24 completed, 1 withdrawn. 10 Phase 3, 9 Phase 1, 7 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Completed 9, Withdrawn 1 |
| Phase 1 | 9 | Completed 9 |
| Phase 2 | 7 | Completed 6, Withdrawn 1 |
Follow Enclomiphene: new trials by email Literature Review of Enclomiphene trials Research Report on Enclomiphene
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 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 |
| 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| Androxal in Male Infertility Enclomiphene citrate, Placebo - Infertility | Phase 2 / Phase 3 | Withdrawn | Baylor College of Medicine | 2014-09-22 | 2019-07-11 | |
| 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 |
| 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 |
| 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 |
| 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 |
| A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203 Androxal (enclomiphene citrate), Testim (topical testosterone) - Hypogonadism, Low Testosterone | Phase 2 | Completed | Repros Therapeutics Inc. | 48 | 2011-07-01 | 2013-05-17 |
| 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 |
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Hypogonadism (17) · Diabetes Mellitus, Type 2 (1) · Infertility (1) · Obesity (1)
Repros Therapeutics Inc. (24) · Baylor College of Medicine (1)
United States (22)
Joseph S Podolski (4) · Andre van As, MD, PhD (2) · Anna Chan (2) · Barbara Cook, MD (1) · Glenn Cunningham, MD (1) · Jolene Berg, MD (1) · Larry I. Lipshultz, MD (1) · Larry Lipshultz, MD (1) · Ronald Wiehle, PhD (1)