NCT04137302

Administration of Hydrocortisone in Young Healthy Male Volunteers

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: Male
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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)

Conditions

• Anti-doping Campaign, Detection of Hydrocortisone

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-13
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2019-10-24
• Last updated: 2020-12-07

Locations

1 site across 1 country: France