Implications of different application sites on the bioavailability of a transdermal contraceptive patch containing ethinyl estradiol and gestodene: an open-label, randomized, crossover study

Abstract

Differences in systemic EE/GSD exposure following patch application to the outer, upper arm vs. lower abdomen and buttocks are unlikely to be clinically relevant, and there were no relevant safety concerns.

Pharmacokinetics and adhesion of a transdermal patch containing ethinyl estradiol and gestodene under conditions of heat, humidity, and exercise: A single‐center, open‐label, randomized, crossover study

“…Data from another study (n = 43) investigating the relative bioavailability of ethinyl estradiol and gestodene after application of the ethinyl estradiol/gestodene patch to the abdomen demonstrated pharmacokinetic results similar to those reported here . In the aforementioned study, the geometric mean AUC 0–168 for ethinyl estradiol and gestodene was 4,235 ng · h/L and 771 μg · h/L, respectively, compared with the corresponding geometric mean values of 4,595 ng · h/L and 834 μg · h/L for SNA in this study .…”

“…Data from another study (n = 43) investigating the relative bioavailability of ethinyl estradiol and gestodene after application of the ethinyl estradiol/gestodene patch to the abdomen demonstrated pharmacokinetic results similar to those reported here . In the aforementioned study, the geometric mean AUC 0–168 for ethinyl estradiol and gestodene was 4,235 ng · h/L and 771 μg · h/L, respectively, compared with the corresponding geometric mean values of 4,595 ng · h/L and 834 μg · h/L for SNA in this study . A study of the pharmacokinetics of an oral contraceptive containing 0.075 mg gestodene and 0.02 mg ethinyl estradiol showed that AUC 0–24 and C max for ethinyl estradiol increased by 40%–60% from single‐treatment values of 612 and 65 ng/L, respectively, during treatment cycles .…”

“…Ethinyl estradiol and gestodene are well absorbed through the skin and are, therefore, appropriate for transdermal contraceptive delivery. 3,13,14 Ethinyl estradiol is the most potent estrogen agonist available, and its use in COCs is well documented. 15 Gestodene is a wellresearched progestin with established efficacy and safety and has been widely used as a contraceptive in Europe for more than 20 years.…”

“…Ethinyl estradiol and gestodene are well absorbed through the skin and are, therefore, appropriate for transdermal contraceptive delivery . Ethinyl estradiol is the most potent estrogen agonist available, and its use in COCs is well documented .…”