A Phase 4 interventional study of Hydrocortisone administration in Anti-doping Campaign, Detection of Hydrocortisone, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 1 site in France. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-07.
Sponsored by Centre Hospitalier Régional d'Orléans · Phase 4, Interventional, and Other
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.
The 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.
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)
Centre Hospitalier Régional d'Orléans is the lead sponsor of 129 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
male subjects
Exclusion Criteria:
asthmatic 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
dermal cream (twice a day, 2.5 g of cream, 1% hydrocortisone during 5 days)
Drug: Hydrocortisone administration
tablets (once a day, 50 mg, morning, during 50 days)
Drug: Hydrocortisone administration
Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments
Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry
Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm
Time frame: 7 days
Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry
Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am,
Time frame: Day 12
Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t
Isotope ratio mass spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm
Time frame: 7 days
Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t
Isotope ratio mass spectrometry to study biomarkers urine level at 8 am
Time frame: Day 12
blood concentration of cortisol
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm
Time frame: 7 days
blood concentration of cortisol
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;
Time frame: Day 12
blood concentration of DeHydroEpiAndrostérone
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm
Time frame: 7 days
blood concentration of DeHydroEpiAndrostérone
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;
Time frame: day 12
blood concentration of Adreno CorticoTrophic Hormone
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm
Time frame: 7 days
blood concentration of Adreno CorticoTrophic Hormone
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;
Time frame: Day 12
saliva concentration of cortisol
Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm
Time frame: 7 days
saliva concentration of DeHydroEpiAndrostérone
Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm
Time frame: 7 days
saliva concentration of Adreno CorticoTrophic Hormone
Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm
Time frame: 7 days
saliva concentration of cortisol
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am
Time frame: Day 12
saliva concentration of Adreno CorticoTrophic Hormone
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am
Time frame: Day 12
saliva concentration of DeHydroEpiAndrostérone
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am
Time frame: Day 12
Plan to share: No
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Régional d'Orléans