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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Combination Product: Testosterone enanthate auto-injector


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosterone enanthate auto-injector<br>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. | Combination Product: Testosterone enanthate auto-injector<br>* Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels<br>* Other names: QuickShot® Testosterone (QST);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL) | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | Incidence of adverse events throughout the study Incidence and severity of injection site reactions throughout the study | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypogonadism, Testosterone enanthate