Cardiovascular Disease with Low Testosterone (Men 45-80) - Valley Village CA

Summary:

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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 cardiovascular events such as heart attack and stroke in men who do not produce enough testosterone (hypogonadal men) and have symptoms from not enough
testosterone.

AndroGel 1.62% is currently FDA approved for doses ranging from 20.25 mg up to 81 mg. However, the highest possible dose level (101.25 mg) that may be used in this study is investigational
because this dose is not approved for the treatment of low testosterone levels. This is a phase 4, randomized, double-blind, placebo-controlled, multicenter study of topical
(rubbed onto the skin) TRT in men with low testosterone (hypogonadal) who are at increased risk for CV disease. “Phase 4” means that AndroGel 1.62% has already been approved by the
FDA to treat certain causes of low testosterone, and this is a study to answer further questions about the effect of TRT, which could not be answered in earlier studies before the drug was
formally approved.

If you qualify for the study, your participation may last up to approximately 5 years depending on when you begin the study and when the study ends. There are up to 27 required study-related
contacts (approximately 17 office visits and 10 phone calls). For the phone calls, a study staff member will call you and collect the study information over the phone. The study staff will tell
you when to come in to the office for your study visits.

Must be male, between the age of 45-80

AND Must have one of the following medical history:

• Heart Attack 
• 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 [CABG] or Percutaneous Coronary Intervention [PCI])
• Stroke (non-hemorrhagic) 
• TIA  or Mini stroke 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

Qualified Participants May Receive:

• Physical Exam: Some visit will required digital rectal exam
• Electrocardiogram
• Blood Test
• The IRB has also agreed that you may be paid $75.00 for each completed study visit, and $10.00 for each completed phone visit. If applicable you will get $50.00 for each completed
  Screening Visit 3, and $75.00 for each completed Unscheduled visit.