DETECTION OF CONSUMPTION OF TESTOSTERONE GEL IN SPORT.

Establishment of an Athlete's Internal Metabolic Reference Using an Isotopic Signature or Isotopic Fingerprint of ?13C Values - testgel

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001655-23-ES

Enrollment

Unknown

Registered

2015-01-12

Start date

2015-05-27

Completion date

Unknown

Last updated

2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SPORT DOPING MedDRA version: 17.1 Level: LLT Classification code 10059568 Term: Urine dihydrotestosterone System Organ Class: 100000004848

Interventions

Trade Name: testim gel Pharmaceutical Form: Gel INN or Proposed INN: TESTOSTERONE CAS Number: SUB10937MIG Current Sponsor code: SUB10937MIG Other descriptive name: SUB10937MIG Concentration unit: mg/g

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. Reduce costs in the current methodology. 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	—

Measure

Time frame

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. Reduce costs in the current methodology. 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

Measure	Time frame
Secondary end point(s): Concentration for: epitestosterone, androsterone, etiocholanolone 5-androstenediol, 5-androstenediol. 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	—

Measure

Time frame

Secondary end point(s): Concentration for: epitestosterone, androsterone, etiocholanolone 5-androstenediol, 5-androstenediol. 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

—

Countries

Spain

Contacts

Public ContactAgencia Española de proteccion de l

Agencia Española de proteccion de la salud en el deporte

rodrigo.aguilera@aepsad.gob.es349154198299829

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026