Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Condition: Male Hypogonadism
MeSH terms: Hypogonadism
Intervention: Oral testosterone undecanoate; topical testosterone gel
Intervention description: 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.; 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.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 325.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: testosterone; male hypogonadism; low testosterone

Summary:

      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.
    

Eligibility criteria:

        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.