Administration of Hydrocortisone in Young Healthy Male Volunteers

Phase 4

Completed

• Conditions: Anti-doping Campaign, Detection of Hydrocortisone
• Interventions: Drug: Hydrocortisone administration

• Registration Number: NCT04137302
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Study Start: 2019-11-13
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical hydrocortisone administration	Hydrocortisone administration	dermal cream (twice a day, 2.5 g of cream, 1% hydrocortisone during 5 days)
Systemic hydrocortisone administration	Hydrocortisone administration	tablets (once a day, 50 mg, morning, during 50 days)

Primary Outcome Measures

Name	Time	Method
Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry	Day 12	Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am,
Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t	Day 12	Isotope ratio mass spectrometry to study biomarkers urine level at 8 am

Secondary Outcome Measures

Name	Time	Method
saliva concentration of DeHydroEpiAndrostérone	Day 12	Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am
blood concentration of cortisol	Day 12	Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;
saliva concentration of cortisol	Day 12	Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am
blood concentration of Adreno CorticoTrophic Hormone	Day 12	Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;
blood concentration of DeHydroEpiAndrostérone	day 12	Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;
saliva concentration of Adreno CorticoTrophic Hormone	Day 12	Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am

Trial Locations

Locations (1)

Regional Hospital Center of ORLEANS; 🇫🇷 Orleans, France