Study of The Effects of Testosterone in Frail Elderly Men

August 1, 2018 updated by: Manchester University NHS Foundation Trust

Study of The Effects of Testosterone on Muscle Function, Physical Performance, Body Composition and Quality of Life in Frail Elderly Men

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

262

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Testogel 1%
PLACEBO_COMPARATOR: 2
Matched transdermal placebo gel
Drug: Matched transdermal placebo gel
Matched transdermal placebo gel, 50mg/d for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lower limb muscle strength at 6 months
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Bone Mineral Density
Time Frame: 6 months
6 months
Upper limb muscle strength at 6 months
Time Frame: 6 months
6 months
Quality of life at 6 months
Time Frame: 6 months
6 months
Total and regional lean body mass at 6 months
Time Frame: 6 months
6 months
Improvement in physical performance
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manchester University NHS Foundation Trust

Collaborators

Bayer
University of Manchester

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

December 31, 2008

Study Completion (ACTUAL)

December 31, 2008

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (ESTIMATE)

September 19, 2005

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMMCHUT PIN 9197
  • T0053/WTCRF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Frailty

Clinical Trials on Transdermal testosterone gel (Testogel 1% )

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe