Clinical Trial: Safety and Efficacy Trial of Testosterone Undecanoate

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men

Brief Summary: The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.

Detailed Summary:
Sponsor: Clarus Therapeutics, Inc.

Current Primary Outcome: Percentage of treated patients with an average serum testosterone (T) concentration (Cavg) between 300 and 1000 ng/dL [ Time Frame: Following 114 days of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Percentage of treated patients with maximum serum T concentrations (Cmax) values that are a)less that 1500 ng/dL; b) between 1500 and 1800 ng/dL; c) between 1800 and 2500 ng/dL; and d) greater than 2500 ng/dL. [ Time Frame: Following 114 days of treatment ]

Original Secondary Outcome: Same as current

Information By: Clarus Therapeutics, Inc.

Dates:
Date Received: January 8, 2013
Date Started: January 2013
Date Completion:
Last Updated: December 17, 2013
Last Verified: December 2013