Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

• Comparison of change from baseline in safety parameters between treatment groups. [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
  • Number of subjects with adverse events during treatment of one year
  • Change from baseline in safety laboratory parameters (i.e., clinical chemistry, hematology, cardiovascular biomarkers, PSA) for up to one year
  • Change from baseline in prostate volume for up to one year
• Percentage of treated patients with maximum serum T concentrations (Cmax) values that are (a) less than 1500 ng;dL, (b) between 1500 and 1800 ng/dl, (c) between 1800 and 2500 ng/dL, and (d) greater than 2500 ng/dL. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.

• Drug: oral testosterone undecanoate
  Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
• Drug: topical testosterone gel 1%
  Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.

• Experimental: Oral testosterone undecanoate (TU)
  Intervention: Drug: oral testosterone undecanoate
• Active Comparator: topical testosterone gel
  Intervention: Drug: topical testosterone gel 1%

Inclusion Criteria:

• Serum testosterone of less than or equal to 300 ng/dL on two occasions within one week (may wash out from previous oral, topical or buccal testosterone therapy)

Exclusion Criteria:

• Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness
• Recent history of stroke, not including transient ischemic attack
• Untreated, sever 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 mgk/dL
• BMI > or equal to 36
• Stable doses of lipid-lowering medication for less than 3 months
• Stable doses of oral medication for diabetes for less than 2 months
• Abnormal prostate DRE [palpable nodule(s)], elevated PSA (>4 ng/mL), IPSS score > or equal to 19 points.
• History of breast cancer
• Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum testosterone within previous 4 weeks
• Known malabsorption syndrome and/or current treatment with oral lipase inhibitors
• History of abuse of alcohol or any drug substance within 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 the initial study dose.

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• Los Angeles Biomedical Research Institute