Administration of Hydrocortisone in Young Healthy Male Volunteers

NCT04137302 | Completed Phase 4

• 1 other identifier: CHRO 2019-04
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Anti-doping Campaign, Detection of Hydrocortisone

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry

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

  7 days

• Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry

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

  Day 12

• Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t

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

  7 days

• Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t

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

  Day 12

Secondary Outcomes (12)

• blood concentration of cortisol

  7 days

• blood concentration of cortisol

  Day 12

• blood concentration of DeHydroEpiAndrostérone

  7 days

• blood concentration of DeHydroEpiAndrostérone

  day 12

• blood concentration of Adreno CorticoTrophic Hormone

  7 days

Study Arms (2)

Topical hydrocortisone administration

ACTIVE COMPARATOR

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

Drug: Hydrocortisone administration

Systemic hydrocortisone administration

ACTIVE COMPARATOR

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

Drug: Hydrocortisone administration

Interventions

Hydrocortisone administration 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; Topical hydrocortisone administration

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male subjects
• aged 18 to 30 years
• \< BMI \< 28
• participating in regular physical activity (3-5 times/week)
• subjects not on medication

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Regional Hospital Center of ORLEANS

Orléans, 45067, France

Location

Related Publications (4)

• 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.

  PMID: 17805102 BACKGROUND

• 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.

  PMID: 19056411 BACKGROUND

• 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.

  PMID: 27643452 BACKGROUND

• 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.

  PMID: 18048433 BACKGROUND

Study Officials

• AMIOT Virgile, MD

  Hospital Regional Center of ORLEANS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, randomized, open-label study Distribution of patients in groups according to a ratio (1:1)

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: November 13, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)