20 completed, 13 terminated, 3 recruiting, 2 unknown. 41 Phase 3, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 41 | Completed 20, Terminated 13, Recruiting 3, Unknown 2, Withdrawn 2, Active not recruiting 1 |
| Phase 2 | 5 | Completed 2, Terminated 2, Unknown 1 |
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 |
|---|---|---|---|---|---|---|
| to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia KLH-2109+ Leurprorelin acetate Placebo, KLH-2109 Placebo + Leurprorelin acetate - Menorrhagia, Uterine Fibroids | Phase 3 | Recruiting | JW Pharmaceutical | 254 | 2026-02-03 | 2026-05-01 |
| Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Relugolix, Relugolix placebo - Heavy Menstrual Bleeding, Uterine Fibroids | Phase 3 | Recruiting | Qilu Pharmaceutical Co., Ltd. | 120 | 2024-01-15 | 2026-02-02 |
| A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis Relugolix Combination Tablet - Uterine Fibroids, Endometriosis | Phase 3 | Recruiting | Sumitomo Pharma Switzerland GmbH | 1000 | 2023-08-14 | 2025-08-06 |
| Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids. BG2109, Placebo for BG2109, Placebo for add-back therapy - Uterine Fibroids, Heavy Menstrual Bleeding | Phase 3 | Unknown | Bio Genuine (Shanghai) Biotech Co., Ltd. | 312 | 2022-12-16 | 2023-03-21 |
| Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy, Myomectomy (laparoscopic or open surgical) - Uterine Fibroids | Phase 3 | Active not recruiting | Krankenhaus Nordwest | 127 | 2020-07-15 | 2024-11-13 |
| Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Vilaprisan (BAY1002670), Placebo - Uterine Fibroids | Phase 3 | Withdrawn | Bayer | 2018-10-27 | 2020-01-18 | |
| 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 |
| Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4) Vilaprisan (BAY1002670), Placebo - Uterine Fibroids | Phase 3 | Terminated | Bayer | 103 | 2018-01-24 | 2022-06-30 |
| Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3) Vilaprisan (BAY1002670), Placebo - Uterine Fibroids | Phase 3 | Terminated | Bayer | 93 | 2018-01-17 | 2023-05-03 |
| 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 |
| A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Vilaprisan (BAY1002670) - Uterine Fibroids | Phase 3 | Terminated | Bayer | 766 | 2017-07-31 | 2024-10-18 |
| Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Vilaprisan (BAY1002670), Standard of care - Uterine Fibroids | Phase 3 | Terminated | Bayer | 1272 | 2017-06-30 | 2025-07-28 |
| 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 |
| Study of Volume Reduction of Uterine Fibroids After Embolization or Microwave Treatment Microwave treatment, uterine artery embolization - Uterine Fibroids | Phase 2 / Phase 3 | Unknown | Karolinska Institutet | 36 | 2017-01-23 | 2018-10-02 |
| 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 |
Showing 20 of 41. Sign in to see all of them.
Leiomyoma (41) · Menorrhagia (15) · Myofibroma (5) · Metrorrhagia (3) · Uterine Hemorrhage (3) · Anemia (2) · Endometriosis (1) · Neoplasms (1)
Neoplasms by Histologic Type (41) · Neoplasms, Connective and Soft Tissue (41) · Neoplasms, Muscle Tissue (41) · Neoplasms (40) · Female Urogenital Diseases (16) · Female Urogenital Diseases and Pregnancy Complications (16) · Genital Diseases (16) · Genital Diseases, Female (16) · Urogenital Diseases (16) · Hemorrhage (15) · Menstruation Disturbances (15) · Pathologic Processes (15) · Pathological Conditions, Signs and Symptoms (15) · Uterine Diseases (15) · Uterine Hemorrhage (12)
telapristone acetate (7) · relugolix (5) · vilaprisan (5) · elagolix (4) · estradiol, norethindrone drug combination (4) · ulipristal acetate (4) · Estradiol (3) · Norethindrone Acetate (3) · asoprisnil (3) · Mifepristone (2) · Progestins (2) · Sugars (2) · linzagolix (2) · Laparoscopy (1) · Leuprolide (1)
Repros Therapeutics Inc. (7) · Bayer (5) · AbbVie (4) · PregLem SA (4) · Abbott (3) · Mediterranea Medica S. L. (3) · InSightec (2) · ObsEva SA (2) · Takeda (2) · Bio Genuine (Shanghai) Biotech Co., Ltd. (1) · Instituto Valenciano de Infertilidad, IVI VALENCIA (1) · JW Pharmaceutical (1) · Karolinska Institutet (1) · Krankenhaus Nordwest (1) · Myovant Sciences GmbH (1)
United States (20) · Czechia (7) · Poland (7) · Canada (6) · Belgium (5) · Japan (5) · Spain (5) · Austria (4) · China (4) · Hungary (4) · Bulgaria (3) · Cuba (3) · Germany (3) · Italy (3) · Lithuania (3)
Andre van As, MD, PhD (2) · Anne Roberts, M.D. (2) · George Holland, M.D. (2) · Mark Shaman, M.D. (2) · ObsEva SA (2) · Robert Min, M.D. (2) · Amanda Yunker, D.O. (1) · Aytekin Oto, MD (1) · Carbonell Josep Ll., MD (1)
PMID 34878624, PMID 24630081, PMID 31971678, PMID 33650259, PMID 34553161, PMID 34582715, PMID 36116480, PMID 39381651, PMID 40326221, PMID 40543832, PMID 23984082, PMID 25542821, PMID 26477496, PMID 30741797, PMID 31594635, PMID 32702363, PMID 35134317, PMID 37437885, PMID 37666383
2016 (3), 2017 (1), 2018 (1)