The primary purpose of this study is to compare the effect of testosterone replacement therapy (TRT) and matching placebo (a gel that is made to look like the TRT but does not have any testosterone drug in it) on major CV events such as heart attack and stroke in men who do not produce enough testosterone (hypogonadal men) and have symptoms from not enough testosterone.
Criteria:1. Presence of at least one sign or symptom that may be related to low testosterone values and is/are consistent with hypogonadism such as the following:
● Decreased sexual desire or libido
● Decreased spontaneous erections (e.g., morning erections)
● Decreased energy or fatigue/feeling tired
● Low mood or depressed mood
● Loss of body (axillary and pubic) hair or reduced shaving
● Hot flashes
2. Have at least one disease
Acute MI > 4 months
Coronary artery disease (at least a 50% lesion in two of the major coronary artery distributions including their branches) as documented by angiogram
Coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention (PCI)
Stroke excluding hemorrhagic
TIA that required treatment
Catheter-based or surgical revascularization of the carotid or middle cerebral arteries
Extracranial carotid artery stenosis > 50%, excluding intracranial vessels
Symptomatic peripheral arterial disease (i.e., lower extremity arterial disease documented by ankle/brachial index < 0.9 with claudication or resting limb ischemia obtained in the prior 12 months)
Peripheral arterial revascularization or amputation due to arterial obstructive disease
Peripheral arterial stenosis > 50%
Abdominal aortic aneurysm not due to connective tissue disorders