NCT04137302: H-CORT

Administration of Hydrocortisone in Young Healthy Male Volunteers

Completed Phase 4 Last updated 7 December 2020

What this trial tests

Phase 4 trial testing Hydrocortisone administration in Anti-doping Campaign, Detection of Hydrocortisone in 21 participants. Completed in 31 January 2020.

Timeline

13 November 2019

Primary endpoint
31 January 2020

31 January 2020

Quick facts

Lead sponsor	Centre Hospitalier Régional d'Orléans
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	21
Start date	13 November 2019
Primary completion	31 January 2020
Estimated completion	31 January 2020
Sites	1 location across France

Drugs / interventions tested

• Hydrocortisone administration — full drug profile →

Conditions studied

• Anti-doping Campaign, Detection of Hydrocortisone — all drugs for Anti-doping Campaign, Detection of Hydrocortisone →

Sponsor

Centre Hospitalier Régional d'Orléans

Who can join

Adults 18 to 30, male only, with Anti-doping Campaign, Detection of Hydrocortisone. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.