Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone enanthate auto-injector
Intervention description: Dose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hypogonadism; Testosterone enanthate

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

Eligibility criteria:

        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