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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 the 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 NCT01993212
Study type Interventional
Source Repros Therapeutics Inc.
Contact
Status Completed
Phase Phase 3
Start date January 2014
Completion date September 2014

See also
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Completed NCT01739595 - Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism Phase 3
Completed NCT01739582 - An Extension Study of Enclomiphene Citrate in the Treatment of 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
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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 NCT01993225 - 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