Study of The Effects of Testosterone in Frail Elderly Men - Full Text View

Sponsors and Collaborators:	Central Manchester and Manchester Children's University hospitals NHS Trust The University of Manchester, Manchester, UK Bayer Schering Pharmacuetical
Information provided by:	Central Manchester and Manchester Children's University hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT00190060

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Minerals

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Central Manchester and Manchester Children's University hospitals NHS Trust:

Primary Outcome Measures:

Lower limb muscle strength at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	262
Study Start Date:	October 2004
Study Completion Date:	March 2007

Arms	Assigned Interventions
1: Active Comparator Transdermal testosterone gel (Testogel 1% )	Drug: Transdermal testosterone gel (Testogel 1% ) Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months
2: Placebo Comparator 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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190060

Locations

United Kingdom
Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL

Sponsors and Collaborators

Central Manchester and Manchester Children's University hospitals NHS Trust

The University of Manchester, Manchester, UK

Bayer Schering Pharmacuetical

Investigators

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:

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56.

Deslypere JP, Vermeulen A. Leydig cell function in normal men: effect of age, life-style, residence, diet, and activity. J Clin Endocrinol Metab. 1984 Nov;59(5):955-62.

Clague JE, Wu FC, Horan MA. Difficulties in measuring the effect of testosterone replacement therapy on muscle function in older men. Int J Androl. 1999 Aug;22(4):261-5.

Bhasin S, Woodhouse L, Casaburi R, Singh AB, Bhasin D, Berman N, Chen X, Yarasheski KE, Magliano L, Dzekov C, Dzekov J, Bross R, Phillips J, Sinha-Hikim I, Shen R, Storer TW. Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab. 2001 Dec;281(6):E1172-81.

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 History of Changes
Health Authority:	United Kingdom: National Health Service

Keywords provided by Central Manchester and Manchester Children's University hospitals NHS Trust:

Frailty
Muscle strength
Physical performance
Bone mineral density
Quality of life

Study placed in the following topic categories:

Anabolic Agents
Testosterone
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Quality of Life
Methyltestosterone
Hormones
Androgens
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents
Testosterone
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Hormones
Pharmacologic Actions
Androgens
Testosterone 17 beta-cypionate

ClinicalTrials.gov processed this record on September 02, 2009