NCT04166786

Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption

Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption: Evaluation of Newly Developed Markers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Testosterone gel	Subjects receive a daily transdermal dose of 100 mg of testosterone (2 sachets of 5 g of gel) during 3 days.
DRUG	Ethanol Solution	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.
DRUG	Testosterone placebo (vaseline)	Subjects receive a daily transdermal dose of 5 g of pure vaseline ointment during 3 days.
DRUG	Ethanol placebo (lemon-flavoured water)	Subjects receive a daily administration of 394 mL of lemon-flavored-water Fontvella® during 3 days.

Timeline

• Start date: 2019-05-06
• Primary completion: 2019-09-26
• Completion: 2019-09-26
• First posted: 2019-11-18
• Last updated: 2019-11-18

Locations

1 site across 1 country: Spain