Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT01616732
Status:
COMPLETED
Last Update Posted:
2016-06-06
First Post:
2012-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testosterone and Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-03', 'studyFirstSubmitDate': '2012-06-08', 'studyFirstSubmitQcDate': '2012-06-11', 'lastUpdatePostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity in Men']}, 'referencesModule': {'references': [{'pmid': '33864607', 'type': 'DERIVED', 'citation': 'Grossmann M, Fui MNT, Nie T, Hoermann R, Clarke MV, Cheung AS, Zajac JD, Davey RA. Changes in white adipose tissue gene expression in a randomized control trial of dieting obese men with lowered serum testosterone alone or in combination with testosterone treatment. Endocrine. 2021 Aug;73(2):463-471. doi: 10.1007/s12020-021-02722-0. Epub 2021 Apr 17.'}, {'pmid': '27716209', 'type': 'DERIVED', 'citation': 'Ng Tang Fui M, Prendergast LA, Dupuis P, Raval M, Strauss BJ, Zajac JD, Grossmann M. Effects of testosterone treatment on body fat and lean mass in obese men on a hypocaloric diet: a randomised controlled trial. BMC Med. 2016 Oct 7;14(1):153. doi: 10.1186/s12916-016-0700-9.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesise that testosterone therapy will synergize with dietary intervention to achieve weight loss. Obese men will receive diet, and be randomised to either testosterone therapy or placebo. Primary outcomes will be weight and body composition.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>30\n\nExclusion Criteria:\n\n* contraindications to testosterone therapy'}, 'identificationModule': {'nctId': 'NCT01616732', 'briefTitle': 'Testosterone and Weight Loss', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Austin Health'}, 'officialTitle': 'Effect of Testosterone and Diet on Weight', 'orgStudyIdInfo': {'id': '04495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'testosterone', 'description': 'against placebo', 'interventionNames': ['Drug: Testosterone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Testosterone', 'type': 'DRUG', 'description': 'TU im', 'armGroupLabels': ['testosterone']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo im', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Austin Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mathis Grossmann', 'investigatorAffiliation': 'Austin Health'}}}}