13 completed, 1 withdrawn. 8 Phase 3, 4 Phase 2, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 7, Withdrawn 1 |
| Phase 2 | 4 | Completed 3, Withdrawn 1 |
| Phase 1 | 3 | Completed 3 |
Follow Androxal: new trials by email Literature Review of Androxal trials Research Report on Androxal
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 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 |
| Androxal in Male Infertility Enclomiphene citrate, Placebo - Infertility | Phase 2 / Phase 3 | Withdrawn | Baylor College of Medicine | 2014-09-22 | 2019-07-11 | |
| 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 |
| 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 |
| Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism enclomiphene citrate, Placebo - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 181 | 2012-11-01 | 2015-05-27 |
| An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism Androxal - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 300 | 2012-11-01 | 2014-04-16 |
| Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism enclomiphene citrate, Placebo - Effect of Treatment on Bone Mineral Density | Phase 3 | Completed | Repros Therapeutics Inc. | 300 | 2012-09-01 | 2014-10-01 |
| Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism Androxal, Placebo - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 151 | 2012-08-01 | 2015-05-27 |
| Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism Androxal - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 499 | 2012-05-01 | 2014-07-24 |
| The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone) Androxal (enclomiphene citrate), Testosterone - Secondary Hypogonadism | Phase 2 | Completed | Repros Therapeutics Inc. | 60 | 2011-06-01 | 2015-09-23 |
| Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism Placebo, topical testosterone, Androxal - Secondary Hypogonadism | Phase 2 | Completed | Repros Therapeutics Inc. | 83 | 2011-01-01 | 2014-07-28 |
| Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus Placebo, Androxal - Type 2 Diabetes Mellitus, Secondary Hypogonadism | Phase 2 | Completed | Repros Therapeutics Inc. | 102 | 2010-10-01 | 2014-07-24 |
| Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Androxal, AndroGel, Placebo - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 194 | 2006-03-01 | 2010-02-11 |
| Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism Androxal - Secondary Hypogonadism | Phase 3 | Completed | Repros Therapeutics Inc. | 104 | 2006-03-01 | 2014-06-27 |
Hypogonadism (11) · Diabetes Mellitus, Type 2 (1) · Infertility (1)
Repros Therapeutics Inc. (13) · Baylor College of Medicine (1)
United States (13)
Joseph S Podolski (4) · Andre van As, MD, PhD (2) · Barbara Cook, MD (1) · Glenn Cunningham, MD (1) · Jolene Berg, MD (1) · Larry I. Lipshultz, MD (1) · Larry Lipshultz, MD (1)