15 completed. 15 Phase 2, 2 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 15 | Completed 15 |
| Phase 3 | 2 | Completed 2 |
| Phase 1 | 1 | Completed 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 |
|---|---|---|---|---|---|---|
| A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids Telapristone Acetate, Placebo - Uterine Fibroids | Phase 2 | Completed | Repros Therapeutics Inc. | 43 | 2015-03-16 | 2019-06-19 |
| Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids Placebo, Telapristone Acetate - Uterine Fibroids | Phase 2 | Completed | Repros Therapeutics Inc. | 42 | 2015-02-12 | 2019-06-25 |
| Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF) Elagolix placebo, Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate - Heavy Uterine Bleeding, Uterine Fibroids | Phase 2 | Completed | AbbVie | 571 | 2013-04-08 | 2020-07-21 |
| Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Proellex 12 mg, Proellex 24 mg - Uterine Fibroids | Phase 2 | Completed | Repros Therapeutics Inc. | 40 | 2012-09-01 | 2014-04-16 |
| Extension of Study ZPV-200 telepristone acetate 12 mg, telepristone acetate 3 mg, telepristone acetate 6 mg - Uterine Fibroids | Phase 2 | Completed | Repros Therapeutics Inc. | 48 | 2012-09-01 | 2014-04-16 |
| Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids Proellex - Uterine Fibroids | Phase 2 | Completed | Repros Therapeutics Inc. | 40 | 2012-02-01 | 2014-08-29 |
| Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids TAK-385, Placebo - Uterine Fibroids | Phase 2 | Completed | Takeda | 216 | 2011-10-01 | 2013-01-21 |
| Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids Elagolix, Placebo, Estradiol/Norethindrone acetate (E2/NETA) - Heavy Uterine Bleeding, Uterine Fibroids | Phase 2 | Completed | AbbVie (prior sponsor, Abbott) | 271 | 2011-09-08 | 2021-07-13 |
| Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids Philips MR guided HIFU system - Uterine Fibroids, Uterine Leiomyomata | Phase 1 / Phase 2 | Completed | Philips Healthcare | 11 | 2009-01-01 | 2012-12-04 |
| 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 |
| Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 Proellex® - Uterine Fibroids | Phase 2 | Completed | Repros Therapeutics Inc. | 65 | 2006-09-07 | 2019-06-18 |
| A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids. Leuprorelin (GF), Leuprorelin (GC) - Uterine Fibroids | Phase 2 | Completed | Takeda | 80 | 2006-06-01 | 2010-06-22 |
| Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids 12.5 mg Proellex, 25 mg Proellex, Placebo - Uterine Fibroids | Phase 2 | Completed | Repros Therapeutics Inc. | 144 | 2006-03-01 | 2014-07-08 |
| A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy Asoprisnil, Placebo - Uterine Fibroids, Leiomyoma | Phase 2 | Completed | Abbott | 33 | 2003-07-01 | 2008-05-29 |
Leiomyoma (15) · Menorrhagia (2) · Fibroma (1) · Myofibroma (1) · Uterine Neoplasms (1)
Neoplasms (15) · Neoplasms by Histologic Type (15) · Neoplasms, Connective and Soft Tissue (15) · Neoplasms, Muscle Tissue (15) · Female Urogenital Diseases (3) · Female Urogenital Diseases and Pregnancy Complications (3) · Genital Diseases (3) · Genital Diseases, Female (3) · Urogenital Diseases (3) · Uterine Diseases (3) · Hemorrhage (2) · Menstruation Disturbances (2) · Neoplasms, Connective Tissue (2) · Pathologic Processes (2) · Pathological Conditions, Signs and Symptoms (2)
telapristone acetate (7) · Estradiol (2) · Mifepristone (2) · Norethindrone Acetate (2) · elagolix (2) · estradiol, norethindrone drug combination (2) · Leuprolide (1) · Progesterone (1) · Sugars (1) · asoprisnil (1) · relugolix (1)
Repros Therapeutics Inc. (7) · Mediterranea Medica S. L. (2) · Takeda (2) · AbbVie (1) · AbbVie (prior sponsor, Abbott) (1) · Abbott (1) · Philips Healthcare (1)
United States (7) · Cuba (2) · Japan (1)
Anna Chan (3) · Andre VanAs, PhD, MD (1) · Carbonell Josep Ll., MD (1) · Charlotte Owens, MD (1) · Josep LL. Carbonell, MD (1) · Ronald D Wiehle, PhD (1)
PMID 17339234, PMID 22626269, PMID 25634727, PMID 27733082, PMID 30303923, PMID 34711224
2005 (1)