Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 5:15 AM
Study NCT ID:
NCT00740194
Status:
COMPLETED
Last Update Posted:
2011-08-30
First Post:
2008-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D047072', 'term': 'Aromatase Inhibitors'}, {'id': 'D004958', 'term': 'Estradiol'}], 'ancestors': [{'id': 'D065088', 'term': 'Steroid Synthesis Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004965', 'term': 'Estrogen Antagonists'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-29', 'studyFirstSubmitDate': '2008-08-21', 'studyFirstSubmitQcDate': '2008-08-21', 'lastUpdatePostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of sex steroids on adipocytes', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'Effects of sex steroids on lipid metabolism', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physiology', 'males'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website of the University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'Aromatase inhibition versus estradiol during 1 week'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent obtained.\n* Male subjects\n* Age 18 - 40\n* weight \\< 120 kg\n\nExclusion Criteria:\n\n* Primary hypogonadism or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.\n* Treatment with insulin, corticoids, opiates (on a daily basis), androgen- or estrogen analogs or CYP2A6 substrates (Dexmedetomidine, Ifosfamide, Methoxsalen, Miconazole, Tranylcypromine).\n* Impaired renal function defined as serum-creatine \\> 1.5 mg/dL\n* Impaired liver function, defined as ALAT \\> 2.5 times upper limit of normal\n* Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III or IV) at the discretion of the investigator\n* Cancer or any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial\n* Palpable prostate nodule or induration, PSA \\> 3 ng/mL, prostatism, untreated sleep apnee syndrome, erythrocytosis (hematocrit \\> 50%) or hyperviscosity.\n* Known or suspected abuse of alcohol or narcotics\n* Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation."}, 'identificationModule': {'nctId': 'NCT00740194', 'briefTitle': 'Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men.', 'orgStudyIdInfo': {'id': '2007/279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Aromatase inhibition', 'interventionNames': ['Drug: Aromatase inhibition']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Estradiol', 'interventionNames': ['Drug: Estradiol']}], 'interventions': [{'name': 'Aromatase inhibition', 'type': 'DRUG', 'description': 'Letrozole', 'armGroupLabels': ['1']}, {'name': 'Estradiol', 'type': 'DRUG', 'description': 'Dermestril', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Johannes Ruige, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}