Adverse events associated with testosterone administration

3 min

Background

Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. However, the safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied.

Aim

To report adverse events associated with testosterone treatment in a trial of older men with limited mobility. 

Methods

Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng/dl (3.5 to 12.1 nmol/L) or a free serum testosterone level of less than 50 pg/ml (173 pmol/L) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months.

Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification.

The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group.

Results

A total of 209 men (mean age=74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidaemia, and obesity among the participants.

During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group.

A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events; 7 men in the testosterone group and 1 in the placebo group had atherosclerosis-related events.

The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period.

As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press (trial primary outcome measure) and chest-press strength and in stair climbing while carrying a load.

Conclusion

In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events.

The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.

More for health practitioners

We offer a range of evidence-based resources for health practitioners to develop their understanding of male health.


Did you find this page helpful?

Information provided on this website is not a substitute for medical advice

Call 000 for emergency services

If you or someone you know needs urgent medical attention.

Call MensLine Australia on 1300 78 99 78 for 24/7 support

MensLine Australia is a telephone and online counselling service for men with emotional health and relationship concerns.

Sign up to our newsletter

We release two monthly newsletters – one written for men, family and friends, and another for health practitioners.

Your preferred mailing list

Your name

Your email

Stay up to date

FacebookInstagramLinkedinTwitterYoutubespotifytiktok

Healthy Male acknowledges the traditional owners of the land. We pay our respects to elders past, present and future. We are committed to providing respectful, inclusive services and work environments where all individuals feel accepted, safe, affirmed and celebrated. Aboriginal and Torres Strait Islander people should be aware that this website may contain images, voices and names of deceased persons.

Disclaimer

Healthy Male is funded by the Australian Government Department of Health and Aged Care. This website does not host any form of advertisement. Information provided on this website is not a substitute for medical advice.

Trusted information partner of