Androgen metabolism and doping tests
Phase 1
- Conditions
- Healthy volunteers will be studied regarding androgen metabolism and doping tests.Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2007-002655-16-SE
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Healthy and normal laboratory test results
18-50 years of age
Signed informed consent
Meeting the right genotype
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Disease or abnormal laboratory test results
NSAID use
Member of a Sport Federation
Malignancy within the last 5 years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Is it possible to improve doping tests employed today;Secondary Objective: Is it possible to improve the T/E test by using differentiated cut-off values for different genotypes?<br>Will a combined genetic test and urine analysis improve the detection rate for nandrolone?<br>Is it possible that NSAIDs and analgesic may mask abuse of testosterone by alteration of its disposition?<br>To study interindividual variation in Nandrolone disposition;Primary end point(s): Genetic variability in androgen disposition - implications in doping;Timepoint(s) of evaluation of this end point: within six months after injection
- Secondary Outcome Measures
Name Time Method Secondary end point(s): genetic variations in kinetics;Timepoint(s) of evaluation of this end point: within six months after injection