Gary M. Dailey, MD
15 Nov 96
Clinical Scenario:
An active, otherwise healthy 75 yr old man has heard in the lay press that testosterone
supplementation (TES) reverses the effects of aging, and wants to know if he would benefit
from TES.
Clinical Bottom Line(s):
1. There is a surprising paucity of studies of testosterone supplementation in
generally healthy elderly men.
One small, but substantive study did show a clear increase in lean body mass, lowered
total cholesterol and
LDL, as well as some weak, indirect evidence of decreased bone resorption.
2. Safety and sustained efficacy studies have not been published. Increased PSA levels have been reported with TES and therefore risk vs. benefit is still unclear today for eugonadal men. TES appears to be an area of arousing interest, and more data should be forthcoming.
3. There is some decent data showing improvement in sexual function in men with clearly documented hypogonadism receiving testosterone supplementation, this specific effect has not been clearly demonstrated in eugonadal men.
Double-blinded, placebo-controlled, crossover study of 13 healthy men ages 57-76yr,
recruited from
community with total testosterone level <13.9 nmol/L (nonnal 12.1 - 34.7), randomized
to 3 months of
weekly IM testosterone or placebo, then crossed-over for second 3 month period. Variables
measured before
and after each treatment. Statistical analysis by ANOVA.
| Parameter | Baseline | Treatment | Placebo | |
| Lean Body Mass (kg) | 56.5 +/-1.5 | 58.2+/-1.5 | 56.4 +/-1.4 | (1.7 kgn ave increase) |
| % body fat | no significant change | |||
| hydroxyproline/GFR | 151 +/-10 | 108 +/-8 | 142 +/-13 | |
| hematocrit | 43.1 +/-0.8 | 46.7 +/-1.1 | 43.2 +/-0.8 | |
| total cholesterol | 199 +/-6 | 177 +/-5 | 203 +/-6 | |
| LDL | 128 +/-7 | 113 +/-5 | 132 +/-7 | |
| HDL, Apo A-1, TG | no significant change | |||
| PSA (ng/ml) | 2.1 +/-0.4 | 2.7+/-0.5 | 2/6 +/-0.5 | |
No prostate abnormalities detected by digital exam or ultrasonography.
Other chemistry values related to bone showed no significant change.
all values listed demonstrated P < .001.
- TES dose determined from previous pilot study to 'boost' TE level from low normal to
normal levels.
Subsequently no acne, hair growth changes noted during study.
- 38% healthy men age >= 60 screened in study clinic had similar, low normal TE levels.
implying that this
degree of hypogonadism is fairly common in the study population.
- study was double-blinded, but 12 of 13 men correctly predicted TE treatment by increased
libido, sense of
well being, and aggressiveness in business transactions.
- PSA remained persistently elevated in 30% of study participants.
- Cost of TE treatment is low ($100-$200 per year), many hypogonadal men have been treated
since 1940's
1. Tenover JS, Effects of testosterone supplementation in the aging male. Journal of
Clinical Endocrinology &.
Metabolism, 1992 Oct;75(4):1092-8.
2. Arver ,S. Dobs, A.S., Meikle, A.W., Allen, R.P., Sanders S.W., Improvement of sexual function in testosterone deficient men treated for 1 year with a permeation enchanced testosterone transdermal system. Journal of Urology 1996 May; 155 (5): 1604-8.
3. Swerdloff, R.S., Wang C. , Androgen deficiency and aging in men [see
comments]. [Review] Western Journal of
Medicine 1993 Nov; 159 (5): 579-85, Comment in West J Med 1993 Nov; 159(5):618-20.