Safety and Efficacy Trial of Testosterone Undecanoate

Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men

The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.

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