| Proellex (telapristone) / AbbVie |
NCT01800422: Oral CDB-4124 vs. Placebo in Stage I-II Primary Breast Cancer |
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| Unknown status | 2b | 50 | US | telapristone acetate, CDB-4124, Proellex, Progenta, progesterone receptor inhibitor CDB-4124, placebo, PLCB, therapeutic conventional surgery, laboratory biomarker analysis, questionnaire administration | Northwestern University, Breast Cancer Research Foundation, Repros Therapeutics Inc. | Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer | 06/21 | 03/22 | | |
NCT00882258: Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids |
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| Completed | 2 | 144 | US | 12.5 mg Proellex, CDB-4124, Telapristone acetate, 25 mg Proellex, Placebo, Dummy | Repros Therapeutics Inc. | Uterine Fibroids | 03/07 | 03/07 | | |
NCT00958334: Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 |
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| Completed | 2 | 65 | US | Proellex®, CDB-4124, telapristone acetate | Repros Therapeutics Inc. | Uterine Fibroids | 10/08 | 10/08 | | |
NCT00556075: Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis |
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| Terminated | 2 | 67 | US | Proellex 25 mg, Placebo, Proellex 50 mg | Repros Therapeutics Inc. | Endometriosis | 05/09 | 07/09 | | |
NCT00683917: Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids |
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| Terminated | 2 | 10 | US, RoW | Proellex 25 mg, Telapristone acetate, Proellex 50 mg, Lupron Depot, Leuprolide acetate | Repros Therapeutics Inc. | Uterine Fibroids | 08/09 | 08/09 | | |
| Terminated | 2 | 4 | US | 25 mg Proellex, CDB-4124, Proellex | Repros Therapeutics Inc. | Uterine Fibroids | 08/09 | 08/09 | | |
NCT00958412: Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study |
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| Terminated | 2 | 18 | US | Proellex®, CDB-4124 | Repros Therapeutics Inc. | Endometriosis | 08/09 | 08/09 | | |
| Withdrawn | 2 | 0 | US | Proellex, telepristone acetate | Repros Therapeutics Inc. | Endometriosis | 12/14 | 12/14 | | |
NCT01728454: Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis |
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| Completed | 2 | 60 | US | Placebo, Telapristone acetate, Proellex® | Repros Therapeutics Inc. | Endometriosis | 03/17 | 03/17 | | |
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NCT02811159: An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids |
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| Terminated | 2 | 20 | US | Telapristone acetate, Proellex® | Repros Therapeutics Inc. | Uterine Fibroids | 05/17 | 05/17 | | |
NCT02301897: 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 |
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| Completed | 2 | 43 | US | Telapristone Acetate, Proellex®, Placebo, sugar pill | Repros Therapeutics Inc. | Uterine Fibroids | 06/17 | 06/17 | | |
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NCT02314156: Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy |
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| Completed | 2 | 67 | US | Telapristone Acetate, CDB-4124, Proellex, Progenta, Placebo, PLCB, Laboratory Biomarker Analysis, Questionnaire Administration | Northwestern University, National Cancer Institute (NCI) | BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ductal Breast Carcinoma In Situ, Lobular Breast Carcinoma In Situ, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer | 01/18 | 05/21 | | |
NCT01069094: A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata |
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| Completed | 1/2 | 29 | Europe | Progenta, CDB-4124, Telapristone acetate, Lucron Depot, leuprolide acetate for depot suspension, Placebo | Repros Therapeutics Inc. | Uterine Leiomyomata | 01/05 | 01/05 | | |
NCT00787618: Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females |
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| Terminated | 1/2 | 6 | US | 50 mg Proellex, Telapristone acetate, Proellex | Repros Therapeutics Inc. | Renal Impairment | 06/09 | 07/09 | | |
NCT01187043: Determination of the Lowest, Safe and Effective Dose of Proellex |
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| Completed | 1/2 | 52 | US | Proellex, CDB-4124, Telapristone acetate | Repros Therapeutics Inc. | Amenorrhea | 03/12 | 03/12 | | |
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