43 completed, 13 terminated, 2 withdrawn, 1 unknown. 24 Phase 2, 22 Phase 1, 16 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 24 | Completed 16, Terminated 6, Unknown 1, Withdrawn 1 |
| Phase 1 | 22 | Completed 20, Terminated 2 |
| Phase 3 | 16 | Completed 9, Terminated 6, Withdrawn 1 |
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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 |
| A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene Placebo, Enclomiphene - Acquired Hypogonadotropic Hypogonadism, Obesity | Phase 2 | Completed | Repros Therapeutics Inc. | 50 | 2016-01-11 | 2019-06-27 |
| 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 |
| An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration Androxal - Secondary Hypogonadism | Phase 1 | Completed | Repros Therapeutics Inc. | 6 | 2014-12-01 | 2015-03-12 |
| An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal Androxal 25 mg - Pharmacokinetics | Phase 1 | Completed | Repros Therapeutics Inc. | 24 | 2014-08-01 | 2014-10-01 |
| Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal Androxal 25 mg Capsules - Normal Volunteers | Phase 1 | Completed | Repros Therapeutics Inc. | 12 | 2014-06-01 | 2014-08-11 |
| Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males Androxal, Placebo - Drug-drug Interaction | Phase 1 | Completed | Repros Therapeutics Inc. | 30 | 2014-05-01 | 2014-08-11 |
| 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 |
| A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects Androxal 25 mg capsules, Androxal 250 Capsules, Placebo Capsules - Healthy | Phase 1 | Completed | Repros Therapeutics Inc. | 54 | 2014-04-01 | 2014-06-16 |
| A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% Androxal 12.5 mg/25 mg, Placebo Capsules, AndroGel 1.62% - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 120 | 2014-01-01 | 2014-10-01 |
| A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% Androxal 12.5 mg or 25 mg, AndroGel 1.62%, Placebo Capsules - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 120 | 2014-01-01 | 2014-10-01 |
| Comparison of Two Formulations of Androxal 12.5 mg Androxal Formulation A, 12.5 mg Androxal Formulation B, 25 mg Androxal Formulation A - Bioequivalence | Phase 1 | Completed | Repros Therapeutics Inc. | 16 | 2013-12-31 | 2019-05-06 |
| Open-Label Extension Study to ZPE-202 Proellex - Endometriosis | Phase 2 | Withdrawn | Repros Therapeutics Inc. | 2013-12-01 | 2014-02-07 | |
| Comparison of Two Formulations of Proellex for Vaginal Administration Proellex Formulation A, Proellex Formulation B - Comparison of 2 Different Formulations of 12 mg Proellex Vaginal Capsules | Phase 1 | Completed | Repros Therapeutics Inc. | 8 | 2013-10-01 | 2014-01-24 |
| A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal Androxal, Placebo - Pharmacokinetics, Tolerability | Phase 1 | Completed | Repros Therapeutics Inc. | 9 | 2013-10-01 | 2014-08-11 |
| Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function Androxal 25 mg - Secondary Hypogonadism | Phase 1 | Completed | Repros Therapeutics Inc. | 19 | 2013-08-01 | 2014-01-24 |
| Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function Androxal 25 mg - Secondary Hypogonadism | Phase 1 | Completed | Repros Therapeutics Inc. | 26 | 2013-08-01 | 2014-08-11 |
| 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 |
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Leiomyoma (18) · Hypogonadism (16) · Endometriosis (4) · Amenorrhea (2) · Anemia (2) · Pelvic Pain (2) · Breast Neoplasms (1) · Diabetes Mellitus, Type 2 (1) · Fibroma (1) · Liver Diseases (1) · Myofibroma (1) · Obesity (1) · Renal Insufficiency (1)
telapristone acetate (34) · Enclomiphene (24) · Testosterone (5) · Sugars (4) · Leuprolide (2) · Caffeine (1) · Dextromethorphan (1) · Midazolam (1) · Moxifloxacin (1) · Omeprazole (1) · Tolbutamide (1)
United States (53) · Mexico (2) · Brazil (1) · Poland (1)
Andre van As, MD, PhD (9) · Anna Chan (9) · Joseph S Podolski (4) · Ronald Wiehle, PhD (3) · Andre VanAs, PhD, MD (1) · Andre van As, M.D., Ph.D (1) · Andre van As, PhD, MD (1) · Anne Chan (1) · Barbara Cook, MD (1) · Glenn Cunningham, MD (1) · Jolene Berg, MD (1) · Larry Lipshultz, MD (1) · Laura M Sterling, MD (1)