Clinical Trials

Inclusion Criteria:

• 60 healthy men (ages 60 to 80 y);
• BMI 18-30 kg/m2
• Community dwelling; and voluntarily consenting

Exclusion Criteria:

• Recent use of psychotropic or neuroactive drugs (within five biological half-live);
• Obesity (outside weight range above);
• Laboratory test results not deemed physician acceptable, cholesterol >250, triglycerides > 300, BUN >30 or creatinine > 1.5 mg/dL, liver functions tests twice upper limit of normal, electrolyte abnormality, anemia; hemoglobin <12.0 gm/dL
• Drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
• Acute or chronic organ-system disease;
• Endocrinopathy, other than primary thyroidal failure receiving replacement; untreated osteoporosis
• Nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of admission);
• Acute weight change (loss or gain of > 2 kg in 6 weeks);
• Allergy to peanut oil (used in some injectable Te preparations)
• Unwillingness to provide written informed consent.
• PSA > 4.0 ng/mL
• History or suspicion of prostatic disease (elevated PSA, indeterminate nodule or mass, obstructive uropathy.
• History of carcinoma (excluding localized basal cell carcinoma removed or surgically treated with no recurrence.
• History of thrombotic arterial disease (stroke, TIA, MI, angina) or deep vein thrombophlebitis.
• History of CHF, cardiac arrhythmias, congential QT prolongation, and medications used to treat cardiac arrhythmias
• Gynecomastia > 2 cm, untreated
• Untreated gallbladder disease
• History of smoking greater than one ppd.