Clinical Trials Logo

Clinical Trial Summary

This is 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%.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01993225
Study type Interventional
Source Repros Therapeutics Inc.
Contact
Status Completed
Phase Phase 3
Start date January 2014
Completion date August 2014

See also
  Status Clinical Trial Phase
Completed NCT01454011 - The Effect of Testosterone Replacement on the High Density Lipoprotein Cholesterol Subgroups Phase 4
Completed NCT01191320 - Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus Phase 2
Completed NCT01739582 - An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism Phase 3
Completed NCT01739595 - Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism Phase 3
Active, not recruiting NCT02443090 - Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men Phase 2
Completed NCT01534208 - Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism Phase 3
Completed NCT00962637 - Study to Evaluate the Safety and Efficacy of Androxalâ„¢ Treatment in Men With Secondary Hypogonadism Phase 3
Completed NCT00467870 - Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men Phase 3
Completed NCT01067365 - Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism Phase 3
Completed NCT01386606 - The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone) Phase 2
Completed NCT00706719 - To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone Phase 2
Completed NCT00911586 - Pharmacokinetic Study to Determine Time to Steady-state Phase 2
Completed NCT01993212 - 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% Phase 3
Completed NCT01270841 - Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism Phase 2
Completed 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 Phase 1
Completed NCT01923857 - Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function Phase 1
Completed NCT01923870 - Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function Phase 1
Completed NCT01532414 - Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism Phase 3