Administration of Hydrocortisone in Young Healthy Male Volunteers: Determination of Biomarkers for Distinguishing Between Local and Systemic Pathways
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male subjects
- •aged 18 to 30 years
- •18 < BMI < 28
- •participating in regular physical activity (3-5 times/week)
- •subjects not on medication
排除标准
- •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
研究组 & 干预措施
Topical hydrocortisone administration
dermal cream (twice a day, 2.5 g of cream, 1% hydrocortisone during 5 days)
干预措施: Hydrocortisone administration (Drug)
Systemic hydrocortisone administration
tablets (once a day, 50 mg, morning, during 50 days)
干预措施: Hydrocortisone administration (Drug)
结局指标
主要结局
Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry
时间窗: Day 12
Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am,
Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t
时间窗: Day 12
Isotope ratio mass spectrometry to study biomarkers urine level at 8 am
次要结局
- blood concentration of cortisol(Day 12)
- saliva concentration of cortisol(Day 12)
- blood concentration of Adreno CorticoTrophic Hormone(Day 12)
- saliva concentration of DeHydroEpiAndrostérone(Day 12)
- blood concentration of DeHydroEpiAndrostérone(day 12)
- saliva concentration of Adreno CorticoTrophic Hormone(Day 12)