Sports doping MedDRA version: 16.1 Level: LLT Classification code 10043364 Term: Testosterone System Organ Class: 100000004848
Conditions
Interventions
Trade Name: testex elmu prolongatum 250 mg
Pharmaceutical Form: Injection
INN or Proposed INN: TESTOSTERONE CIPIONATE
CAS Number: 58-20-8
Other descriptive name: TESTOSTERONE CIPIONATE
Concentration u
Sponsors
Cristina Fernandez Pérez
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: healthy athletes aged 18 to 50 years 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: men with prostate or breast carcinoma pregnant or lactating women athletes in treatments with drugs contraindicated according to summary product. Athletes submitted to doping test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Contrast variability of steroid profile during at least periods of time of two months versus the model developed from 2 days based model. Follow development of mathematical model implemented to characterized steroid profile during long periods of time.;Secondary Objective: Characterize modification of steroid profile when testosterone is administered. Develop an analytical method that based on the use of GC-MS/MS permits to decrease uncertainty for quantification of samples with low concentration. Determine the parameters of the steroid profile taht will be more stables and sensitive against the exogenous administration fo steroids of endogenous steroids. Study the genetic influence over the steroid profile when an administration take place. Evaluate the efficiency of the CIRMS analysis for the selected population, influence of the genetic factor. Compare the efficiency of CIRMS analysis and the mathematical model. Identify new metabolites that could be less affected for the deletion.;Primary end point(s): Urine concentration of testosterone, epitestosterone, androsterone, etiocholanolone, dihydrotestosterone, dehydroepiandrosterone;Timepoint(s) of evaluation of this end point: DAYs: 1, 11, 21, 31, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 56, 61, 66, 71, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 91, 96, 101, 106, 111, 121, 131, 141, 161, 171. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Study group, age, gender, impact of competition, date with time of collection of the urine sample, training hours day / week, hematological parameters of overtraining. Blood tests: hemoglobin, red blood cells, hematocrit, mean corpuscular volume, HCM, HCMC, reticulocytes, leukocytes, leukocyte distribution, platelets, platelet distribution, urea, creatinine, liver enzymes, CPK and blood testosterone cortisol ratio, SHBG;Timepoint(s) of evaluation of this end point: DAYs: 1, 11, 21, 31, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 56, 61, 66, 71, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 91, 96, 101, 106, 111, 121, 131, 141, 161, 171. | — |
Countries
Spain
Contacts
Public ContactUCICEC
fundacion para la investigación biomedica del hospital clínico San Carlos
Outcome results
None listed