Clinical trial: Safety and Efficacy Trial of Testosterone Undecanoate (NCT01765179)

Eligibility criteria:
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
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? 1