Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): Testosterone gel; Ethanol Solution; Testosterone placebo (vaseline); Ethanol placebo (lemon-flavoured water)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Testogel 50 mg®; Vodka Absolut®; Vaselina Pura Pege®; Lemon flavored-water Fontvella®
Intervention MeSH terms: Ethanol; Methyltestosterone; Petrolatum; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects receive 4 different treatment conditions (testosterone+ethanol placebo, ethanol+testosterone placebo, testosterone+ethanol, and placebo testosterone+placebo ethanol), separated by a wash-out period of 15 days. The order of the treatment conditions is randomly assigned.
Masking: Single (Participant)
Primary purpose: Other
Keywords: Testosterone; Ethanol; Anti-doping control; Athletic performance