Viewing Study NCT04137302



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Study NCT ID: NCT04137302
Status: COMPLETED
Last Update Posted: 2020-12-07
First Post: 2019-10-22

Brief Title: Administration of Hydrocortisone in Young Healthy Male Volunteers
Sponsor: Centre Hospitalier Régional dOrléans
Organization: Centre Hospitalier Régional dOrléans

Study Overview

Official Title: Administration of Hydrocortisone in Young Healthy Male Volunteers Determination of Biomarkers for Distinguishing Between Local and Systemic Pathways
Status: COMPLETED
Status Verified Date: 2020-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: H-CORT
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 ie 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None