Background: Testosterone is an anabolic steroid widely known to improve physical performance. Its consumption is banned by the World Anti-Doping Agency (WADA). The steroid profile is one of the components of the Athlete's Biological Passport (ABP), which consists of selected biological variables that indirectly reveal the effects of doping. Alcohol consumption has been proved to alter the steroid profile and this may lead to the use of ethanol as a masking agent for testosterone administration. Hypothesis: Ratios of different testosterone biomarkers vary after ethanol administration: \[6-hydroxy-androsterone-3-glucuronide (6OH-Andros3G) / epitestosterone-glucuronide (EG)\] and \[6-hydroxy-etiocholanolone-3-glucuronide (6OH-Etio3G) / EG\] decrease, while \[testosterone-glucuronide (TG) / EG\] increases. Primary objective: To evaluate if the combination of the markers TG, EG, 6OH-Andros3G and 6OH-Etio3G, as well as ethyl glucuronide (EtG) and ethyl sulfate (EtS), can be routinely used to differentiate between changes in the steroid profile due exclusively to the consumption of alcohol and those produced when alcohol is consumed during a testosterone administration. Secondary objectives: 1. To explore the potential of the simultaneous determination of both phase I and phase II metabolites in alternative matrices (plasma from blood samples collected as for the haematological module of ABP, or saliva) in the screening of testosterone misuse. 2. To look for the differences into a comprehensive steroid profile (determined in urine, plasma and saliva) between samples collected after testosterone administration and after the combination of testosterone and ethanol. Methods: Phase I, single-blind, crossover-design clinical trial, placebo controlled, with 4 conditions randomly assigned in male healthy caucasian subjects with a wash-out period between treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
4
Subjects receive a daily transdermal dose of 100 mg of testosterone (2 sachets of 5 g of gel) during 3 days.
Subjects receive a daily administration of 30 g of ethanol (94 mL of Vodka Absolut® diluted in 300 mL of lemon-flavoured water Fontvella®) during 3 days.
Subjects receive a daily transdermal dose of 5 g of pure vaseline ointment during 3 days.
Subjects receive a daily administration of 394 mL of lemon-flavored-water Fontvella® during 3 days.
IMIM (Hospital del Mar Medical Research Institute)
Barcelona, Spain
Change in steroid profile in urine
Variation of the concentration of different endogenous steroids (testosterone, epitestosterone, androsterone, etiocholanolone, 3a,5a-androstanediol, 3a,5b-androstanediol, DHEAS, 5PTS, 5PDS, PTG, PDG) in urine before and after treatment administration.
Time frame: From baseline (pre-administration) to 48 hours after last administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24 hours each day, and 24-48 hours post-administration last day)
Change in new steroid profile markers in plasma
Variation of the concentration of new steroid profile markers (6OH-Andros3G, 6OH-Etio3G, testosterone free TG, Andros, Andros3G, Etio, Etio3G) in plasma before and after treatment administration.
Time frame: From baseline (pre-administration) to 8 hours post-administration (at 0, 2, 4, 6, 8 hours each day)
Change in new steroid profile markers in saliva
Variation of the concentration of new steroid profile markers (6OH-Andros3G, 6OH-Etio3G, testosterone free TG, Andros, Andros3G, Etio, Etio3G) in saliva before and after treatment administration.
Time frame: From baseline (pre-administration) to 8 hours post-administration (at 0, 2, 4, 6, 8 hours each day)
Change in Ethyl glucuronide in urine
Variation of the concentration of Ethyl glucuronide in urine before and after treatment administration.
Time frame: From baseline (pre-administration) to 48 hours post-administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24, 24-48 hours)
Change in Ethyl sulfate in urine
Variation of the concentration of Ethyl sulfate in urine before and after treatment administration.
Time frame: From baseline (pre-administration) to 48 hours post-administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24, 24-48 hours)
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