Years in the making, the National Institutes of Health is recruiting for the Testosterone Trial, or T Trial. It is a great sign that the mistakes made with hormone replacement therapy in women--may not be repeated in men.
"This is a very important study and it should be supported," said H. Ballentine Carter, MD, professor of urology at Johns Hopkins Medical Institution, who consulted on designing the trial. Dr. Carter has underscored the importance of clinical trials before making a medication like this more widely available.
Peter Snyder, MD, principal investigator at the T Trial Coordinating Center, and professor of endocrinology at the University of Pennsylvania, Philadelphia, explained the background and rationale for the trial. "As men get older, there is a very slow decrease in their testosterone levels. With it, men develop abnormalities in physical functioning, sexual function, and cognition. Some men become diabetic, and may become anemic."
"One important question is whether decreasing testosterone levels are part of normal aging--not pathologic, a normal consequence and even adaptive," said Dr. Snyder. Another possibility is that low testosterone levels result in frank hypogonadism, fatigue, and loss of physical function. The hypothesis that we are working with is whether men who are 65 years or older and have low serum testosterone concentrations will improve their physical function, sexual function, vitality, cognitive function, and low hemoglobin concentration, as well as decrease risk factors for cardiovascular disease and diabetes."
According to Dr. Snyder, men who are age 65 and older and have low blood testosterone, may be eligible for the trial if they also have one or more of the following: difficulty walking a quarter of a mile, less interest in sex, or less vitality than they used to have. However, there are important exclusion criteria as well.
If you are accepted into the trial, you will be randomly assigned to receive a testosterone gel (AndroGel®, Solvay Pharmaceuticals) or a placebo that will be applied daily. You will be followed for a year. Over the course of the year, men will be tested by questionnaires and blood tests to determine if their walking, interest in sex, energy, memory and blood count are getting better.
Testing Efficacy First
The T trial follows recommendations from an Institute of Medicine Panel calling for "first establishing clear benefit before assessing long-term risks" and to testing testosterone as a therapeutic intervention in men most likely to benefit."
In other words, if efficacy remains unproven, there will not be a large-scale trial like the Women's Health Initiative, which followed thousands of women for years and was extremely costly. That trial would be moot, according to Dr. Snyder, if testosterone does not prove efficacious.
Up Against Testosterone Proponents
The trial comes on the heels of intense promoting of testosterone as a miracle vitality drug for men--both as a preventative and treatment drug. Books and articles have targeted the men's consumer press. Testosterone replacement therapy has been taken up frequently at large medical meetings and Continuing Medical Education programs. Perhaps, a short, well-controlled trial with clear results will put the issue of efficacy to rest.
A total of 800 men at 12 sites around the United States will be enrolled in the trial. To see if there is a study center to contact in your area, check the T Trial site.