Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-01 @ 12:32 PM
Study NCT ID:
NCT00504712
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2007-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testosterone for Peripheral Vascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '01226 431684', 'title': 'Professor TH Jones', 'organization': 'Barnsley Hospital NHS Foundation Trust'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'It was more difficult than anticipated to recruit patients to the trial and despite extension of the trial beyond expected completion date the target recruitment was not achieved.'}}, 'adverseEventsModule': {'description': 'Specific Adverse Event terms were not used for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Active', 'description': 'Testosterone 200 mg intramuscular every 2 weeks\n\nTestosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks', 'otherNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 11, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Saline\n\nsaline: Saline injection every two weeks', 'otherNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Adverse Event', 'notes': 'viral illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Adverse', 'notes': 'chest infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Adverse', 'notes': 'post injection muscle haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Adverse', 'notes': 'fracture of humerus,', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Adverse', 'notes': 'unilateral calf swelling with no DVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'adverse', 'notes': 'viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Adverse', 'notes': 'gynaecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Serious', 'notes': 'Admitted with chest pain and shortness of breath.\n\nDiagnosis was obstructive sleep apnoea and exacerbation of known heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Serious', 'notes': 'Admitted with worsening foot ulceration, heart failure and acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Adverse Event', 'notes': 'Diagnosed bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Arterial Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'Testosterone 200 mg intramuscular every 2 weeks\n\nTestosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Saline\n\nsaline: Saline injection every two weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '15.02', 'spread': '5.74', 'groupId': 'OG000'}, {'value': '15.08', 'spread': '6.59', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '14.08', 'spread': '5.36', 'groupId': 'OG000'}, {'value': '16.12', 'spread': '7.42', 'groupId': 'OG001'}]}]}, {'title': '26 weeks', 'categories': [{'measurements': [{'value': '14.01', 'spread': '4.53', 'groupId': 'OG000'}, {'value': '12.58', 'spread': '5.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 26 weeks', 'description': 'The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist.', 'unitOfMeasure': 'index β', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in IMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'Testosterone 200 mg intramuscular every 2 weeks\n\nTestosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Saline\n\nsaline: Saline injection every two weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.856', 'spread': '0.132', 'groupId': 'OG000'}, {'value': '0.885', 'spread': '0.130', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '0.843', 'spread': '0.137', 'groupId': 'OG000'}, {'value': '0.887', 'spread': '0.120', 'groupId': 'OG001'}]}]}, {'title': '26 weeks', 'categories': [{'measurements': [{'value': '0.841', 'spread': '0.135', 'groupId': 'OG000'}, {'value': '0.872', 'spread': '0.124', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 26 weeks', 'description': 'Progression of Carotid intima-media thickness measured in mm', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active', 'description': 'Testosterone 200 mg intramuscular every 2 weeks\n\nTestosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Saline\n\nsaline: Saline injection every two weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'started 02/02/2006'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active', 'description': 'Testosterone 200 mg intramuscular every 2 weeks\n\nTestosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Saline\n\nsaline: Saline injection every two weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.6', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '61.7', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '59.15', 'spread': '11.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participants were men aged greater than 40 years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2007-07-19', 'resultsFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2007-07-19', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-03', 'studyFirstPostDateStruct': {'date': '2007-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Arterial Stiffness', 'timeFrame': 'Baseline, 12 weeks, and 26 weeks', 'description': 'The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist.'}], 'secondaryOutcomes': [{'measure': 'Change in IMT', 'timeFrame': 'Baseline, 12 weeks, and 26 weeks', 'description': 'Progression of Carotid intima-media thickness measured in mm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Testosterone', 'Hypogonadism', 'Diabetes', 'PVD', 'RCT'], 'conditions': ['Hypogonadism', 'Peripheral Vascular Disease', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.', 'detailedDescription': 'Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Type 2 diabetes mellitus.\n2. Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism.\n3. Peripheral vascular disease as defined by\n\n * previous diagnosis by a specialist vascular surgeon OR\n * ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene).\n4. Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.\n5. Ability to give written informed consent after verbal and written explanation in the English language.\n6. Ability to comply with all study requirements.\n\nExclusion Criteria:\n\n1. Current or previous breast cancer.\n2. Current or previous prostate cancer.\n3. Raised prostate specific antigen (PSA) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion.\n4. Severe symptoms of benign prostatic hypertrophy ('prostatism')\n5. Treatment with testosterone in the 3 months prior to the trial.\n6. Investigational drug treatment in the 3 months prior to the trial."}, 'identificationModule': {'nctId': 'NCT00504712', 'briefTitle': 'Testosterone for Peripheral Vascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Barnsley Hospital'}, 'officialTitle': 'A Randomised, Double Blind, Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Treatment on Peripheral Vascular Disease in Hypogonadal Men With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Testosterone 200 mg intramuscular every 2 weeks', 'interventionNames': ['Drug: Testosterone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline', 'interventionNames': ['Drug: saline']}], 'interventions': [{'name': 'Testosterone', 'type': 'DRUG', 'description': 'Sustanon- 200mg- Intramuscular testosterone every 2 weeks', 'armGroupLabels': ['Active']}, {'name': 'saline', 'type': 'DRUG', 'description': 'Saline injection every two weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S75 2EP', 'city': 'Barnsley', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Barnsley Hospital NHS Foundation Trust', 'geoPoint': {'lat': 53.55, 'lon': -1.48333}}], 'overallOfficials': [{'name': 'Thomas H Jones', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barnsley Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barnsley Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}