Pharmacokinetics, tolerability and cycle control of three transdermal contraceptive delivery systems containing different doses of ethinylestradiol and levonorgestrel

Abstract

AbstractThe only available contraceptive patch, Ortho EvraThree transdermal contraceptive delivery systems (TCDS) containing low doses of ethinylestradiol (EE) and levonorgestrel (LNG) were evaluated in two open-label randomized trials. In a phase 1, two-period, cross-over trial, AG200-12.5 and AG200LE were compared with a 150 μg LNG/30 μg EE oral contraceptive (OC) (LevlenIn Study 1, mean steady-state plasma concentrations (All three patches exhibited excellent safety and wearability profiles while maintaining plasma drug levels required for ovulation suppression and adequate cycle control. A slight increase in the EE dose in AG200-15 still places this TCDS within the range of low-dose OCs, with EE exposure much lower than reported for Ortho Evra. AG200-15 was selected for further testing in phase 3 studies.