Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism

Study Overview
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Brief Summary
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Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.

Detailed Description
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Safety assessments, including laboratory assessments, adverse events and injection site assessments, will be conducted for all patients at scheduled intervals during the Treatment Titration Period.

Official Title
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A 6-Month Safety Study of QuickShot™ Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

Conditions
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Hypogonadism

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men ≥18 and ≤75 years of age with a documented history 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 prostate-specific antigen (PSA) for age. Abnormal digital rectal examination (DRE) Unstable psychiatric illnesses Obstructive uropathy of prostatic origin Poorly controlled diabetes Congestive heart failure Within 6 months of screening, myocardial infarction (MI), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease. History or current treatment of thromboembolic disease. Use of adrenocorticotropic hormone (ACTH) 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, gonadotropin-releasing hormone (GnRH) or growth hormone within 12 months of screening. Use of other androgens (DHEA), anabolic steroids, other sex hormones) or other substances/supplements know to affect the pharmacokinetics (PK) 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
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 50 mg or 75 mg or 100 mg based upon Testosterone levels<br>* Other names: QuickShot® Testosterone (QST);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism | Number of participants experiencing adverse events that started on or after the first dose of QST, or existed prior to the first dose and woresened in severity or relatedness to QST after dosing, were evaluated in this population. Although a patient may have had 2 or more TEAEs or SAEs, the patient was counted only once within a SOC category. The same patient may have contributed to 2 or more preferred term categories. (Four patients had a total of 9 SAEs during the study) | 26 weeks | 

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