Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism

Phase 2

Completed

• Conditions: Hypogonadism

• Registration Number: NCT02777242
• Lead Sponsor: Antares Pharma Inc.

Brief Summary

Evaluation of the safety and tolerability of testosterone enanthate (TE) following a single dose via QuickShot® Testosterone (QST) when administered by intended users in a usability study.

Detailed Description

Intended users are patients as well as patient caregivers, such as family members or friends who are able to assist the patient to administer the medication (i.e. lay users). One user group of approximately 15 patients will have their dose administered by a qualified healthcare professional (HCP).

Study Timeline

• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-19
• Study Start: 2016-06
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Disposition First Submitted: 2017-09-26
• Disposition First Submitted QC: 2017-09-26
• Disposition First Posted: 2017-10-02
• Results First Submitted: 2017-12-19
• Results First Submitted QC: 2018-01-25
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-23
• Results First Posted: 2018-02-26
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.	3 weeks	Intended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization.