DETECTION OF CONSUMPTION OF TESTOSTERONE GEL IN SPORT.

Phase 1

Conditions: SPORT DOPING
MedDRA version: 17.1Level: LLTClassification code 10059568Term: Urine dihydrotestosteroneSystem Organ Class: 100000004848
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2014-001655-23-ES

Lead Sponsor: Rodrigo Aguilera

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Not to be taking or having taken doping products.
- Not to be susceptible to doping control
- Age between 18-40 years.
- Women without contraceptives or pregnant prior pregnancy test done.
- Diseases that may be affected by the scheduled administration.
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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

To have taken doping products in the past year.
Athletes susceptible to doping control
Women whor are taking contraceptives, or who are pregnant.
Pathologies that may be affected by the scheduled administration.
Hypertension, metabolic disorders (hyperlipidemia), endocrine disorders (diabetes, hypothyroidism, adrenal gland disorders), acne, psychiatric disorders, genitourinary disordres.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine urinary parameters which are most effective to implement an analytical method to detect the application of testosterone gel;Secondary Objective: To increase interlaboratory homegenidad.<br> Reduce costs in the current methodology.<br> Implement the isotopic fingerprint as an element of longitudinal follow-up.;Primary end point(s): Testosterone concentration;Timepoint(s) of evaluation of this end point: one per month during the first year, every day during drug and placebo administration, one per week during washout period

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Concentration for: epitestosterone, androsterone, etiocholanolone 5-androstenediol, 5-androstenediol.<br> 13C content: Testosterone, epitestosterone, androsterone, etiocholanolone 5-androstenediol, 5-androstenediol and pregnandiol.;Timepoint(s) of evaluation of this end point: one per month during the first year, every day during drug and placebo administration, one per week during washout period