Clinical trial: TOM: Testosterone in Older Men With Sarcopenia (NCT00240981)

Eligibility criteria:
Inclusion Criteria:

          -  Community dwelling, ages 65 and older

          -  Self-reported difficulty in climbing 10 steps without resting, or difficulty in
             walking 2 or 3 blocks outside on level ground

          -  A score of 4 to 9 on the Short Physical Performance Battery (mild to moderate physical
             impairment)

          -  Total serum testosterone level (TT) < 350 ng/dL and > 100 ng/dL

          -  Without dementia (Mini-Mental State Examination [MMSE] score > 24)

        Exclusion Criteria:

          -  Use of testosterone, anabolic steroids, dehydroepiandrosterone (DHEA), androstenedione
             or recombinant growth hormone (rGH) in the past year

          -  Alcohol or drug abuse

          -  Use of anti-convulsants or glucocorticoids (equivalent to prednisone > 20 mg/day)

          -  Prostate cancer, breast cancer or other cancers with life expectancy < 5 years

          -  Limiting neuromuscular, joint or bone disease, or history of stroke with residual
             neurological problems

          -  Any neurological condition that would impact cognitive functioning including:

               -  epilepsy

               -  multiple sclerosis

               -  HIV

               -  Parkinson's disease

               -  stroke

               -  other focal lesion

          -  Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I
             psychiatric disorder in past year or use of psychotropic medications in 6 months

          -  Abnormal prostate examination; PSA > 4 ng/mL; or BPH symptom score > 21

          -  Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial
             infarction within 3 months of entry

          -  Abnormal laboratory values (at discretion of principal investigator)

          -  Untreated thyroid disease; systolic blood pressure > 160 or diastolic > 100 mm Hg

          -  Body mass index > 40 kg/m2

          -  Untreated severe obstructive sleep apnea
Male
No healthy subjects accepted to join the trial.
Subject must be at least 65 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