Le Trac, Mercer University College of Pharmacy
Research has shown that testosterone levels decrease with age in men. Many conditions that are associated with low testosterone levels in men such as pituitary or testicular disease begin to be more prevalent with increasing age. It is suggested that testosterone treatment increases muscle mass and decrease fat mass. 
According to the Institute of Medicine (IOM), there is not enough evidence to suggest that testosterone treatment is beneficial in older men. The effects of testosterone on physical performance, sexual dysfunction, and energy are stated to be inconsistent. Thus, the IOM panel recommended initiating a set of clinical trials in order to determine the benefits of testosterone in older men. 
|Title: Effects of Testosterone Treatment in Older Men |
|Design||Double-blind, placebo-controlled, multicenter; N = 790|
|Objective||To determine the benefits of testosterone in older men who had low testosterone levels for no known reason other than age and who had clinical conditions due to low level of testosterone|
|Study Groups||Sexual Function Trial: testosterone (n= 193); placebo (n= 193)
Physical Function Trial: Testosterone (n= 172); placebo (n= 165)
Vitality Trial: Testosterone (n= 203); placebo (n= 191)
|Methods||Men 65 years of age or older with a serum testosterone concentration of less than 275 ng/dL and symptoms suggesting hypoandrogenism 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 Vitality Trial.|
|Primary Outcome Measure||The primary outcome of the Sexual Function Trial was the change from baseline in the score for sexual activity on the Psychosexual Daily Questionnaire (PDQ).
The primary outcome of the Physical Function Trial was the percentage of men who increased the distance walked in the 6-minute walk test by at least 50 m.
The primary outcome of the Vitality Trial was the percentage of men whose score on the FACIT (Functional Assessment of Chronic Illness Therapy)-Fatigue scale increased by at least four points.
|Results||Sexual Function Trial Outcomes
Physical Function Trial Outcomes
Vitality Trial Outcomes
|Adverse Events||Common Adverse Events: IPSS > 19 (27%), increase in PSA level by ≥1.0 ng/mL (23%), myocardial infarction, stroke, or death from cardiovascular causes (7%)|
|Serious Adverse Events: hospitalization (68%), death (3%), others (7%)|
|Percentage that Discontinued due to Adverse Events: N/A|
|Study Author 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 distance.|
Results of these trials showed that testosterone treatment had a moderate benefit to sexual function but no significant benefit in walking distance or vitality. Past studies have shown both an increased and decreased risk of cardiovascular side effects in patients who were taking testosterone. The sample size in this trial was too small to draw a definite result, and thus the risks of testosterone treatment should always be considered when initiating therapy.
 Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. J Clin Endocrinol Metab 2001;86:724-31.
 Snyder PJ, Ellenberg SS, Cunningham GR, et al. The Testosterone Trials: seven coordinated trials of testosterone treatment in elderly men. Clin Trials 2014;11: 362-75.
 Snyder PJ, Bhasin S, Cunningham GR, et al. Effects of Testosterone Treatment in Older Men. N Engl J Med. 2016; 374:611-624