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Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men

Hypogonadism Clinical Trial

Official title:
An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men

Clinical Trial Summary

The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.

Clinical Trial Description

Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01104246
Study type Interventional
Source Watson Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date April 2010
Completion date September 2010
View Details
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