Clinical trial: Testosterone and Pain Sensitivity (NCT01689896)

Eligibility criteria:
Inclusion Criteria:

          -  Men

          -  18 Years of Age and Older

          -  Serum total testosterone level <300 ng/dl or free testosterone < 50 pg/ml

          -  Consumption of at least 10 mg of hydrocodone (or analgesic equivalent of another
             opioid) for at least 4 weeks

          -  Absence of hospitalization in past 2 months

          -  No acute illness in past 2 months

          -  No prior history of any form of hypogonadism

          -  No current anabolic therapy (growth hormone, DHEA, etc)

          -  No current use or consumption in past 2 months of glucocorticoids and melatonin

          -  Normal digital rectal examination

          -  Normal PSA level

        Exclusion Criteria:

          -  Liver enzymes >3 times upper limit of normal

          -  Serum creatinine > 2 times upper limit of normal

          -  Neurological disease

          -  Active psychiatric illness

          -  Any addictive and/or illicit drug use

          -  Alcoholism (>10 drinks/week)

          -  Patients currently receiving glucocorticoids, melatonin or anabolic agents

          -  Hospitalization in past 2 months

          -  Acute illness in past 2 months

          -  Consumption of < 20 mg of hydrocodone (or analgesic equivalent of another opioid)

          -  Severe BPH

          -  PSA >4.0 ng/ml

          -  Prostate cancer

          -  Breast cancer

          -  Any cancer or cancer related pain

          -  History of alcohol abuse

          -  Known peripheral neuropathy (any etiology) or peripheral vascular disease (including
             Raynaud's disease), which may interfere with pain testing

          -  Concurrent warfarin treatment
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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? Contradiction