Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT04137302
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2019-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Administration of Hydrocortisone in Young Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Monocentric, randomized, open-label study\n\nDistribution of patients in groups according to a ratio (1:1)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2019-10-22', 'studyFirstSubmitQcDate': '2019-10-22', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry', 'timeFrame': '7 days', 'description': 'Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm'}, {'measure': 'Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry', 'timeFrame': 'Day 12', 'description': 'Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am,'}, {'measure': 'Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t', 'timeFrame': '7 days', 'description': 'Isotope ratio mass spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm'}, {'measure': 'Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t', 'timeFrame': 'Day 12', 'description': 'Isotope ratio mass spectrometry to study biomarkers urine level at 8 am'}], 'secondaryOutcomes': [{'measure': 'blood concentration of cortisol', 'timeFrame': '7 days', 'description': 'Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm'}, {'measure': 'blood concentration of cortisol', 'timeFrame': 'Day 12', 'description': 'Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;'}, {'measure': 'blood concentration of DeHydroEpiAndrostérone', 'timeFrame': '7 days', 'description': 'Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm'}, {'measure': 'blood concentration of DeHydroEpiAndrostérone', 'timeFrame': 'day 12', 'description': 'Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;'}, {'measure': 'blood concentration of Adreno CorticoTrophic Hormone', 'timeFrame': '7 days', 'description': 'Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm'}, {'measure': 'blood concentration of Adreno CorticoTrophic Hormone', 'timeFrame': 'Day 12', 'description': 'Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;'}, {'measure': 'saliva concentration of cortisol', 'timeFrame': '7 days', 'description': 'Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm'}, {'measure': 'saliva concentration of DeHydroEpiAndrostérone', 'timeFrame': '7 days', 'description': 'Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm'}, {'measure': 'saliva concentration of Adreno CorticoTrophic Hormone', 'timeFrame': '7 days', 'description': 'Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm'}, {'measure': 'saliva concentration of cortisol', 'timeFrame': 'Day 12', 'description': 'Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am'}, {'measure': 'saliva concentration of Adreno CorticoTrophic Hormone', 'timeFrame': 'Day 12', 'description': 'Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am'}, {'measure': 'saliva concentration of DeHydroEpiAndrostérone', 'timeFrame': 'Day 12', 'description': 'Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hydrocortisone (cortisol)', 'local administration of cortisol', 'systemic administration of cortisol', 'biomarkers'], 'conditions': ['Anti-doping Campaign, Detection of Hydrocortisone']}, 'referencesModule': {'references': [{'pmid': '17805102', 'type': 'BACKGROUND', 'citation': 'Arlettaz A, Portier H, Lecoq AM, Rieth N, De Ceaurriz J, Collomp K. Effects of short-term prednisolone intake during submaximal exercise. Med Sci Sports Exerc. 2007 Sep;39(9):1672-8. doi: 10.1249/mss.0b013e3180dc992c.'}, {'pmid': '19056411', 'type': 'BACKGROUND', 'citation': 'Buisson C, Mongongu C, Frelat C, Jean-Baptiste M, de Ceaurriz J. Isotope ratio mass spectrometry analysis of the oxidation products of the main and minor metabolites of hydrocortisone and cortisone for antidoping controls. Steroids. 2009 Mar;74(3):393-7. doi: 10.1016/j.steroids.2008.11.001. Epub 2008 Nov 13.'}, {'pmid': '27643452', 'type': 'BACKGROUND', 'citation': 'Collomp K, Arlettaz A, Buisson C, Lecoq AM, Mongongu C. Glucocorticoid administration in athletes: Performance, metabolism and detection. Steroids. 2016 Nov;115:193-202. doi: 10.1016/j.steroids.2016.09.008. Epub 2016 Sep 16.'}, {'pmid': '18048433', 'type': 'BACKGROUND', 'citation': 'Collomp K, Arlettaz A, Portier H, Lecoq AM, Le Panse B, Rieth N, De Ceaurriz J. Short-term glucocorticoid intake combined with intense training on performance and hormonal responses. Br J Sports Med. 2008 Dec;42(12):983-8. doi: 10.1136/bjsm.2007.043083. Epub 2007 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'The misuse of cortisone or hydrocortisone for doping purpose in sport has been widely reported in the literature, but to date, no formal testing procedure is available and applicable in an anti-doping laboratory to detect hydrocortisone doping abuse , i.e., administration by systemic way.\n\nThe investigators therefore propose to identify biomarkers that clearly distinguish between an authorized local administration of hydrocortisone and a prohibited systemic administration, by studying the impact of 5-day administration of hydrocortisone per 2 different routes.', 'detailedDescription': 'Clinical research with two groups of ten volunteers one group with 5 days with local administration (cream, applied to healthy skin) one group with 5 days with systemic route of administration (per os)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male subjects\n\n * aged 18 to 30 years\n * 18 \\< BMI \\< 28\n * participating in regular physical activity (3-5 times/week)\n * subjects not on medication\n\nExclusion Criteria:\n\nasthmatic subjects or history of respiratory or cardiac pathology; use of corticosteroids in the past 6 months; high blood pressure; ulcerated lesions of the skin, acne, rosacea; Infectious state (bacterial, viral, and fungal infections); diabetic subjects; ulcerative history and other gastrointestinal disorders; lactose allergy; galactose intolerance; ulcerative colonic pathology; myastenia gravis; live vaccine kidney failure'}, 'identificationModule': {'nctId': 'NCT04137302', 'acronym': 'H-CORT', 'briefTitle': 'Administration of Hydrocortisone in Young Healthy Male Volunteers', 'organization': {'class': 'OTHER', 'fullName': "Centre Hospitalier Régional d'Orléans"}, 'officialTitle': 'Administration of Hydrocortisone in Young Healthy Male Volunteers: Determination of Biomarkers for Distinguishing Between Local and Systemic Pathways', 'orgStudyIdInfo': {'id': 'CHRO 2019-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Topical hydrocortisone administration', 'description': 'dermal cream (twice a day, 2.5 g of cream, 1% hydrocortisone during 5 days)', 'interventionNames': ['Drug: Hydrocortisone administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Systemic hydrocortisone administration', 'description': 'tablets (once a day, 50 mg, morning, during 50 days)', 'interventionNames': ['Drug: Hydrocortisone administration']}], 'interventions': [{'name': 'Hydrocortisone administration', 'type': 'DRUG', 'description': 'Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments', 'armGroupLabels': ['Systemic hydrocortisone administration', 'Topical hydrocortisone administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': 'Regional Hospital Center of ORLEANS', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}], 'overallOfficials': [{'name': 'AMIOT Virgile, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Regional Center of ORLEANS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Hospitalier Régional d'Orléans", 'class': 'OTHER'}, 'collaborators': [{'name': 'French Anti-Doping Agency (AFLD)', 'class': 'OTHER_GOV'}, {'name': 'University Hospital, Tours', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}