Clinical Trial: Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) 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: Lipocine Inc.
Current Primary Outcome: Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL. [ Time Frame: Following 13 weeks of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of LPCN 1021-treated subjects with maximum serum T concentrations (Cmax) values that are (a) less than 1500 ng/dL; (b) between 1800 and 2500 ng/dL, and (c) greater than 2500 ng/dL [ Time Frame: Following 13 weeks of treatment ]
- Change from baseline in patient reported outcomes for LPCN 1021 (i.e., International Prostate Symptom Score [I-PSS], Psychosexual Daily Questionnaire [PDQ], Short Form-36 Questionnaire [SF-36]) [ Time Frame: 52 weeks ]
- Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA) [ Time Frame: 52 weeks ]
- Number of subjects with adverse events during 52 weeks of treatment [ Time Frame: 52 weeks ]
Original Secondary Outcome: Same as current
Information By: Lipocine Inc.
Dates:
Date Received: February 20, 2014
Date Started: February 2014
Date Completion:
Last Updated: July 10, 2015
Last Verified: July 2015
