Safety and Efficacy Trial of Testosterone Undecanoate

Inclusion Criteria:

- Serum testosterone of less than or equal to 300 ng/dL (the mean of two samples
collected 1 hour apart in the morning between 6:00 and 10:00 AM)

Exclusion Criteria:

- Significant intercurrent disease of any type, in particular liver, kidney,
uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or
psychiatric illness including depression.

- Recent history of stroke, including transient ischemic attack (TIA) or acute coronary
event

- Untreated, severe obstructive sleep apnea

- Hematocrit <35% or >48%

- Serum transaminases >2 times upper limit of normal, serum bilirubin >2.0 mg/dL, and
serum creatinine >2.0 mg/dL

- BMI > or equal to 38

- Stable doses of lipid-lowering medication for less than three months

- Stable doses of oral medication for diabetes for less than two months

- Abnormal prostate digital rectal examination [palpable nodule(s)], elevated PSA (serum
PSA >3.9 ng/mL), IPSS score > or equal to 19 points, and /or history of prostate
cancer.

- History of breast cancer

- Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary
supplements that may increase serum T, such as androstenedione or DHEA with the
previous 4 weeks

- Know malabsorption syndrome and/or current treatment iwht oral lipase inhibitors

- Known history of abuse of alcohol or any drug substance with the previous 2 years

- Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or
long-acting opioid analgesics

- Receipt of any drug as part of a research study within 30 days of initial dose
administration in this study

- Blood donation within the 12 week period before initial dose administration in this
study