Testosterone Trial
Trial question
What is the role of testosterone treatment in older men?
Study design
Multi-center
Double blinded
RCT
Population
790 male patients.
Inclusion criteria: men ≥ 65 years of age with serum testosterone concentration of < 275 ng/dL and symptoms suggesting hypoandrogenism.
Key exclusion criteria: history of prostate cancer, a risk of all prostate cancer of > 35% or of high-grade prostate cancer of > 7% as determined according to the Prostate Cancer Risk Calculator, an IPSS (IPSS; range, 0-35, with higher scores indicating more severe symptoms of BPH) of > 19, conditions known to cause hypogonadism, receipt of medications that alter the testosterone concentration, or high cardiovascular risk.
Interventions
N=395 testosterone gel (AndroGel 1% with an initial dose of 5 g daily).
N=395 placebo (similar application and appearance to AndroGel).
Primary outcome
Change in score on Psychosexual Daily Questionnaire
0.2 points
-0.1 points
0.2 points
0.2 points
0.1 points
0.1 points
0.0 points
-0.1 points
-0.1 points
Testosterone
gel
Placebo
Significant
increase ▲
Significant increase in change in score on the Psychosexual Daily Questionnaire (0.2 points vs. -0.1 points).
Secondary outcomes
No significant difference in the percentage of patients achieving an improvement of at least 50 m in 6MWD (20.3% vs. 12.1%; OR 1.42, 95% CI 0.83 to 2.45).
No significant difference in the percentage of patients achieving an improvement of least 4 points on the Functional Assessment of Chronic Illness Therapy-Fatigue scale (72.4% vs. 62.8%; OR 1.23, 95% CI 0.83 to 1.84).
Safety outcomes
No significant difference in rates of adverse events.
Conclusion
In men ≥ 65 years of age with serum testosterone concentration of < 275 ng/dL and symptoms suggesting hypoandrogenism, testosterone gel was superior to placebo with respect to change in score on the Psychosexual Daily Questionnaire.
Reference
Snyder PJ, Bhasin S, Cunningham GR et al. Effects of Testosterone Treatment in Older Men. N Engl J Med. 2016 Feb 18;374(7):611-24.
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