A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men

Open to males ages 45-80

• Men between 45 and 80 years age
• Participants with low serum testosterone concentrations (< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease.

• Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
• Participants with prostate specific antigen (PSA) > 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
• Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
• Confirmed testosterone < 100 ng/dL
• Body Mass Index (BMI) > 50
• Hemoglobin A1c (HbA1C) > 11%
• Hematocrit (Hct) > 50%
• Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
• History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).