Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone enanthate auto-injector
Intervention description: Dose Adjustment to 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: 150.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypogonadism; Testosterone enanthate

Summary:

      Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using
      an auto-injector
    

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