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Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men

Male Hypogonadism Clinical Trial

Official title:
Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Clinical Trial Summary

The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.

Clinical Trial Description

This is the long-term extension of Study CLAR-09007, which like Study CLAR-09007, is an open-label study. This study contained an arm to evaluate the oral TU formulation as well as a comparator arm of the market-leading transdermal T-gel formulation. The comparator arm was included in the Phase III study and in this extension study to allow a general evaluation of comparative safety. Subjects randomized to oral TU in the Phase III study were continued on oral TU in the extension, and those who completed this 12-month Phase IV study have been followed for a total of 2 years of oral TU therapy. Likewise, subjects randomized to transdermal T-gel in the Phase III study were continued on T-gel in the extension, and those who completed this 12-month Phase IV study have been followed for a total of 2 years of T gel therapy. This 2-year period of therapy and assessments was to provide a long-term view of the safety of oral TU and the stability of the T replacement. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01699178
Study type Interventional
Source Clarus Therapeutics, Inc.
Contact
Status Completed
Phase Phase 3
Start date August 2012
Completion date April 2014
View Details
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