| Orilissa (elagolix) / AbbVie |
NCT01620528: A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain |
|
|
| Completed | 3 | 872 | NA | elagolix, ABT-620, elagolix sodium, placebo | AbbVie (prior sponsor, Abbott) | Endometriosis | 11/14 | 09/15 | | |
|
|
|
|
NCT01760954: Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain |
|
|
| Completed | 3 | 506 | NA | Elagolix, Orilissa™ | AbbVie | Endometriosis | 05/15 | 04/16 | | |
NCT01931670 / 2011-004295-11: A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain |
|
|
| Completed | 3 | 815 | NA | placebo, Elagolix, ABT-620, elagolix sodium | AbbVie | Endometriosis | 01/16 | 12/16 | | |
|
|
|
|
|
NCT02143713 / 2013-001047-31: Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain |
|
|
| Completed | 3 | 496 | NA | Elagolix, Orilissa™ | AbbVie | Endometriosis | 06/16 | 05/17 | | |
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 | 3 | 413 | Canada, US | Elagolix, ABT-620, elagolix sodium, Placebo for Estradiol/Norethindrone Acetate, Estradiol/Norethindrone Acetate, E2/NETA, Placebo for Elagolix | AbbVie | Uterine Fibroids, Heavy Menstrual Bleeding | 01/18 | 12/18 | | |
|
|
|
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 | 3 | 378 | Canada, US | Elagolix, ABT-620, elagolix sodium, Placebo for Estradiol/Norethindrone Acetate, Estradiol/Norethindrone Acetate, E2/NETA, Placebo for Elagolix | AbbVie | Uterine Fibroids, Heavy Menstrual Bleeding | 02/18 | 01/19 | | |
|
|
NCT02925494: An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
|
|
| Completed | 3 | 433 | Canada, US | Estradiol/Norethindrone Acetate, Elagolix, ABT-620, elagolix sodium | AbbVie | Uterine Fibroids, Heavy Menstrual Bleeding | 05/18 | 03/19 | | |
NCT03343067: A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain |
|
|
| Terminated | 3 | 11 | US | elagolix, estradiol/norethindrone acetate (E2/NETA) | AbbVie | Endometriosis | 10/18 | 10/18 | | |
NCT03213457: A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain |
|
|
| Completed | 3 | 681 | Canada, US | Estradiol/Norethindrone Acetate, Activella, E2/NETA, Placebo for Elagolix, Elagolix, ABT-620, Elagolix Sodium, ORILISSA, Placebo for E2/NETA | AbbVie | Endometriosis | 03/20 | 12/23 | | |
NCT05648669: A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain |
|
|
| Recruiting | 3 | 336 | RoW | Elagolix, Elagolix placebo | Qilu Pharmaceutical (Hainan) Co., Ltd. | Endometriosis | 07/23 | 02/24 | | |
NCT03271489: Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women |
|
|
| Completed | 3 | 478 | US | Elagolix, Estradiol /norethindrone acetate (E2/NETA), E2/NETA Placebo, Elagolix Placebo | AbbVie | Heavy Menstrual Bleeding, Uterine Fibroids | 06/24 | 06/24 | | |
| Recruiting | 3 | 297 | US | Elagolix 200 MG, Orlissa, Placebo or SOC IVF | Yale University, University of Colorado, Denver, Northwestern University, University of North Carolina, Duke University, Johns Hopkins University | Infertility, Endometriosis | 06/26 | 09/26 | | |
NCT04173169: Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis |
|
|
| Completed | 3 | 103 | US | Elagolix 200 MG, Orlissa, Placebo or SOC IVF | Yale University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Colorado, Denver, Northwestern University, University of North Carolina | Infertility, Endometriosis | 05/25 | 05/25 | | |
ELARIS EM-COC, NCT04333576: Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain |
|
|
| Active, not recruiting | 3 | 800 | US | Elagolix, ABT-620, Orilissa, Placebo, Combined Oral Contraceptive | AbbVie | Endometriosis | 03/29 | 06/30 | | |
NCT06076486: A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated Pain |
|
|
| Completed | 3 | 202 | RoW | Elagolix, Elagolix placebo | Nanjing Chia-tai Tianqing Pharmaceutical | Endometriosis | 11/24 | 04/25 | | |
