NCT00190060

Study of The Effects of Testosterone in Frail Elderly Men

Study of The Effects of Testosterone on Muscle Function, Physical Performance, Body Composition and Quality of Life in Frail Elderly Men

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The study aims to determine the effects of testosterone on muscle function, mobility, activities of daily living and overall quality of life

Detailed description

Ageing-associated loss of muscle mass and strength is a major cause of physical frailty, disability, morbidity and dependency in the elderly. This is associated with increased falls, fractures, loss of mobility, restricted activities of daily living and increased utilisation of healthcare resources. It is well known that serum testosterone levels fall with advancing age and this may be an important cause for muscle wasting and weakness (sarcopenia). Testosterone replacement increases muscle mass and improves muscle strength in young hypogonadal men. In relatively healthy elderly men, some short-term studies have also shown that testosterone can improve muscle strength. The potential beneficial effects of testosterone supplementation on muscle strength and functional capacity of frail elderly men has so far not been studies and forms the basis of this research. We hypothesise that testosterone supplementation is an effective, safe and economic anabolic intervention in frail elderly men with low circulating testosterone.

Conditions

• Frailty
• Sarcopenia

Interventions

Type	Name	Description
DRUG	Transdermal testosterone gel (Testogel 1% )	Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months
DRUG	Matched transdermal placebo gel	Matched transdermal placebo gel, 50mg/d for 6 months

Timeline

• Start date: 2004-10-01
• Primary completion: 2008-12-31
• Completion: 2008-12-31
• First posted: 2005-09-19
• Last updated: 2018-08-03

Locations

1 site across 1 country: United Kingdom