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Administration of Hydrocortisone in Young Healthy Male Volunteers (H-CORT)

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ClinicalTrials.gov Identifier: NCT04137302
Recruitment Status : Recruiting
First Posted : October 24, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborators:
French Anti-Doping Agency (AFLD)
University Hospital, Tours
Information provided by (Responsible Party):
Centre Hospitalier Régional d'Orléans

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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)

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 : November 13, 2019
Estimated Primary Completion Date : July 13, 2021
Estimated Study Completion Date : July 13, 2021


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




Primary Outcome Measures :
  1. Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 12 ]
    Isotope ratio mass spectrometry to study biomarkers urine level at 8 am


Secondary Outcome Measures :
  1. blood concentration of cortisol [ Time Frame: 7 days ]
    Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm

  2. blood concentration of cortisol [ Time Frame: Day 12 ]
    Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;

  3. blood concentration of DeHydroEpiAndrostérone [ Time Frame: 7 days ]
    Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm

  4. blood concentration of DeHydroEpiAndrostérone [ Time Frame: day 12 ]
    Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;

  5. blood concentration of Adreno CorticoTrophic Hormone [ Time Frame: 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 [ Time Frame: Day 12 ]
    Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;

  7. saliva concentration of cortisol [ Time Frame: 7 days ]
    Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm

  8. saliva concentration of DeHydroEpiAndrostérone [ Time Frame: 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 [ Time Frame: 7 days ]
    Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm

  10. saliva concentration of cortisol [ Time Frame: Day 12 ]
    Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am

  11. saliva concentration of Adreno CorticoTrophic Hormone [ Time Frame: Day 12 ]
    Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am

  12. saliva concentration of DeHydroEpiAndrostérone [ Time Frame: Day 12 ]
    Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137302


Contacts
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Contact: DESPUJOLS Aurélie 33238744071 aurelie.despujols@chr-orleans.fr
Contact: BUISSON Corinne, PhD 33146602869 c.buisson@afld.fr

Locations
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France
Regional Hospital Center of ORLEANS Recruiting
Orleans, France, 45067
Contact: Virgile AMIOT, MD         
Principal Investigator: Virgile AMIOT, MD         
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
French Anti-Doping Agency (AFLD)
University Hospital, Tours
Investigators
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Study Director: AMIOT Virgile, MD Hospital Regional Center of ORLEANS

Publications:
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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT04137302    
Other Study ID Numbers: CHRO 2019-04
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents