BACKGROUND:
Serum testosterone concentrations decrease as men age, but benefits of raising testos-
terone levels in older men have not been established.
METHODS:
We assigned 790 men 65 years of age or older with a serum testosterone concentration
of less than 275 ng per deciliter and symptoms suggesting hypoandrogenism to receive
either 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 Vital-
ity Trial. The primary outcome of each of the individual trials was also evaluated in all
participants.
RESULTS:
Testosterone treatment increased serum testosterone levels to the mid-normal range for
men 19 to 40 years of age. The increase in testosterone levels was associated with sig-
nificantly increased sexual activity, as assessed by the Psychosexual Daily Questionnaire
(P<0.001), as well as significantly increased sexual desire and erectile function. The
percentage of men who had an increase of at least 50 m in the 6-minute walking dis-
tance did not differ significantly between the two study groups in the Physical Function
Trial but did differ significantly when men in all three trials were included (20.5% of
men who received testosterone vs. 12.6% of men who received placebo, P=0.003). Tes-
tosterone had no significant benefit with respect to vitality, as assessed by the Func-
tional Assessment of Chronic Illness Therapy–Fatigue scale, but men who received tes-
tosterone reported slightly better mood and lower severity of depressive symptoms than
those who received placebo. The rates of adverse events were similar in the two groups.
CONCLUSIONS:
In symptomatic men 65 years of age or older, raising testosterone concentrations for
1 year from moderately low to the mid-normal range for men 19 to 40 years of age had
a moderate benefit with respect to sexual function and some benefit with respect to
mood and depressive symptoms but no benefit with respect to vitality or walking dis-
tance. The number of participants was too few to draw conclusions about the risks of
testosterone treatment. (Funded by the National Institutes of Health and others;
ClinicalTrials.gov number, NCT00799617.)
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