Administration of Hydrocortisone in Young Healthy Male Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Administration of Hydrocortisone in Young Healthy Male Volunteers: Determination of Biomarkers for Distinguishing Between Local and Systemic Pathways

Conditions
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Anti-doping Campaign, Detection of Hydrocortisone

Intervention / Treatment
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* Drug: Hydrocortisone administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male subjects aged 18 to 30 years 18 < BMI < 28 participating in regular physical activity (3-5 times/week) subjects not on medication 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Monocentric, randomized, open-label study Distribution of patients in groups according to a ratio (1:1)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical hydrocortisone administration<br>dermal cream (twice a day, 2.5 g of cream, 1% hydrocortisone during 5 days) | Drug: Hydrocortisone administration<br>* Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments<br>|
| Active Comparator: Systemic hydrocortisone administration<br>tablets (once a day, 50 mg, morning, during 50 days) | Drug: Hydrocortisone administration<br>* Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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, | 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 | 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 | Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood concentration of cortisol | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days | 
| blood concentration of cortisol | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; | Day 12 | 
| blood concentration of DeHydroEpiAndrostérone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days | 
| blood concentration of DeHydroEpiAndrostérone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; | 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 | 7 days | 
| blood concentration of Adreno CorticoTrophic Hormone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; | Day 12 | 
| saliva concentration of cortisol | Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days | 
| saliva concentration of DeHydroEpiAndrostérone | Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm | 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 | 7 days | 
| saliva concentration of cortisol | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am | Day 12 | 
| saliva concentration of Adreno CorticoTrophic Hormone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am | Day 12 | 
| saliva concentration of DeHydroEpiAndrostérone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am | Day 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrocortisone (cortisol), local administration of cortisol, systemic administration of cortisol, biomarkers