Clinical trial: Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men (NCT02697188)

Eligibility criteria:
Inclusion Criteria:

        Male, ages 18 to 65 Serum total testosterone less than or equal to 250 ng/dL Naive to
        androgen replacement therapy Subject must be on stable doses of thyroid or adrenal
        replacement hormones for at least 14 days prior to enrollment

        Exclusion Criteria:

        Significant intercurrent disease of any type, in particular, liver, kidney or heart
        disease, uncontrolled diabetes mellitus or psychiatric illness. Patients with treated
        hyperlipidemia will not be excluded provided they have been stable on their lipid-lowering
        mediation for at least three months. For non-insulin dependent diabetic subjects, HbA1c>9%.

        Abnormal prostate digital rectal examination, elevated PSA (serum PSA >4ng/mL), AUA Sympton
        Score greater than or equal to 15 points, and a history or prostate cancer.

        Serum transaminases >2X upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL.

        History of severe or multiple allergies, severe adverse drug reaction or leucopenia. Known
        hypersensitivity to lidocaine or all surgical dressings.

        History of abnormal bleeding tendencies. Oral, topical, or buccal T therapy within the
        previous week, or intramuscular T injection within the previous 4 week.

        Use of dietary supplements that may increase serum T, such as androstenedione or DHEA,
        within the previous 4 weeks.

        Know malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile
        acid-binding resins, colestipol, fibric acid derivatives, gemfibrozil, and probucol.

        Smokers who are unable to refrain from smoking during confinement periods. History of, or
        current evidence of, abuse of alcohol or any drug substance. Poor compliers or those
        unlikely to attend. Receipt of any drug as part of a research study within 30 days of
        inital dose administration in this study.

        Blood donation (usually 550 mL) within the 12-week period before the initial study dose.

        Hematocrit less than 35%. Known clinical polycythemia or hematocrit greater than 50%.
        Current use of paroxetine and clomipramine, antiandrogens, estrogens, p450 enzyme inducers,
        or barbiturates.

        History of sleep apnea.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 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