| Androxal (enclomifene) / AbbVie |
NCT01959685: A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal |
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| Completed | 1 | 9 | US | Androxal, Enclomiphene citrate, Placebo, Sugar pill | Repros Therapeutics Inc. | Pharmacokinetics, Tolerability | 11/13 | 11/13 | | |
| Completed | 1 | 16 | US | 12.5 mg Androxal Formulation A, enclomiphene citrate, 12.5 mg Androxal Formulation B, 25 mg Androxal Formulation A, 25 mg Androxal Formulation B | Repros Therapeutics Inc. | Bioequivalence | 12/13 | 12/13 | | |
NCT01923870: Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function |
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| Completed | 1 | 19 | US | Androxal 25 mg, enclomiphene citrate | Repros Therapeutics Inc. | Secondary Hypogonadism | 01/14 | 01/14 | | |
NCT02117830: A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects |
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| Completed | 1 | 54 | US | Androxal 25 mg capsules, Androxal 250 Capsules, Placebo Capsules, Moxifloxacin 400 mg | Repros Therapeutics Inc. | Healthy | 05/14 | | | |
NCT01991327: Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males |
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| Completed | 1 | 30 | US | Androxal, enclomiphene citrate, Placebo | Repros Therapeutics Inc. | Drug-drug Interaction | 07/14 | 07/14 | | |
NCT02146391: Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal |
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| Completed | 1 | 12 | US | Androxal 25 mg Capsules | Repros Therapeutics Inc. | Normal Volunteers | 07/14 | 07/14 | | |
NCT01923857: Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function |
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| Completed | 1 | 26 | US | Androxal 25 mg, enclomiphene citrate | Repros Therapeutics Inc. | Secondary Hypogonadism | 08/14 | 08/14 | | |
NCT02169804: An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal |
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| Completed | 1 | 24 | US | Androxal 25 mg | Repros Therapeutics Inc. | Pharmacokinetics | 08/14 | 08/14 | | |
NCT02274181: 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 |
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| Completed | 1 | 6 | US | Androxal | Repros Therapeutics Inc., Celerion | Secondary Hypogonadism | 01/15 | 01/15 | | |