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| ID | Type | Description | Link |
|---|---|---|---|
| T0053/WTCRF |
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| Name | Class |
|---|---|
| University of Manchester | OTHER |
| Bayer | INDUSTRY |
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The study aims to determine the effects of testosterone on muscle function, mobility, activities of daily living and overall quality of life
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Transdermal testosterone gel (Testogel 1% ) |
|
| 2 | Placebo Comparator | Matched transdermal placebo gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal testosterone gel (Testogel 1% ) | Drug | Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lower limb muscle strength at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11253156 | Background | 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. | |
| 6480814 | Background |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
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| Matched transdermal placebo gel | Drug | Matched transdermal placebo gel, 50mg/d for 6 months |
|
| 6 months |
| Improvement in physical performance | 6 months |
| Bone Mineral Density | 6 months |
| 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. |
| 10442299 | 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. |
| 11701431 | 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. |
| 21084399 | Derived | 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. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |