Research Center: Village Health Partners
Location: 5425 W. Spring Creek Pkwy, Suite 200, Plano, TX 75024
Lead Doctor: Dr. Madhavi Ampajwala
IRB Committee: This study has been reviewed and approved by QUORUM REVIEW Institutional Review Board

Background

Testosterone levels have been shown to decline in men’s body as they get older. For many men, this natural decline does not necessarily mean they have low testosterone (or hypogonadism). However, some men have decreased production of testosterone below certain levels that causes noticeable symptoms or health effects. This condition is called low testosterone (hypogonadism).

The primary purpose of this study is to compare the effect of testosterone replacement therapy (TRT) versus placebo on men with a history or risk of heart disease or stroke.

This study seeks men aged 45-80 years old. Participants are required to attend 17 study visits at the research site over a 5 year period and might be eligible for some compensation for participation. 

Why Participate? 

• You may experience an improvement in your low testosterone symptoms, however this is not guaranteed 
• You will be helping researchers to understand the effects of testosterone treatment on cardiovascular health in men 
• You will be supporting research in men’s health and helping to better understand treatment options for those at risk for cardiovascular events 
• You will be helping to advance medical research.

Your Rights

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by the law.
• You will receive study-required medical care from a doctor 

Who Can Participate?

• Men aged 45-80
• May be experiencing symptoms of low testosterone (decreased sexual desire, low energy or mood, loss of body or facial hair, hot flashes, spontaneous erections, etc.) 
• Currently have a cardiovascular disease Able to attend 17 study visits at the research site over approximately 5 years