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Sponsors and Collaborators: |
Central Manchester and Manchester Children's University hospitals NHS Trust The University of Manchester, Manchester, UK Bayer Schering Pharmaceutical |
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Information provided by: | Central Manchester and Manchester Children's University hospitals NHS Trust |
ClinicalTrials.gov Identifier: | NCT00190060 |
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 |
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Frailty Sarcopenia |
Drug: Transdermal testosterone gel (Testogel 1% ) Drug: Matched transdermal placebo gel |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Study of The Effects of Testosterone on Muscle Function, Physical Performance, Body Composition and Quality of Life in Frail Elderly Men |
Enrollment: | 262 |
Study Start Date: | October 2004 |
Study Completion Date: | March 2007 |
Arms | Assigned Interventions |
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1: Active Comparator
Transdermal testosterone gel (Testogel 1% )
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Drug: Transdermal testosterone gel (Testogel 1% )
Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months
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2: Placebo Comparator
Matched transdermal placebo gel
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Drug: Matched transdermal placebo gel
Matched transdermal placebo gel, 50mg/d for 6 months
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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 |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary | |
Manchester, United Kingdom, M13 9WL |
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 |
Responsible Party: | Central Manchester and Manchester Children's University Hospitals NHS Trust ( Professor FCW Wu ) |
Study ID Numbers: | CMMCHUT PIN 9197, T0053/WTCRF |
Study First Received: | September 11, 2005 |
Last Updated: | November 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00190060 |
Health Authority: | United Kingdom: National Health Service |
Frailty Muscle strength Physical performance Bone mineral density Quality of life |
Testosterone Quality of Life Methyltestosterone Testosterone 17 beta-cypionate |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |