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Study of The Effects of Testosterone in Frail Elderly Men

This study has been completed.
University of Manchester
Information provided by:
Central Manchester University Hospitals NHS Foundation Trust Identifier:
First received: September 11, 2005
Last updated: November 29, 2007
Last verified: November 2007
The study aims to determine the effects of testosterone on muscle function, mobility, activities of daily living and overall quality of life

Condition Intervention Phase
Drug: Transdermal testosterone gel (Testogel 1% )
Drug: Matched transdermal placebo gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of The Effects of Testosterone on Muscle Function, Physical Performance, Body Composition and Quality of Life in Frail Elderly Men

Resource links provided by NLM:

Further study details as provided by Central Manchester University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Lower limb muscle strength at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Upper limb muscle strength at 6 months [ Time Frame: 6 months ]
  • Quality of life at 6 months [ Time Frame: 6 months ]
  • Total and regional lean body mass at 6 months [ Time Frame: 6 months ]
  • Improvement in physical performance [ Time Frame: 6 months ]
  • Bone Mineral Density [ Time Frame: 6 months ]

Enrollment: 262
Study Start Date: October 2004
Study Completion Date: March 2007
Arms Assigned Interventions
Active Comparator: 1
Transdermal testosterone gel (Testogel 1% )
Drug: Transdermal testosterone gel (Testogel 1% )
Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months
Other Name: Testogel 1%
Placebo Comparator: 2
Matched transdermal placebo gel
Drug: Matched transdermal placebo gel
Matched transdermal placebo gel, 50mg/d for 6 months

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.

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00190060

United Kingdom
Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Central Manchester University Hospitals NHS Foundation Trust
University of Manchester
Principal Investigator: Professor Frederick CW Wu, MD, FRCP Central Manchester and Manchester Children's University Hospitals Trust & The University of Manchester
Principal Investigator: Dr Martin Connolly, MD, FRCP Central Manchester and Manchester Children's University Hospitals Trust
Principal Investigator: Professor JA Oldham, PhD The University of Manchester
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Professor FCW Wu, Central Manchester and Manchester Children's University Hospitals NHS Trust Identifier: NCT00190060     History of Changes
Other Study ID Numbers: CMMCHUT PIN 9197
Study First Received: September 11, 2005
Last Updated: November 29, 2007

Keywords provided by Central Manchester University Hospitals NHS Foundation Trust:
Muscle strength
Physical performance
Bone mineral density
Quality of life

Additional relevant MeSH terms:
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on May 25, 2017