Clinical trial: Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men (NCT01403116)

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.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Entailment