Monitoring of endogenous steroids in female serum

Code: R20M01MS

Primarily, the objective of this project is to conduct an exploratory study to monitor the blood steroid profile of women subjects over two menstrual cycles to compare the intra- and inter-individual variability of the blood steroid profile of women subjects during a menstrual cycle. Secondly, transdermal testosterone gel (Androgel 1%, AbbVie, North Chicago, IL) will be administered to all volunteers once. The study will enable the pharmacokinetic study of transdermal testosterone gel in women in addition to its detection and will allow to determine putative differences of steroid metabolism between men and women. Simultaneously, the urinary steroid profile will be monitored to allow comparison of the steroid profile between both matrices. This study should help to develop further the blood steroidal of the ABP and to refine the identification of doping behaviours in females with adequate investigations allowing to define reference values for specific female athletic populations. This study will also allow to lay the foundations for a further untargeted metabolomics project for the discovery of new steroidomic biomarkers for steroid detection in female athletes. The design of the study was modified and extended to three menstrual cycles and the treatment regimen was modified. Instead of a single application, testosterone gel (Tostran 20mg/g, 0.5g applied corresponding to 10mg of testosterone) is applied daily for a menstrual cycle (corresponding to 28 days).

Main Findings

In women, hormonal fluctuations related to menstrual cycle may impose a great source of variability for some urinary biomarkers of testosterone (T) administration, which can ultimately disrupt the sensitivity of their longitudinal monitoring. Additional biomarkers and alternative matrices need therefore to be investigated to improve the detection capability for doping practices with T, especially in female athletes. The aim of this study was therefore to investigate the impact of menstrual cycle combined with T gel administration on the biomarkers of the ABP (steroidal and haematological module) and on serum steroid biomarkers in females. It allowed to directly compare the sensitivity of T gel detection between urinary and blood steroid profiling either for targeting samples for IRMS or for longitudinal evaluation. To achieve this, a clinical trial involving fourteen healthy women subjects was conducted over three consecutive menstrual cycles with the second cycle combined with a daily administration of T gel for 28 days. The sensitivity of the current urinary and haematological markers of the Athlete Biological Passport (ABP), as well as serum steroid biomarkers was investigated for the monitoring of the T gel treatment. Additionally, endogenous fluctuation of these parameters were monitored within the menstrual cycle.