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