolix, Placebo to DMPA-SC | AbbVie | Endometriosis | 11/08 | 11/08 | | |
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NCT00619866: An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis |
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| Completed | 2 | 155 | NA | Elagolix, NBI-56418, Orilissa™, placebo | AbbVie | Endometriosis, Pain | 04/09 | 08/09 | | |
| Completed | 2 | 174 | NA | Leuprorelin Acetate Depot, Prostap SR, Elagolix, NBI-56418, Orilissa™, Placebo to Elagolix, Placebo to Leuprorelin Acetate | AbbVie | Endometriosis | 02/10 | 02/10 | | |
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NCT00973973: Efficacy and Safety Study of Elagolix in Women With Endometriosis |
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| Completed | 2 | 137 | NA | Placebo, Elagolix, NBI-56418, Orilissa™ | AbbVie | Endometriosis, Pain | 09/10 | 09/10 | | |
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NCT03951077: Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome |
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| Completed | 2 | 118 | US | Elagolix, Orilissa, Placebo | AbbVie | Polycystic Ovary Syndrome | 02/21 | 02/21 | | |
| Completed | 2 | 10 | US | Elagolix, Orilissa, Ortho Cyclen | Wake Forest University Health Sciences, University of North Carolina, Chapel Hill, Stanford University | Endometriosis, Unexplained Infertility | 08/23 | 08/23 | | |
