Newswise — The National Institutes of Health should fund a $100 million to $200 million Men's Health Initiative to determine the safety of long-term testosterone treatment for men, says one of the nation's foremost experts on testosterone replacement therapy.

John Morley, M.D., chair of the division of geriatric medicine at Saint Louis University School of Medicine and creator of the ADAM screening tool that helps detect low testosterone levels in men, says a Men's Health Initiative would give clear answers about the true effects of a hormone on the body's multiple systems.

"The delay in doing the Women's Health Initiative resulted in many women using an estrogen/progestagen combination to prevent heart disease when it clearly increased it," says Dr. Morley, an endocrinologist. "We have the opportunity not to make the same mistake in men."

An eight- to 10-year Men's Health Initiative should involve at least 16,000 to 20,000 men who have low testosterone. It should examine the effect of testosterone therapy on prostate cancer and cardiovascular disease as well as on improvements in mobility and decreases in spinal fractures, Dr. Morley says.

A small number of studies show testosterone replacement in men who are hypogonadal - or have low testosterone levels - improves libido and may enhance sexual function. It also appears to increase bone mineral density, muscle mass and strength, and may enhance cognition. However research to date has not documented whether testosterone replacement therapy has adverse side effects, such as increasing prostate cancer or heart disease, Dr. Morley says.

"There has been a marked increase in testosterone prescriptions in the last few years," Dr. Morley says. "With more new products n the horizon, the market is likely to grow exponentially over the next decade. It is likely to become a market of more than $1 billion a year within five years. Determine the safety of long-term testosterone treatment is the paramount reason for undertaking a Men's Health Initiative at this time."

The National Institutes of Health has asked the Institute of Medicine to study whether a large study on testosterone replacement therapy - similar to the Women's Health Initiative - is justified. Committee members have interviewed experts on testosterone therapy, including Dr. Morley, for about six months. A recommendation is expected in October.

Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first M.D. degree west of the Mississippi River. Saint Louis University School of Medicine is a pioneer in geriatric medicine, organ transplantation, chronic disease prevention, cardiovascular disease, neurosciences and vaccine research, among others. The School of Medicine trains physicians and biomedical scientists, conducts medical research, and provides health services on a local, national and international level.

Supplemental graphic (the ADAM screening tool) is available here: http://www.slu.edu/adam/maletquiz.pdf