Study of The Effects of Testosterone in Frail Elderly Men

Phase 4

Completed

• Conditions: Sarcopenia; Frailty
• Interventions: Drug: Transdermal testosterone gel (Testogel 1% ); Drug: Matched transdermal placebo gel

• Registration Number: NCT00190060
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief 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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-19
• Primary Completion: 2008-12-31
• Study Completion: 2008-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 262

Inclusion Criteria

• Frail elderly men (as defined by Freid's criteria of frailty)
• Community - dwelling men aged 65 years and above
• Total testosterone ≤12.0 nmol/L or calculated free T≤0.25nmol/L

Exclusion Criteria

• Carcinoma of prostate
• Carcinoma of breast
• PSA >4ng/mL
• Severe symptomatic benign prostatic hypertrophy (IPSS >21)
• Active liver disease
• Renal impairment (serum creatinine >180 mmol/L)
• Congestive heart failure
• Unstable ischaemic heart disease
• Polycythaemia
• Evidence of systemic disease which may affect muscle/joint function
• Moderate to severe peripheral vascular disease
• Moderate to severe chronic obstructive airways disease
• Alcohol consumption over 30 units per week
• Medications that interfere with sex steroid metabolism
• History of stroke causing persistent motor deficit
• Cognitive deficit
• Major psychiatric illness
• Hospital admission in the past 6 weeks
• Sleep apnoea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Transdermal testosterone gel (Testogel 1% )	Transdermal testosterone gel (Testogel 1% )
2	Matched transdermal placebo gel	Matched transdermal placebo gel

Primary Outcome Measures

Name	Time	Method
Lower limb muscle strength at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Bone Mineral Density	6 months
Total and regional lean body mass at 6 months	6 months
Upper limb muscle strength at 6 months	6 months
Improvement in physical performance	6 months
Quality of life at 6 months	6 months

Trial Locations

Locations (1)

Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom