OBJECTIVES: Testosterone replacement therapy (TRT) is not yet approved for the treatment of low testosterone due to ageing alone. Despite this, a rapid growth of TRT use in older men has been reported, particularly in the United States, aiming to improve bone mineral density, diabetes mellitus, sexual function, body composition and quality of life. This research aims to explore whether TRT is an effective anti-ageing treatment in men. Specific objectives include: to explore the impact of TRT on various morbidities associated with ageing men; to examine treatment factors of TRT (such as dose, treatment length) on its effectiveness; and to conduct an economic evaluation to assess the cost-effectiveness of TRT as an anti-fracture agent.

METHODS: A comprehensive search of MEDLINE, PsycINFO and EMBASE was undertaken in October 2015 which identified 224 studies; studies were classified by the morbidity and clinical area investigated and categorised by evidence level. Randomised controlled trials were primarily used to assess treatment effectiveness. The economic evaluation compared intramuscular testosterone undecanoate to no treatment. Direct treatment costs were calculated and fracture risk reduction estimates (using FRAX® tool) made for a series of example patients with differing characteristics using an economic model.

RESULTS: Treatment length, dose and administration route of TRT were important factors in bone mineral density changes. However, studies measuring changes in metabolic parameters of men with diabetes reported conflicting findings and there was little evidence of effectiveness regarding the other morbidities associated with ageing. Safety concerns regarding cardiovascular risk remain uncertain. TRT was not found to be a cost-effective anti-fracture treatment, with calculated costs per hip fracture avoided estimates ranging from £75,000-£600,000.

CONCLUSIONS: The evidence base remains insufficient for TRT via any route to be confirmed as an effective anti-ageing treatment and so its use for this purpose should be limited at this time.