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Clinical Trial Summary

Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.


Clinical Trial Description

The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01067365
Study type Interventional
Source Repros Therapeutics Inc.
Contact
Status Completed
Phase Phase 3
Start date March 2006
Completion date May 2007

See also
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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
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Completed NCT01532414 - Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism Phase 3