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Clinical trial

Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism (SOAR)

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Last updated:1st Feb 2015

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.

Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men
Enrollment: 315
Study Start Date: February 2014
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

- Experimental:
Oral testosterone undecanoate, LPCN 1021
- Topical testosterone gel 1.62 %

Category Value
Study start date 2015-02-01

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