H-CORT: Administration of Hydrocortisone in Young Healthy Male Volunteers

• Sponsor: Centre Hospitalier Régional d'Orléans (Other)
• Overall Status: Completed
• CT.gov ID: NCT04137302
• Collaborator: French Anti-Doping Agency (AFLD) (Other), University Hospital, Tours (Other)
• Enrollment: 21
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 8.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anti-doping Campaign, Detection of Hydrocortisone	Drug: Hydrocortisone administration	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Monocentric, randomized, open-label study Distribution of patients in groups according to a ratio (1:1)Monocentric, randomized, open-label study Distribution of patients in groups according to a ratio (1:1)
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Administration of Hydrocortisone in Young Healthy Male Volunteers: Determination of Biomarkers for Distinguishing Between Local and Systemic Pathways
• Actual Study Start Date: Nov 13, 2019
• Actual Primary Completion Date: Jan 31, 2020
• Actual Study Completion Date: Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Topical hydrocortisone administration dermal cream (twice a day, 2.5 g of cream, 1% hydrocortisone during 5 days)	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
Active Comparator: Systemic hydrocortisone administration tablets (once a day, 50 mg, morning, during 50 days)	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

Outcome Measures

Primary Outcome Measures

1. Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry [7 days]

   Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm

2. 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,

3. Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t [7 days]

   Isotope ratio mass spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm

4. 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

1. blood concentration of cortisol [7 days]

   Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm

2. blood concentration of cortisol [Day 12]

   Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;

3. blood concentration of DeHydroEpiAndrostérone [7 days]

   Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm

4. blood concentration of DeHydroEpiAndrostérone [day 12]

   Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;

5. blood concentration of Adreno CorticoTrophic Hormone [7 days]

   Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm

6. blood concentration of Adreno CorticoTrophic Hormone [Day 12]

   Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;

7. saliva concentration of cortisol [7 days]

   Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm

8. saliva concentration of DeHydroEpiAndrostérone [7 days]

   Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm

9. saliva concentration of Adreno CorticoTrophic Hormone [7 days]

   Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm

10. saliva concentration of cortisol [Day 12]

    Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am

11. saliva concentration of Adreno CorticoTrophic Hormone [Day 12]

    Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am

12. saliva concentration of DeHydroEpiAndrostérone [Day 12]

    Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regional Hospital Center of ORLEANS	Orleans		France	45067

Sponsors and Collaborators

• Centre Hospitalier Régional d'Orléans
• French Anti-Doping Agency (AFLD)
• University Hospital, Tours

Investigators

• Study Director: AMIOT Virgile, MD, Hospital Regional Center of ORLEANS

Study Documents (Full-Text)

None provided.

More Information

Publications

• Arlettaz A, Portier H, Lecoq AM, Rieth N, De Ceaurriz J, Collomp K. Effects of short-term prednisolone intake during submaximal exercise. Med Sci Sports Exerc. 2007 Sep;39(9):1672-8.
• Buisson C, Mongongu C, Frelat C, Jean-Baptiste M, de Ceaurriz J. Isotope ratio mass spectrometry analysis of the oxidation products of the main and minor metabolites of hydrocortisone and cortisone for antidoping controls. Steroids. 2009 Mar;74(3):393-7. doi: 10.1016/j.steroids.2008.11.001. Epub 2008 Nov 13.
• Collomp K, Arlettaz A, Buisson C, Lecoq AM, Mongongu C. Glucocorticoid administration in athletes: Performance, metabolism and detection. Steroids. 2016 Nov;115:193-202. doi: 10.1016/j.steroids.2016.09.008. Epub 2016 Sep 16. Review.
• Collomp K, Arlettaz A, Portier H, Lecoq AM, Le Panse B, Rieth N, De Ceaurriz J. Short-term glucocorticoid intake combined with intense training on performance and hormonal responses. Br J Sports Med. 2008 Dec;42(12):983-8. Epub 2007 Nov 29.

• Responsible Party: Centre Hospitalier Régional d'Orléans
• ClinicalTrials.gov Identifier: NCT04137302
• Other Study ID Numbers: CHRO 2019-04
• First Posted: Oct 24, 2019
• Last Update Posted: Dec 7, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Régional d'Orléans: Hydrocortisone (cortisol); local administration of cortisol; systemic administration of cortisol; biomarkers
• Additional relevant MeSH terms: Hydrocortisone

Study Results

No Results Posted as of Dec 7, 2020