Clinical trial: The Role of 5-alpha Reductase in Mediating Testosterone Actions (NCT00493987)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy males between 18 and 50 years of age.

          -  Ambulatory, physically active, but not in competitive sports.

          -  Eugonadal: Normal Serum Testosterone (300-1100 nmol/L).

          -  Normal LH

          -  Normal FSH

          -  Able and willing to comply with the trial protocol.

        Exclusion Criteria:

          -  Known to have a primary or secondary hypogonadism? (e.g. pituitary disease, HIV
             infection, Klinefelter's Syndrome)

          -  BMI > 35

          -  Disability that precludes participation in exercise testing

          -  Alcohol or illicit drug use in the preceding 6 months that would interfere with
             participation and compliance with the protocol

          -  Known disorder that would be exacerbated by androgen treatment e.g. benign prostate
             hyperplasia, prostate Ca, erythrocytosis, sleep apnea)

          -  Any abnormalities in the following laboratory tests PSA > 4 ng/ml AST, ALT or Alkaline
             Phosphatase > 3x ULN? Creatinine level > 2 mg/dL Hematocrit > 51%

          -  Osteoporosis by DEXA BMD T-Score < -2.5

          -  Use of medications that affect muscle or bone metabolism within the previous 3 months
             ?(e.g. glucocorticoids, growth hormone, androgenic steroids, oral androgen precursors
             -i.e. androstenedione or DHEA)

          -  Use of medications that affect androgen metabolism, action or clearance within the
             previous 3 months? (e.g. dilantin, phenobarbital, aldactone, flutamide, finasteride
             and Ketoconazole)

          -  Use of ketoconazole or other potent CYP3A4 inhibitors that may affect clearance of
             dutasteride

          -  Use investigational medication as part of a research study in the last 3 months?
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 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? Contradiction