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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


Further study details as provided by Central Manchester University Hospitals NHS Foundation 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
Active Comparator: 1
Transdermal testosterone gel (Testogel 1% )
Drug: Transdermal testosterone gel (Testogel 1% )
Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months
Other Name: Testogel 1%
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 University Hospitals NHS Foundation Trust
University of Manchester
Bayer
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor FCW Wu, Central Manchester and Manchester Children's University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00190060     History of Changes
Other Study ID Numbers: CMMCHUT PIN 9197, T0053/WTCRF
Study First Received: September 11, 2005
Last Updated: November 29, 2007
Health Authority: United Kingdom: National Health Service

Keywords provided by Central Manchester University Hospitals NHS Foundation Trust:
Frailty
Muscle strength
Physical performance
Bone mineral density
Quality of life

Additional relevant MeSH terms:
Sarcopenia
Atrophy
Muscular Atrophy
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014