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Study of The Effects of Testosterone in Frail Elderly Men

This study has been completed.
Sponsor:
Collaborators:
University of Manchester
Bayer
Information provided by:
Central Manchester University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00190060
First received: September 11, 2005
Last updated: November 29, 2007
Last verified: November 2007

September 11, 2005
November 29, 2007
October 2004
Not Provided
Lower limb muscle strength at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Lower limb muscle strength at 6 months
Complete list of historical versions of study NCT00190060 on ClinicalTrials.gov Archive Site
  • Upper limb muscle strength at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total and regional lean body mass at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement in physical performance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Bone Mineral Density [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Upper limb muscle strength at 6 months
  • Physical performance at 6 months
  • Quality of life at 6 months
  • Total and regional lean body mass at 6 months
Not Provided
Not Provided
 
Study of The Effects of Testosterone in Frail Elderly Men
Study of The Effects of Testosterone on Muscle Function, Physical Performance, Body Composition and Quality of Life in Frail Elderly Men

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Frailty
  • Sarcopenia
  • Drug: Transdermal testosterone gel (Testogel 1% )
    Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months
    Other Name: Testogel 1%
  • Drug: Matched transdermal placebo gel
    Matched transdermal placebo gel, 50mg/d for 6 months
  • Active Comparator: 1
    Transdermal testosterone gel (Testogel 1% )
    Intervention: Drug: Transdermal testosterone gel (Testogel 1% )
  • Placebo Comparator: 2
    Matched transdermal placebo gel
    Intervention: Drug: Matched transdermal placebo gel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
262
March 2007
Not Provided

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
Male
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00190060
CMMCHUT PIN 9197, T0053/WTCRF
Yes
Professor FCW Wu, Central Manchester and Manchester Children's University Hospitals NHS Trust
Central Manchester University Hospitals NHS Foundation Trust
  • University of Manchester
  • Bayer
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
Central Manchester University Hospitals NHS Foundation Trust
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP