drugset
drugset / Trial / NCT02081300

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

NCT02081300 ↗

Phase 3 Completed 315 enrolled Lipocine Inc. PPD Development, LP · collabSyneos Health · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2014-02
Primary completion
2015-05
Completion
2015-05

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Testosterone Small molecule 20.25 mg Topical
Subject Testosterone Small molecule 40.5 mg Topical
Subject Testosterone Small molecule 81 mg Topical
Subject Testosterone Undecanoate Small molecule 150 mg Oral
Subject Testosterone Undecanoate Small molecule 225 mg Oral
Subject Testosterone Undecanoate Small molecule 300 mg Oral

Indications

hypogonadism, male