Study of The Effects of Testosterone in Frail Elderly Men

NCT00190060 | Completed Phase 4 DMC

• 2 other identifiers: CMMCHUT PIN 9197T0053/WTCRF
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Frailty; Sarcopenia

Keywords

Frailty; Muscle strength; Physical performance; Bone mineral density; Quality of life

Outcome Measures

Primary Outcomes (1)

• Lower limb muscle strength at 6 months

  6 months

Secondary Outcomes (5)

• Upper limb muscle strength at 6 months

  6 months

• Quality of life at 6 months

  6 months

• Total and regional lean body mass at 6 months

  6 months

• Improvement in physical performance

  6 months

• Bone Mineral Density

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Transdermal testosterone gel (Testogel 1% )

Drug: Transdermal testosterone gel (Testogel 1% )

2

PLACEBO COMPARATOR

Matched transdermal placebo gel

Drug: Matched transdermal placebo gel

Interventions

Transdermal testosterone gel (Testogel 1% ) DRUG

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

Also known as: Testogel 1%

1

Matched transdermal placebo gel DRUG

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

2

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Manchester: collaborator
• Bayer: collaborator

Study Sites (1)

Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 11253156 BACKGROUND

• 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.

  PMID: 6480814 BACKGROUND

• 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.

  PMID: 10442299 BACKGROUND

• 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.

  PMID: 11701431 BACKGROUND

• 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.

  PMID: 21084399 DERIVED

MeSH Terms

Conditions

Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 19, 2005
• Study Start: October 1, 2004
• Primary Completion: December 31, 2008
• Study Completion: December 31, 2008
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

GB (1)