Status:
COMPLETED
Study of The Effects of Testosterone in Frail Elderly Men
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
University of Manchester
Bayer
Conditions:
Frailty
Sarcopenia
Eligibility:
MALE
65+ years
Phase:
PHASE4
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2008
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT00190060
Start Date
October 1 2004
End Date
December 31 2008
Last Update
August 3 2018
Active Locations (1)
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1
Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL