Clinical Trial Information
Principal Investigator: Peter J. Snyder, MD
Title: The Testosterone Trial
Purpose: As men age their blood testosterone levels fall, and also they find it more difficult to walk, have less energy, have less interest in sex, have greater difficulty remembering, and tend to be anemic, as well as greater risk of cardiovascular disease. It is possible that low blood testosterone is a cause of these problems. The purpose of The Testosterone Trial is to determine if testosterone treatment of men who are 65 years and older – and who have a low blood testosterone and one or more of these problems – will improve them.
Brief Description: The Testosterone Trial is a multicenter study of six coordinated trials of the effects of testosterone in elderly men with low testosterone on physical function, vitality, sexual function, cognitive function, anemia, and cardiovascular risk. Eight hundred men ≥65 years whose serum testosterone is <250 ng/dL are being randomized to receive testosterone or placebo double blindly for one year. The primary end points for each trial are distance walked in 6 minutes, fatigue-vitality, sexual activity, delayed verbal memory, hemoglobin, and coronary artery plaque burden. There are also several secondary end points for each trial.
Eligibility: To qualify for The Testosterone Trial, a man must be 65 years or older and have a serum testosterone concentration less than 250 ng/dL at 8AM on two occasions. He must also have symptoms and measured functional impairments in walking, sexual interest, or vitality. Men must also be at relatively low risk for prostate cancer and not have severe lower urinary tract symptoms.
Treatment: Men who qualify and agree to participate will be assigned randomly to receive either a testosterone gel or a placebo gel for one year. The dose of testosterone gel will be adjusted to keep the serum testosterone concentration within the normal range for young men.
This trial, called The Testosterone Trial, or TTrial, will be conducted in 800 men in 12 cities across the United States.
To find a trial site or more information, please visit The Official T Trial site.