FrailtyPhase 4NCT00190060
Study of The Effects of Testosterone in Frail Elderly Men
A Phase 4 study testing Transdermal testosterone gel (Testogel 1% ) in people with Frailty and Sarcopenia, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The study aims to determine the effects of testosterone on muscle function, mobility, activities of daily living and overall quality of life Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Frailty, Sarcopenia
- What is being tested?
- Transdermal testosterone gel (Testogel 1% )
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2004to 31 Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary
Manchester, M13 9WL
About this study
Official title: 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
Read the 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
- Being tested
- Transdermal testosterone gel (Testogel 1% ), Matched transdermal placebo gel
- Keywords
- Frailty, Muscle strength, Physical performance, Bone mineral density, Quality of life
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal testosterone gel (Testogel 1% )Drug
Also called Testogel 1%
Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months
Matched transdermal placebo gelDrug
Matched transdermal placebo gel, 50mg/d for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Transdermal testosterone gel (Testogel 1% ) Receives: Drug: Transdermal testosterone gel (Testogel 1% ) |
| 2 | Placebo comparator | Matched transdermal placebo gel Receives: Drug: Matched transdermal placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limb muscle strength at 6 months
Measured: 6 months
Secondary outcomes (5)
Upper limb muscle strength at 6 months
Measured: 6 months
Quality of life at 6 months
Measured: 6 months
Total and regional lean body mass at 6 months
Measured: 6 months
Improvement in physical performance
Measured: 6 months
Bone Mineral Density
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startOct 2004
- Primary completion31 Dec 2008
- Study completion31 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Manchester, Bayer
- Responsible party
- Sponsor
- Investigators
- Professor Frederick CW Wu, MD, FRCP, Principal investigator, Central Manchester and Manchester Children's University Hospitals Trust & The University of ManchesterDr Martin Connolly, MD, FRCP, Principal investigator, Central Manchester and Manchester Children's University Hospitals TrustProfessor JA Oldham, PhD, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190060
- Sponsor's protocol ID
- CMMCHUT PIN 9197
- Other IDs
- T0053/WTCRF
- Status last verified
- Aug 2018
- First submitted
- 11 Sep 2005
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Deslypere 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.
PubMed 6480814Clague 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.
PubMed 10442299Bhasin 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.
PubMed 11701431O'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.
PubMed 21084399
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of The Effects of Testosterone on Muscle Function, Physical Performance, Body Composition and Quality of Life in Frail Elderly Men
- ClinicalTrials.gov ID
- NCT00190060
- Acronym / sponsor ID
- CMMCHUT PIN 9197
- Conditions
- Frailty, Sarcopenia
- Keywords
- Frailty, Muscle strength, Physical performance, Bone mineral density, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Manchester, Bayer
- Study start
- Oct 2004
- Primary completion
- 31 Dec 2008 (actual)
- Study completion
- 31 Dec 2008 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Transdermal testosterone gel (Testogel 1% )Transdermal testosterone gel (Testogel 1% ) |
| 2 | Placebo comparator | Drug: Matched transdermal placebo gelMatched transdermal placebo gel |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- Carcinoma of prostate
- Carcinoma of breast
- PSA >4ng/mL
- Severe symptomatic benign prostatic hypertrophy (IPSS >21)
- Active liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal testosterone gel (Testogel 1% )Also: Testogel 1%Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months | Drug | 1 |
| Matched transdermal placebo gelMatched transdermal placebo gel, 50mg/d for 6 months | Drug | 2 |
Primary outcome
Lower limb muscle strength at 6 months
Time frame: 6 months
5 secondary outcomes
Upper limb muscle strength at 6 months
Time frame: 6 months
Quality of life at 6 months
Time frame: 6 months
Total and regional lean body mass at 6 months
Time frame: 6 months
Improvement in physical performance
Time frame: 6 months
Bone Mineral Density
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Background: PubMed 11253156Fried 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.
- Background: PubMed 6480814Deslypere 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.
- Background: PubMed 10442299Clague 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.
- Background: PubMed 11701431Bhasin 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.
- Derived from this study: PubMed 21084399O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Frederick CW Wu, MD, FRCP principal investigator
Central Manchester and Manchester Children's University Hospitals Trust & The University of Manchester
Dr Martin Connolly, MD, FRCP principal investigator
Central Manchester and Manchester Children's University Hospitals Trust
Professor JA Oldham, PhD principal investigator
The University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transdermal testosterone gel (Testogel 1% ) in people with Frailty and Sarcopenia, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower limb muscle strength at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00190060, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.