Pennsylvania researchers find benefits to testosterone treatments

Pennsylvania researchers found that testosterone gel — especially for retirement-age men — can make life a little funkier.

University of Pennsylvania researchers in February found for the first time that men over the age of 65 who use testosterone gels improved their mood, sexual function and ability to walk in a nationwide study they conducted  at 12 institutions — including Pitt’s Graduate School of Public Health.  The clinical trial, which was published on Feb. 18 in the New England Journal of Medicine, added to previous findings of the benefits of testosterone treatment in younger men. Jane Cauley, a professor in Pitt Public Health’s Department of Epidemiology, served as the prinicpal investigator at the Pittsburgh site.

The researchers conducted the clinical trial to determine if older men could benefit from testosterone treatments, as testosterone levels naturally decline as men age. While the researchers found that men over 65 could benefit, the trial was too small to determine any risks involved, according to the study.

“The results of the TT trials show for the first time that testosterone treatment of older men who have unequivocally low testosterone levels does have some benefit,” Peter Snyder, lead author and principal investigator of the testosterone trials (called TTrials) and professor in the Division of Endocrinology, Diabetes and Metabolism at Penn, said.

A grant from the National Institute on Aging, a branch of the National Institute of Health, funded the study, as well as the National Heart, Lung and Blood Institute, National Institute of Neurological Disorders and Stroke and National Institute of Child Health and Human Development.

The trial recruited 790 men with low testosterone levels through mass mailings. Of the participants, 78 were from and tested in Pittsburgh.The researchers randomly split the participants into two groups ­— one group received a testosterone gel intended to increase concentration of testosterone, and the other a placebo gel.

These men applied the gel to their skin every day for one year and researchers assessed symptoms of low testosterone levels, including sexual and physical function as well as mood and depressive symptoms. The researchers also tested how far the participants could walk in six minutes to assess walking ability.

Cauley said previous testosterone trials had ambiguous and inconsistent results about the impact of treatment for older men.

“Our study was an attempt to define the benefits in a rigorous clinical trial of older men, [whereas] many [other] studies focused on men in their 40s and 50s,” Cauley said.

Cauley said incidences of cardiovascular events and prostate conditions were similar in both groups.

“Our trial was too small to test whether testosterone treatment increases [the] risk of prostate cancer in older men. In addition, we specifically excluded men who may have been at high risk of prostate cancer. Our goal was to look at intermediate endpoints,” Cauley said.

In addition to the Pittsburgh site, the researchers held trials at 11 other sites, including the Baylor College of Medicine, the University of Florida College of Medicine and the Yale School of Medicine.

Matt Cestra, CEO and co-founder of ReGenesis Hormone Replacement Therapy in McMurray, Pennsylvania, which provides hormone replacement therapy for men and women, said men with symptoms tend to seek testosterone treatments in their late 30s to 50s. Cestra said for more men to receive testosterone treatment, more primary care physicians must educate themselves on the procedure.

“Physicians don’t know much about the treatments and are often afraid to prescribe the treatments, so men go out and get them on their own,” Cestra said.

According to Cestra, most men will get intramuscular testosterone injections once a week as the drug only lasts in the blood for seven to 10 days.

Cauley hopes men experiencing symptoms, such as decreased sexual drive, walking ability and mood, will get their testosterone levels checked and consider hormone treatment.

“Testosterone treatments [are] given widely in the community. Ads are always on TV pushing testosterone treatment to older men,” Cauley said. “If they have the symptoms that we focused on, they should go have their testosterone level measured.”