Clinical trial: Testosterone Replacement in Older Men and Atherosclerosis Progression (NCT00287586)

Eligibility criteria:
Inclusion Criteria:

          -  Age 60 years or greater

          -  Hypogonadism, Testosterone 100-400 ng/dl or Free Testosterone < 50 pg/ml

          -  Generally good health

          -  At least 8 years of primary school education

          -  Able to pass screening test for dementia

          -  Able to give informed consent

        Exclusion Criteria:

          -  Testosterone level < 100 ng/dl (these individuals will be referred for evaluation of
             severe hypogonadism)

          -  Use of testosterone or other androgens [dehydroepiandrosterone (DHEA),
             Androstenedione] in last year

          -  Use of growth hormone in the last year

          -  Current alcohol of drug dependence [Alcohol Use Disorders Identification Test (AUDIT)
             Score > 8]

          -  Diseases known to affect gonadal function

          -  Medications known to affect gonadal function eg. anticonvulsants, glucocorticoids such
             as prednisone

          -  Prostate cancer, breast cancer

          -  Any cancer that may limit life expectancy to less than 5 years

          -  Limiting neuromuscular, joint or bone disease

          -  History of stroke with residual neurologic deficit

          -  Neurologic condition that would impair cognitive function including:

        epilepsy, multiple sclerosis, human immunodeficiency virus (HIV), Parkinson's disease,
        stroke

          -  Psychiatric disorder in the last year meeting Diagnostic and Statistical Manual of
             Mental Disorders, 4th edition (DSMIV) Axis 1 criteria

          -  Use of psychotropic medicine for at least 6 months

          -  Dementia as assessed by (Telephone Interview for Cognitive Status modified score less
             than 31)

          -  Severe symptoms of benign prostatic hyperplasia (BPH) (American Urological Association
             symptom index score greater than 21)

          -  Prostate nodule or induration of digital rectal exam (DRE)

          -  Prostate specific antigen (PSA) greater than 4 unless participant has had a negative
             transrectal biopsy within last 3 months

          -  Limiting heart disease in including New York (NY) Class III or IV - congestive heart
             failure, unstable angina, or myocardial infarction (MI) in last 3 months

          -  Liver function tests [aspartate aminotransferase (AST) and alanine
             aminotransferase(ALT)] greater than 3 times the upper limit of the reference range

          -  Serum creatinine (Cr) greater than 2.5 mg/dl

          -  Hematocrit greater than 48%

          -  Hemoglobin (Hb)A1c greater than 9.0%

          -  Untreated thyroid disease

          -  Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic
             blood pressure greater than 100 mmHg)

          -  Body mass index (BMI greater than 35 kg/m2)

          -  Untreated severe obstructive sleep apnea

          -  Development of electrocardiogram (EKG) changes consistent with myocardial ischemia or
             changes in blood pressure during cardiopulmonary exercise testing will be excluded
             from testing of muscle strength and physical function.
Male
Accepts Healthy Volunteers
Subject must be at least 60 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? 0