Status:
COMPLETED
Administration of Hydrocortisone in Young Healthy Male Volunteers
Lead Sponsor:
Centre Hospitalier Régional d'Orléans
Collaborating Sponsors:
French Anti-Doping Agency (AFLD)
University Hospital, Tours
Conditions:
Anti-doping Campaign, Detection of Hydrocortisone
Eligibility:
MALE
18-30 years
Phase:
PHASE4
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...
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...
Eligibility Criteria
Inclusion
- male subjects
- aged 18 to 30 years
- 18 \< BMI \< 28
- participating in regular physical activity (3-5 times/week)
- subjects not on medication
Exclusion
- 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
Key Trial Info
Start Date :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04137302
Start Date
November 13 2019
End Date
January 31 2020
Last Update
December 7 2020
Active Locations (1)
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1
Regional Hospital Center of ORLEANS
Orléans, France, 45067