Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism

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.

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