Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption
Status:
Completed
Trial end date:
2019-09-26
Target enrollment:
Participant gender:
Summary
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.