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Administration of Hydrocortisone in Young Healthy Male Volunteers

NCT ID: NCT04137302

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-13

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Anti-doping Campaign, Detection of Hydrocortisone

Keywords

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Hydrocortisone (cortisol) local administration of cortisol systemic administration of cortisol biomarkers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Monocentric, randomized, open-label study

Distribution of patients in groups according to a ratio (1:1)
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Topical hydrocortisone administration

dermal cream (twice a day, 2.5 g of cream, 1% hydrocortisone during 5 days)

Group Type ACTIVE_COMPARATOR

Hydrocortisone administration

Intervention Type DRUG

Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments

Systemic hydrocortisone administration

tablets (once a day, 50 mg, morning, during 50 days)

Group Type ACTIVE_COMPARATOR

Hydrocortisone administration

Intervention Type DRUG

Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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French Anti-Doping Agency (AFLD)

OTHER_GOV

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role collaborator

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AMIOT Virgile, MD

Role: STUDY_DIRECTOR

Hospital Regional Center of ORLEANS

Locations

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Regional Hospital Center of ORLEANS

Orléans, , France

Site Status

Countries

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France

References

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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. doi: 10.1249/mss.0b013e3180dc992c.

Reference Type BACKGROUND
PMID: 17805102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19056411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27643452 (View on PubMed)

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. doi: 10.1136/bjsm.2007.043083. Epub 2007 Nov 29.

Reference Type BACKGROUND
PMID: 18048433 (View on PubMed)

Other Identifiers

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CHRO 2019-04

Identifier Type: -

Identifier Source: org_study_id