NCT02159469

Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism

A Multiple-dose, 52-week Study to Evaluate the Efficacy and Safety of Testosterone Enanthate Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Antares Pharma Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector

Detailed description

This study will evaluate, if testosterone enanthate administered subcutaneously once each week by an auto-injector to men with low testosterone, can raise their levels into the normal range. The study will investigate the ability to adjust testosterone enanthate dose levels using single point blood concentrations. Safety and tolerability of testosterone administration will be evaluated along with the patient's ability to use the auto-injector and follow the instructions for auto-injector use.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Testosterone enanthate auto-injector	Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-02-01
• Completion: 2015-11-01
• First posted: 2014-06-10
• Last updated: 2018-02-07
• Results posted: 2018-01-09

Locations

28 sites across 1 country: United States