Study of The Effects of Testosterone in Frail Elderly Men

NCT ID: NCT00190060

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2008-12-31

Brief Summary

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

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.

Conditions

Frailty; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Transdermal testosterone gel (Testogel 1% )

Group Type: ACTIVE_COMPARATOR

Transdermal testosterone gel (Testogel 1% )

Intervention Type: DRUG

Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months

2

Matched transdermal placebo gel

Group Type: PLACEBO_COMPARATOR

Matched transdermal placebo gel

Intervention Type: DRUG

Matched transdermal placebo gel, 50mg/d for 6 months

Interventions

Transdermal testosterone gel (Testogel 1% )

Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months

Intervention Type: DRUG

Matched transdermal placebo gel

Matched transdermal placebo gel, 50mg/d for 6 months

Intervention Type: DRUG

Other Intervention Names

Testogel 1%

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manchester

OTHER

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor Frederick CW Wu, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Central Manchester and Manchester Children's University Hospitals Trust & The University of Manchester

Dr Martin Connolly, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Central Manchester and Manchester Children's University Hospitals Trust

Professor JA Oldham, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Manchester

Locations

Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary

Manchester, , United Kingdom

Countries

United Kingdom

References

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. doi: 10.1093/gerona/56.3.m146.

Reference Type: BACKGROUND

PMID: 11253156 (View on PubMed)

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. doi: 10.1210/jcem-59-5-955.

Reference Type: BACKGROUND

PMID: 6480814 (View on PubMed)

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. doi: 10.1046/j.1365-2605.1999.00177.x.

Reference Type: BACKGROUND

PMID: 10442299 (View on PubMed)

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. doi: 10.1152/ajpendo.2001.281.6.E1172.

Reference Type: BACKGROUND

PMID: 11701431 (View on PubMed)

O'Connell MD, Roberts SA, Srinivas-Shankar U, Tajar A, Connolly MJ, Adams JE, Oldham JA, Wu FC. Do the effects of testosterone on muscle strength, physical function, body composition, and quality of life persist six months after treatment in intermediate-frail and frail elderly men? J Clin Endocrinol Metab. 2011 Feb;96(2):454-8. doi: 10.1210/jc.2010-1167. Epub 2010 Nov 17.

Reference Type: DERIVED

PMID: 21084399 (View on PubMed)

Other Identifiers

T0053/WTCRF

Identifier Type: -

Identifier Source: secondary_id

CMMCHUT PIN 9197

Identifier Type: -

Identifier Source: org_study_id