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

Phase 3

Completed

• Conditions: Hypogonadism
• Interventions: Combination Product: Testosterone enanthate auto-injector

• Registration Number: NCT02159469
• Lead Sponsor: Antares Pharma Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-10
• Study Start: 2014-07
• Primary Completion: 2015-02
• Study Completion: 2015-11
• Disposition First Submitted: 2017-08-01
• Disposition First Submitted QC: 2017-08-01
• Disposition First Posted: 2017-08-08
• Results First Submitted: 2017-12-12
• Results First Submitted QC: 2017-12-12
• Status Verified: 2018-01
• Results First Posted: 2018-01-09
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

• Adult males aged ≥ 18 year of age with a documented diagnosis of hypogonadism
• Total testosterone levels < 300 ng/dL at two qualification visits
• Patients in good general health

Exclusion Criteria

• Allergy to sesame or testosterone products
• BMI ≥ 40 kg/m2
• Hematocrit ≥ 52%
• History or current evidence of breast or prostate cancer
• Elevated PSA (Prostate-Specific Antigen) for age.
• Abnormal DRE (digital rectal examination)
• Obstructive uropathy of prostatic origin
• Poorly controlled diabetes
• Congestive heart failure
• Within 6 months of screening, MI (myocardial ischemia), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, ceratoid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease.
• History or current treatment of thromboembolic disease.
• Use of ACTH (adrenocorticotropic hormone) or oral/depot corticosteroids within 6 weeks of screening.
• History of severe, untreated sleep apnea
• Subjects with any clinically significant medical condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study
• Positive serology for HIV, hepatitis B or hepatitis C
• Current evidence of drug or alcohol abuse.
• Skin conditions in injection site that could confound injection site assessments.
• Administration of other investigational compounds within one month of screening or 5 half-lives of the investigational compound, whichever is longer).
• Use of estrogen, GnRH (gonadotropin-releasing hormone) or growth hormone within 12 months of screening.
• Use of other androgens (DHEA(Dehydroepiandrosterone), anabolic steroids, other sex hormones) or other substances/supplements know to affect the PK (pharmacokinetics) of testosterone enanthate
• Considered or scheduled surgical or dental procedures associated with blood loss ≥500 mL during study.
• Donation of plasma or blood within 56 days of screening or history of donation of > 50 mL of blood or plasma within 3 months of screening.
• Donation of plasma or blood during study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Testosterone enanthate auto-injector	Testosterone enanthate auto-injector	Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)	12 weeks	The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	52 weeks	* Incidence of adverse events throughout the study; * Incidence and severity of injection site reactions throughout the study