Administration of Hydrocortisone in Young Healthy Male Volunteers

Centre Hospitalier Régional d'Orléans21 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Anti-doping Campaign, Detection of Hydrocortisone

Interventions

Hydrocortisone administrationDRUG

Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments

Eligibility

Sex: MALEMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Regional Hospital Center of ORLEANS

Orléans, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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