NCT01699178

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Clarus Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Male Hypogonadism

Interventions

Type	Name	Description
DRUG	Oral testosterone undecanoate	Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID
DRUG	Transdermal testosterone gel (AndroGel)	Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-10-03
• Last updated: 2021-06-28
• Results posted: 2018-10-30

Locations

30 sites across 2 countries: United States, Germany