Safety and Efficacy Trial of Testosterone Undecanoate

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