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A total of 790 men 65 years and older with a serum testosterone concentration of less than 275 ng per deciliter were randomly assigned to receive testosterone gel or placebo gel for 1 year. Each man participated in one or more of three trials—the Sexual Function Trial, the Physical Function Trial, and the Vitality Trial; the latter trial included assessments of fatigue, positive and negative mood symptoms (as measured by the Positive and Negative Affect Scale, or PANAS), and depression level (measured by Patient Health Questionnaire 9, or PHQ-9) after 3, 6, 9, and 12 months of treatment.
Testosterone treatment increased serum testosterone levels to the mid-normal range for men 19 to 40 years of age during the treatment period. Among participants in the Vitality Trial, there were significant differences between the testosterone and placebo group in the PANAS positive affect score (mean difference, 0.47 points), the PANAS negative affect score (mean difference, −0.49 points), and the PHQ-9 depression score (mean difference, −0.72 points). The men who received testosterone were more likely than men who received placebo to report that their energy was better at the end of the trial.
These results, combined with the findings from the other trials, “should inform decisions about testosterone treatment for men 65 years of age or older whose levels are low for no apparent reason other than age. Such decisions will also require knowing the risks of testosterone treatment, which will necessitate larger and longer trials,” the authors concluded.
For related information, see the Psychiatric News article “Discontinuing Hormone Therapy May Increase Risk of Depression in Some Women.”
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