Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT00161304
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C004648', 'term': 'testosterone enanthate'}, {'id': 'D013739', 'term': 'Testosterone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Men With Low Testosterone Levels']}, 'referencesModule': {'references': [{'pmid': '17105798', 'type': 'DERIVED', 'citation': 'Marks LS, Mazer NA, Mostaghel E, Hess DL, Dorey FJ, Epstein JI, Veltri RW, Makarov DV, Partin AW, Bostwick DG, Macairan ML, Nelson PS. Effect of testosterone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2351-61. doi: 10.1001/jama.296.19.2351.'}], 'seeAlsoLinks': [{'url': 'http://www.usrf.org', 'label': 'Urological Sciences Research Foundation'}]}, 'descriptionModule': {'briefSummary': 'The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.', 'detailedDescription': 'The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels. The primary objectives of the study are to measure the changes in tissue hormones and other biomarkers in the prostate tissue specimens.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The screening evaluation consisted of:\n\n1. medical history, which included the androgen deficiency of the aging male questionnaire\n2. physical examination\n3. multiphasic serum panel\n4. measurement of total serum testosterone and PSA levels\n\nExclusion criteria included:\n\n1. use in the past 6 months of any drug potentially affecting the pituitary-gonadal axis\n2. serum PSA level greater than 10.0 ng/mL\n3. refusal or inability to undergo prostate biopsies\n4. presence of prostate cancer on initial biopsy results.'}, 'identificationModule': {'nctId': 'NCT00161304', 'briefTitle': 'Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'Urological Sciences Research Foundation'}, 'officialTitle': 'Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men)', 'orgStudyIdInfo': {'id': 'T-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Testosterone Enanthate', 'description': 'Testosterone', 'interventionNames': ['Drug: Testosterone Enanthate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Testosterone Enanthate', 'type': 'DRUG', 'otherNames': ['testosterone'], 'description': 'Testosterone Enanthate', 'armGroupLabels': ['Testosterone Enanthate']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90232', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'Urological Sciences Research Foundation', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}], 'overallOfficials': [{'name': 'Leonard S Marks, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urological Sciences Research Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leonard S. Marks, M.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}, {'name': 'Watson Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Leonard S. Marks, M.D.', 'investigatorAffiliation': 'Urological Sciences Research Foundation'}}}}