Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:48 AM
Study NCT ID:
NCT00190060
Status:
COMPLETED
Last Update Posted:
2018-08-03
First Post:
2005-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of The Effects of Testosterone in Frail Elderly Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2008-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower limb muscle strength at 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Upper limb muscle strength at 6 months', 'timeFrame': '6 months'}, {'measure': 'Quality of life at 6 months', 'timeFrame': '6 months'}, {'measure': 'Total and regional lean body mass at 6 months', 'timeFrame': '6 months'}, {'measure': 'Improvement in physical performance', 'timeFrame': '6 months'}, {'measure': 'Bone Mineral Density', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Frailty', 'Muscle strength', 'Physical performance', 'Bone mineral density', 'Quality of life'], 'conditions': ['Frailty', 'Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '11253156', 'type': 'BACKGROUND', 'citation': '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': '6480814', 'type': 'BACKGROUND', 'citation': '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': '10442299', 'type': 'BACKGROUND', 'citation': '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': '11701431', 'type': 'BACKGROUND', 'citation': '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': '21084399', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': 'The study aims to determine the effects of testosterone on muscle function, mobility, activities of daily living and overall quality of life', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Frail elderly men (as defined by Freid's criteria of frailty)\n* Community - dwelling men aged 65 years and above\n* Total testosterone ≤12.0 nmol/L or calculated free T≤0.25nmol/L\n\nExclusion Criteria:\n\n* Carcinoma of prostate\n* Carcinoma of breast\n* PSA \\>4ng/mL\n* Severe symptomatic benign prostatic hypertrophy (IPSS \\>21)\n* Active liver disease\n* Renal impairment (serum creatinine \\>180 mmol/L)\n* Congestive heart failure\n* Unstable ischaemic heart disease\n* Polycythaemia\n* Evidence of systemic disease which may affect muscle/joint function\n* Moderate to severe peripheral vascular disease\n* Moderate to severe chronic obstructive airways disease\n* Alcohol consumption over 30 units per week\n* Medications that interfere with sex steroid metabolism\n* History of stroke causing persistent motor deficit\n* Cognitive deficit\n* Major psychiatric illness\n* Hospital admission in the past 6 weeks\n* Sleep apnoea"}, 'identificationModule': {'nctId': 'NCT00190060', 'briefTitle': 'Study of The Effects of Testosterone in Frail Elderly Men', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Manchester University NHS Foundation Trust'}, 'officialTitle': 'Study of The Effects of Testosterone on Muscle Function, Physical Performance, Body Composition and Quality of Life in Frail Elderly Men', 'orgStudyIdInfo': {'id': 'CMMCHUT PIN 9197'}, 'secondaryIdInfos': [{'id': 'T0053/WTCRF'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Transdermal testosterone gel (Testogel 1% )', 'interventionNames': ['Drug: Transdermal testosterone gel (Testogel 1% )']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Matched transdermal placebo gel', 'interventionNames': ['Drug: Matched transdermal placebo gel']}], 'interventions': [{'name': 'Transdermal testosterone gel (Testogel 1% )', 'type': 'DRUG', 'otherNames': ['Testogel 1%'], 'description': 'Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months', 'armGroupLabels': ['1']}, {'name': 'Matched transdermal placebo gel', 'type': 'DRUG', 'description': 'Matched transdermal placebo gel, 50mg/d for 6 months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Professor Frederick CW Wu, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Central Manchester and Manchester Children's University Hospitals Trust & The University of Manchester"}, {'name': 'Dr Martin Connolly, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Central Manchester and Manchester Children's University Hospitals Trust"}, {'name': 'Professor JA Oldham, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Manchester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Manchester', 'class': 'OTHER'}, {'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}