Men older than 65 on testosterone replacement therapy to boost their hormone levels to that of much younger men enjoy a spike in libido, sexual activity and mood, but the side effects remain a concern, according to a new testosterone study published in the New England Journal of Medicine.
The new study, dubbed the Testosterone Trials (TTrials) was led by researchers from the University of Pennsylvania and included 790 men who were randomized to use either AbbVie’s Androgel topical testosterone gel for one year, or a placebo for a year. Participants were evaluated four times during that time and filled out questionnaires to report symptoms. Seven parameters were measured – physical function, vitality, sexual function, cognitive function, anemia, cardiovascular health and bone health.
The men in the study were age 65 and older. As men age, their testosterone levels naturally drop, a condition known as hypogonadism. Age-related hypogonadism is not an indication for testosterone treatments. The therapy is only FDA-approved to treat men who have hypogonadism caused by injury or disease. Despite this, researchers gave the participants who were treated with AndroGel enough to boost their testosterone level to what would be considered normal for men between the ages of 19 and 40.
Researchers found that men who were treated with AndroGel reported “significantly increased sexual activity” as well as more desire for sex and improved erectile dysfunction. They also reported better mood and less depression.
Cardiovascular and bone health was not evaluated in the published report. Those findings are expected to be published in future papers. However critics say a year-long test is not enough to fully gauge testosterone side effects.
Previous studies on testosterone supplements have found that men on testosterone therapy were 30 percent more likely to have a heart attack, stroke or die after three years of use. Another study found a significantly increased risk of heart attack and stroke in the first 90 days of treatment.
AbbVie and other manufacturers of testosterone products are facing thousands of lawsuits claiming they aggressively marketed the treatments to men, creating a new indication – Low T – to increase sales but failed to adequately warn men of testosterone side effects.