20 completed. 20 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 20 | Completed 20 |
| Phase 2 | 2 | Completed 2 |
Follow Uterine Fibroids: new trials by email Literature Review of Uterine Fibroids trials Research Report on Uterine Fibroids
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Relugolix, Estradiol/norethindrone acetate, Placebo for relugolix - Uterine Leiomyoma, Uterine Fibroids | Phase 3 | Completed | Myovant Sciences GmbH | 229 | 2018-10-16 | 2024-06-25 |
| 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 Elagolix, Estradiol /norethindrone acetate (E2/NETA), E2/NETA Placebo - Heavy Menstrual Bleeding, Uterine Fibroids | Phase 3 | Completed | AbbVie | 478 | 2017-09-13 | 2025-07-22 |
| Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids OBE2109, Placebo to match OBE2109, Placebo to match Add-back - Uterine Fibroids, Heavy Menstrual Bleeding | Phase 3 | Completed | ObsEva SA | 511 | 2017-05-23 | 2021-03-05 |
| Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids OBE2109, Placebo to match OBE2109, Placebo to match Add-back - Uterine Fibroids, Heavy Menstrual Bleeding | Phase 3 | Completed | ObsEva SA | 526 | 2017-04-20 | 2021-06-09 |
| An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Estradiol/Norethindrone Acetate, Elagolix - Uterine Fibroids, Heavy Menstrual Bleeding | Phase 3 | Completed | AbbVie | 433 | 2016-09-14 | 2021-07-13 |
| A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids Relugolix, Relugolix placebo - Uterine Fibroids | Phase 3 | Completed | Takeda | 65 | 2016-03-26 | 2019-03-22 |
| A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids Relugolix, Relugolix Placebo, Leuprorelin - Uterine Fibroids | Phase 3 | Completed | Takeda | 281 | 2016-03-05 | 2019-03-22 |
| 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) Elagolix, Placebo for Estradiol/Norethindrone Acetate, Estradiol/Norethindrone Acetate - Uterine Fibroids, Heavy Menstrual Bleeding | Phase 3 | Completed | AbbVie | 378 | 2016-02-03 | 2021-07-13 |
| 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 Elagolix, Placebo for Estradiol/Norethindrone Acetate, Estradiol/Norethindrone Acetate - Uterine Fibroids, Heavy Menstrual Bleeding | Phase 3 | Completed | AbbVie | 413 | 2015-12-22 | 2020-06-29 |
| PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata Ulipristal Acetate - open label - Uterine Fibroids | Phase 3 | Completed | PregLem SA | 64 | 2012-07-01 | 2016-01-08 |
| PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata PGL4001 5 mg, PGL4001 10 mg - Uterine Fibroids | Phase 3 | Completed | PregLem SA | 451 | 2012-06-01 | 2019-09-04 |
| PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study) PGL4001, placebo, drug free period, PGL4001, progestin, drug free period - Uterine Fibroids | Phase 3 | Completed | PregLem SA | 132 | 2011-01-01 | 2016-01-13 |
| PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata PGL4001, placebo, PGL4001, progestin - Uterine Fibroids | Phase 3 | Completed | PregLem SA | 209 | 2010-07-01 | 2016-01-15 |
| Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids Mifepristone - Uterine Fibroids | Phase 2 / Phase 3 | Completed | Mediterranea Medica S. L. | 100 | 2008-05-01 | 2014-10-17 |
| Mifepristone for Treatment of Uterine Fibroids Mifepristone - Uterine Fibroids | Phase 2 / Phase 3 | Completed | Mediterranea Medica S. L. | 200 | 2007-01-01 | 2009-04-23 |
| MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication ExAblate Enhanced Sonication - Uterine Leiomyoma, Uterine Fibroids | Phase 3 | Completed | InSightec | 50 | 2006-10-01 | 2019-02-05 |
| MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation ExAblate 2000 - Uterine Fibroids, Uterine Leiomyomas | Phase 3 | Completed | InSightec | 15 | 2006-02-01 | 2018-12-20 |
| Study of Asoprisnil in the Treatment of Uterine Fibroids. Asoprisnil - Fibroid Uterus, Leiomyoma | Phase 3 | Completed | Abbott | 149 | 2004-11-01 | 2008-05-28 |
| Safety of Treatment of Uterine Fibroids With Asoprisnil Asoprisnil - Fibroid Uterus, Leiomyoma | Phase 3 | Completed | Abbott | 166 | 2004-04-01 | 2008-05-29 |
| A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Asoprisnil, Placebo - Fibroid Uterus, Leiomyoma | Phase 3 | Completed | Abbott | 239 | 2003-09-01 | 2008-05-29 |
Leiomyoma (20) · Menorrhagia (10) · Metrorrhagia (3) · Myofibroma (3) · Uterine Hemorrhage (3) · Neoplasms (1)
Neoplasms by Histologic Type (20) · Neoplasms, Connective and Soft Tissue (20) · Neoplasms, Muscle Tissue (20) · Neoplasms (19) · Female Urogenital Diseases (10) · Female Urogenital Diseases and Pregnancy Complications (10) · Genital Diseases (10) · Genital Diseases, Female (10) · Hemorrhage (10) · Menstruation Disturbances (10) · Pathologic Processes (10) · Pathological Conditions, Signs and Symptoms (10) · Urogenital Diseases (10) · Uterine Diseases (10) · Uterine Hemorrhage (7)
elagolix (4) · estradiol, norethindrone drug combination (4) · Estradiol (3) · Norethindrone Acetate (3) · asoprisnil (3) · relugolix (3) · ulipristal acetate (3) · Mifepristone (2) · Progestins (2) · linzagolix (2) · Leuprolide (1)
AbbVie (4) · PregLem SA (4) · Abbott (3) · InSightec (2) · Mediterranea Medica S. L. (2) · ObsEva SA (2) · Takeda (2) · Myovant Sciences GmbH (1)
United States (9) · Poland (5) · Belgium (4) · Canada (4) · Austria (3) · Czechia (3) · Hungary (3) · Puerto Rico (3) · Spain (3) · Cuba (2) · Italy (2) · Japan (2) · Latvia (2) · Lithuania (2) · Romania (2)
Anne Roberts, M.D. (2) · George Holland, M.D. (2) · Mark Shaman, M.D. (2) · ObsEva SA (2) · Robert Min, M.D. (2) · Carbonell Josep Ll., MD (1) · David Gianfelice, M.D. (1) · Elke Bestel, Dr (1) · Josep LL. Carbonell, MD (1) · Pablo Arrigada, MD (1)
PMID 34878624, PMID 24630081, PMID 31971678, PMID 33650259, PMID 34553161, PMID 34582715, PMID 36116480, PMID 39381651, PMID 40326221, PMID 40543832, PMID 25542821, PMID 26477496, PMID 30741797, PMID 31594635, PMID 32702363, PMID 37666383
2018 (1)