Clinical Trial: Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

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

Official Title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Brief Summary: The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.

Detailed Summary:
Sponsor: Clarus Therapeutics, Inc.

Current Primary Outcome: Percentage of oral TU treated patients with average serum testosterone (T)concentrations (Cavg) between 300 and 1000 ng/dL. [ Time Frame: Following 90 days of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Comparison of change from baseline in safety parameters between treatment groups. [ Time Frame: 365 days ]
    • Number of subjects with adverse events during treatment of one year
    • Change from baseline in safety laboratory parameters (i.e., clinical chemistry, hematology, cardiovascular biomarkers, PSA) for up to one year
    • Change from baseline in prostate volume for up to one year
  • Percentage of treated patients with maximum serum T concentrations (Cmax) values that are (a) less than 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: 90 days ]


Original Secondary Outcome: Same as current

Information By: Clarus Therapeutics, Inc.

Dates:
Date Received: July 25, 2011
Date Started: July 2011
Date Completion:
Last Updated: December 17, 2013
Last Verified: December 2013