ABOUT THE STUDY
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 in males between the ages of 45 and 80 and who have a history or risk of heart disease or stroke, who do not produce enough testosterone (hypogonadal men) and have symptoms from not enough testosterone.
The study will also determine if the use of TRT affects 1) the chance of having prostate cancer and how serious it may be, and 2) the chance of having broken bones (fractures).
Other potential effects of TRT being studied include effect on sexual function, mood, anemia, and the tendency to develop diabetes. These effects will be examined in men who qualify. Thus, the goal of this study will be to learn more about the safety and overall effects of TRT.