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

Centre Hospitalier Régional d'Orléans

Status and phase: Completed; Phase 4

Conditions: Anti-doping Campaign, Detection of Hydrocortisone

Treatments: Drug: Hydrocortisone administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04137302

CHRO 2019-04

Details and patient eligibility

About

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.

Full 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)

Enrollment: 21 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Topical hydrocortisone administration

Active Comparator group

Description:

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

Treatment:

Drug: Hydrocortisone administration

Systemic hydrocortisone administration

Active Comparator group

Description:

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

Treatment:

Drug: Hydrocortisone administration