Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men

Inclusion Criteria:

- Male with primary or secondary hypogonadism at least 18 years of age and for study
part C2 weighs ≥143.3 lb (≥65 kg)

- Morning screening serum testosterone concentration <300 ng/dL

Exclusion Criteria:

- American Urological Association (AUA) Symptom Score ≥15 or significant prostatic
symptoms

- History of carcinoma, tumors or induration of the prostate or the male mammary gland
including suspicion thereof

- Screening serum prostate-specific antigen (PSA) level >4 ng/mL or hyperplasia of the
prostate (size >75 cm3 as measured by transrectal ultrasonography)

- Past or present liver tumors or acute or chronic hepatic disease with impairment of
liver function; liver function tests (alanine aminotransferase [ALT], aspartate
aminotransferase [AST]) exceeding 1.5 times upper limit of normal

- History of deep vein thrombosis in the past 5 years or any history of cerebrovascular
accident

- Severe acne

- Hypertension (systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm
Hg) or coronary heart disease not stabilized by therapy as assessed by the
investigator

- Insulin-dependent diabetes mellitus or uncontrolled non-insulin-dependent diabetes
mellitus; patients with diabetes are excluded if screening glycated hemoglobin (HbA1C)
level is >9%

- Use of any sex hormones within 28 days (for injectable testosterone preparations) or 7
days (for oral, gel, patch, etc, testosterone preparations) prior to screening visit
and throughout the study (exclusive of administered study drug)

- Use of steroidal anabolic drugs or supplements (eg, dehydroepiandrosterone [DHEA]) by
any application method within the 28 days prior to first administration of study drug
and throughout the study (exclusive of administrated study drug)

- Medication with substances which might interfere with testosterone metabolism within
28 days before the first administration of study drug

- History of sleep apnea Insulin-dependent diabetes mellitus

- Use of steroidal anabolic drugs or supplements by any application method within the
28-days prior to the first administration of the study drug and throughout the study
(exclusive of the administered study drug)