Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-30 @ 7:28 PM
Study NCT ID:
NCT00136695
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2005-08-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anastrozole Administration in Elderly Hypogonadal Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bzleder@partners.org', 'phone': '617-726-6723', 'title': 'Dr. Benjamin Leder', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Anastrozole', 'description': 'anastrozole\n\nanastrozole: 1 mg QD', 'otherNumAtRisk': 34, 'otherNumAffected': 3, 'seriousNumAtRisk': 34, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo\n\nanastrozole: 1 mg QD', 'otherNumAtRisk': 35, 'otherNumAffected': 3, 'seriousNumAtRisk': 35, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'PSA increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders'}], 'seriousEvents': [{'term': 'prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'pancreatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Endocrine disorders'}, {'term': 'hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Lean Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anastrozole', 'description': 'anastrozole\n\nanastrozole: 1 mg QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo\n\nanastrozole: 1 mg QD'}], 'classes': [{'categories': [{'measurements': [{'value': '-2000', 'spread': '1000', 'groupId': 'OG000'}, {'value': '-1500', 'spread': '500', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 year', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anastrozole', 'description': 'anastrozole\n\nanastrozole: 1 mg QD'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo\n\nanastrozole: 1 mg QD'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Anastrozole', 'description': 'anastrozole\n\nanastrozole: 1 mg QD'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo\n\nanastrozole: 1 mg QD'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '4', 'groupId': 'BG000'}, {'value': '66', 'spread': '4', 'groupId': 'BG001'}, {'value': '66', 'spread': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2005-08-25', 'resultsFirstSubmitDate': '2016-11-30', 'studyFirstSubmitQcDate': '2005-08-25', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-30', 'studyFirstPostDateStruct': {'date': '2005-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Lean Body Mass', 'timeFrame': 'Baseline and 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aging'], 'conditions': ['Hypogonadism']}, 'referencesModule': {'references': [{'pmid': '15001605', 'type': 'BACKGROUND', 'citation': 'Leder BZ, Rohrer JL, Rubin SD, Gallo J, Longcope C. Effects of aromatase inhibition in elderly men with low or borderline-low serum testosterone levels. J Clin Endocrinol Metab. 2004 Mar;89(3):1174-80. doi: 10.1210/jc.2003-031467.'}, {'pmid': '11397902', 'type': 'BACKGROUND', 'citation': 'Taxel P, Kennedy DG, Fall PM, Willard AK, Clive JM, Raisz LG. The effect of aromatase inhibition on sex steroids, gonadotropins, and markers of bone turnover in older men. J Clin Endocrinol Metab. 2001 Jun;86(6):2869-74. doi: 10.1210/jcem.86.6.7541.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the effects of sustained aromatase inhibitor therapy to reduce estrogen levels in elderly men with mild hypogonadism (a decreased level of sex hormones).', 'detailedDescription': 'It has long been accepted that aging in men is associated with a slow, steady decline in gonadal androgen (male sex hormone) production. Several studies have explored androgen replacement, but the safety and efficacy of testosterone administration remains controversial. Aromatase inhibitors may provide a particularly useful way to restore normal androgen production in aging men.\n\nThis study will recruit 150 male volunteers, 60 years of age or older, to be randomized to receive either anastrozole or a placebo for 24 months. Six visits are planned over the 96-week treatment period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men ages 60 and older\n* Serum testosterone between 150-300 ng/dL\n* Symptoms suggestive of androgen deficiency'}, 'identificationModule': {'nctId': 'NCT00136695', 'briefTitle': 'Anastrozole Administration in Elderly Hypogonadal Men', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Anastrozole Administration in Elderly Hypogonadal Men', 'orgStudyIdInfo': {'id': 'AG0035'}, 'secondaryIdInfos': [{'id': '5R01AG025099-05', 'link': 'https://reporter.nih.gov/quickSearch/5R01AG025099-05', 'type': 'NIH'}, {'id': '1R01AG025099-1A1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anastrozole', 'description': 'anastrozole', 'interventionNames': ['Drug: anastrozole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Drug: anastrozole']}], 'interventions': [{'name': 'anastrozole', 'type': 'DRUG', 'otherNames': ['arimidex'], 'description': '1 mg QD', 'armGroupLabels': ['anastrozole', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'General Clinical Research Center, Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Benjamin Z. Leder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Invesitgator (MD)', 'investigatorFullName': 'Benjamin Leder, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}