Study of The Effects of Testosterone in Frail Elderly Men

• Status: Completed
• Trial end date: 2008-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust; Manchester University NHS Foundation Trust
• Collaborators: Bayer; University of Manchester
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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