Study of The Effects of Testosterone in Frail Elderly Men

NHS Foundation Trust

Status and phase: Completed; Phase 4

Conditions: Frailty; Sarcopenia

Treatments: Drug: Transdermal testosterone gel (Testogel 1% ); Drug: Matched transdermal placebo gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00190060

T0053/WTCRF

CMMCHUT PIN 9197

Details and patient eligibility

About

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

Full 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.

Enrollment: 262 patients

Sex: Male

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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262 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Transdermal testosterone gel (Testogel 1% )

Treatment:

Drug: Transdermal testosterone gel (Testogel 1% )

2

Placebo Comparator group

Description:

Matched transdermal placebo gel

Treatment:

Drug: Matched transdermal placebo gel