19 completed, 13 terminated, 2 withdrawn, 1 unknown. 19 Phase 2, 12 Phase 1, 7 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 19 | Completed 11, Terminated 6, Unknown 1, Withdrawn 1 |
| Phase 1 | 12 | Completed 10, Terminated 2 |
| Phase 3 | 7 | Terminated 6, Withdrawn 1 |
Follow telapristone acetate: new trials by email Literature Review of telapristone acetate trials Research Report on telapristone acetate
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 |
|---|---|---|---|---|---|---|
| An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids Telapristone acetate - Uterine Fibroids | Phase 2 | Terminated | Repros Therapeutics Inc. | 20 | 2016-07-26 | 2019-06-27 |
| Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy Telapristone Acetate, Placebo, Laboratory Biomarker Analysis - BRCA1 Mutation Carrier, BRCA2 Mutation Carrier | Phase 2 | Completed | Northwestern University | 67 | 2015-10-01 | 2023-02-22 |
| 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 |
| Comparison of Two Formulations of Proellex for Oral Administration Telapristone Acetate, Proellex 12 mg Formulation A, Telapristone Acetate, Proellex 12 mg Formulation B - Healthy | Phase 1 | Completed | Repros Therapeutics Inc. | 12 | 2014-05-01 | 2014-09-03 |
| Open-Label Extension Study to ZPE-202 Proellex - Endometriosis | Phase 2 | Withdrawn | Repros Therapeutics Inc. | 2013-12-01 | 2014-02-07 | |
| Oral CDB-4124 vs. Placebo in Stage I-II Primary Breast Cancer telapristone acetate, placebo, therapeutic conventional surgery - Stage IA Breast Cancer, Stage IB Breast Cancer | Phase 2 | Unknown | Northwestern University | 50 | 2013-06-01 | 2020-01-18 |
| Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis Placebo, Telapristone acetate - Endometriosis | Phase 2 | Completed | Repros Therapeutics Inc. | 60 | 2013-05-02 | 2019-07-23 |
| 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 |
| Determination of the Lowest, Safe and Effective Dose of Proellex Proellex - Amenorrhea | Phase 1 / Phase 2 | Completed | Repros Therapeutics Inc. | 52 | 2010-08-01 | 2014-07-28 |
| Investigate Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose in Healthy Females Proellex - ABSORPTION, METABOLISM | Phase 1 | Completed | Repros Therapeutics Inc. | 6 | 2009-04-01 | 2014-07-08 |
| Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids Proellex - Uterine Fibroids | Phase 3 | Terminated | Repros Therapeutics Inc. | 27 | 2009-04-01 | 2014-08-21 |
| Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study Proellex® - Endometriosis | Phase 2 | Terminated | Repros Therapeutics Inc. | 18 | 2009-02-28 | 2019-02-12 |
| Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids Proellex, placebo - Uterine Fibroids | Phase 3 | Terminated | Repros Therapeutics Inc. | 71 | 2009-02-01 | 2014-08-21 |
| Study to Evaluate Menses Induction in Women Administered Proellex Placebo, Proellex - Amenorrhea | Phase 1 | Terminated | Repros Therapeutics Inc. | 11 | 2009-02-01 | 2014-08-25 |
| Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults Proellex - Impaired Liver Function | Phase 1 | Completed | Repros Therapeutics Inc. | 16 | 2008-10-01 | 2014-08-28 |
| Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females 50 mg Proellex - Renal Impairment | Phase 1 / Phase 2 | Terminated | Repros Therapeutics Inc. | 6 | 2008-10-01 | 2014-08-25 |
| Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids Proellex 25 mg, Proellex 50 mg, Placebo - Uterine Fibroids, Anemia | Phase 3 | Terminated | Repros Therapeutics Inc. | 8 | 2008-10-01 | 2014-08-21 |
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Leiomyoma (18) · Endometriosis (4) · Amenorrhea (2) · Anemia (2) · Breast Neoplasms (2) · Pelvic Pain (2) · Breast Carcinoma In Situ (1) · Carcinoma, Intraductal, Noninfiltrating (1) · Fibroma (1) · Liver Diseases (1) · Myofibroma (1) · Renal Insufficiency (1)
Repros Therapeutics Inc. (33) · Northwestern University (2)
United States (32) · Mexico (2) · Brazil (1) · Poland (1)
Andre van As, MD, PhD (7) · Anna Chan (7) · Ronald Wiehle, PhD (2) · Andre VanAs, PhD, MD (1) · Andre van As, M.D., Ph.D (1) · Andre van As, PhD, MD (1) · Anne Chan (1) · Laura M Sterling, MD (1) · Ronald D Wiehle, PhD (1) · Seema Khan (1) · Seema Khan, MD (1)