Characterization and Detection of Prolonged Endothelin Receptors Antagonists Administration
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
Endothelin receptors antagonists (ERA), such as bosentan and ambrisentan, are a class of
vasoactive drugs that have been developed for the treatment of pulmonary arterial
hypertension. It has been anecdotally reported that ERA is frequently used among top-level
athletes to counteract exercise-induced rise in pulmonary vascular pressures and increase
exercise performance. Yet, the effects of ERA on exercise capacity in healthy humans are
puzzling, with the drugs not included in the current Prohibited List, since the ergogenic
potential is yet to be fully understood and determined. Furthermore, the urinary excretion of
ERA metabolites following administration has not been studied systematically at rest and
during exercise in athletes, as a way to detect its intake if performance-enhancing potential
is confirmed. In the planned study ERA will be administered in newly approved doses for 8
weeks in order to assess the presumed doping potential for both male and female athletes, and
to monitor serum and urinary ERA excretion dynamics after single- and multiple-dose
administration. The possible effects of prolonged ERA administration in higher doses on
exercise performance may be relevant, if further confirmed, in terms of their possible
fraudulent utilization to influence exercise performance in sports, raising the difficult
question of whether, particularly in some circumstances, the ERA might be considered as
prohibited substances in athletes.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Center for Health, Exercise and Sport Sciences, Serbia