Clinical trial: Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency (NCT00161304)

Eligibility criteria:
Inclusion Criteria:Inclusion Criteria

          1. Male aged 50-80 years of age, ambulatory, and in good general physical and mental
             health.

          2. Clinical diagnosis of hypogonadism defined as a serum testosterone level less than 300
             ng/dl on a morning serum sample during the screening period.

          3. Answering yes to question 1 or 7 or to any three questions total on the Morley index
             at baseline.

          4. PSA <10 ng/ml

          5. Subject is able to give informed consent.

        Exclusion Criteria

          1. Failure to meet the criteria for inclusion

          2. History of allergy to testosterone or any components of the delivery system.

          3. Significant abnormalities on pre-study clinical examination or laboratory
             measurements.

          4. Treatment with any investigational drug during the previous month.

          5. Drug or alcohol abuse or dependence.

          6. Concurrent use of testosterone and or any hormonal therapy, including health food
             supplements and herbal products, that could alter serum testosterone levels or affect
             the prostate (e.g. gonadotropic releasing hormone agonists, testosterone antagonists,
             anabolic steroids, DHEA, androstenedione, PC-SPES, chrysin and tribulus terrestris,).
             Use of alpha-reductase inhibitors or prostate phytotherapy within the past 3 months.

          7. Use of antidepressant medications, oral glucocorticoids, or opioids.

          8. PSA > 10 ng/ml and/or prostate biopsy positive for cancer at screening. Any patient in
             whom there is a suspicion of prostate cancer must undergo appropriate testing to rule
             out cancer prior to entry into the study.

          9. IPSS score  20.

         10. History of malignancy of any type (except basal cell carcinoma).

         11. Patients with uncontrolled diabetes.

         12. Patients with known or suspected bleeding disorder. Concurrent use of Coumadin and
             other anticoagulants at the time of biopsy or if discontinuation of such therapy prior
             to biopsy poses a risk to the patient.

         13. Inability of the patient to provide written informed consent for any reason, including
             legal incompetence, language or comprehension difficulty, and psychological,
             psychiatric or emotional factors.

         14. Inability of the patient to have transrectal ultrasonography with biopsy (for any
             reason).

         15. A history of any illness or condition that, in the opinion of the investigator, might
             confound the results of the study or pose additional risk to the patient.
Male
Accepts Healthy Volunteers
Subject must be at least 50 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