Pharmacokinetics of Norelgestromin and Ethinyl Estradiol from Two Consecutive Contraceptive Patches

Abstract

The primary objective of this open-label study was to determine the pharmacokinetics of norelgestromin (NGMN) and ethinyl estradiol (EE)following two consecutive applications of a contraceptive patch (ORTHO EVRA/EVRA). Twelve healthy women wore the first patch on their abdomen for 7 days and, after removal at 168 hours (day 7), wore a second patch for 10 days (i.e., 3 days beyond the intended 7-day wear period). Blood samples were collected before and at various times up to 456 hours (day 19) after application of the first patch for analysis of NGMN and EE. Mean serum concentrations of NGMN and EE remained within the reference ranges, 0.6 to 1.2 ng/ml and 25 to 75 pg/ml, respectively, during the entire 7-day wear period after application of the first patch and for 10 days after application of the second patch; reference ranges are based on studies with ORTHO-CYCLEN/ Cilest. No patch detached spontaneously. No subject discontinued or experienced a serious adverse event.

Pharmacokinetics of a contraceptive patch (Evra™/Ortho Evra™) containing norelgestromin and ethinyloestradiol at four application sites

“…The results demonstrated that mean serum concentrations of NGMN and EE remained within the reference ranges (0.6–1.2 ng ml −1 and 25–75 pg ml −1 , respectively) during the 7 day wear period, regardless of whether the patch was worn on the abdomen, buttock, arm, or torso. These findings confirm and extend those of previous studies in which serum concentrations of NGMN and EE remained in the reference ranges during patch application to the abdomen [11–13] or buttock [12]. Absorption of NGMN and EE was approximately 20% less and not strictly bioequivalent when the patch was worn on the abdomen compared with the other three sites.…”

Pharmacokinetics of Norelgestromin and Ethinyl Estradiol Delivered by a Contraceptive Patch (Ortho Evra™/Evra™) under Conditions of Heat, Humidity, and Exercise

“…Previous studies have reported the pharmacokinetic profile of NGMN and EE during 7 days of use [10][11][12] or over multiple cycles 13,14 of Ortho Evra™ wear. Evaluating a contraceptive patch under various conditions of heat and humidity is critical to ensure that pharmacokinetics and/or patch adhesion is not significantly altered in a manner that could reduce contraceptive protection.…”

IVG précoce à domicile et contraception immédiate post-IVG par le patch Evra®

“…Les risques vasculaires sont identiques pour les estroprogestatifs oraux de première, deuxième et troisième génération [6] et une seule étude [7] a montré des risques équivalents pour patch et pilule (OP). À la différence des composés administrés par voie orale, le patch Evra ® obtient des taux plasmatiques stables d'éthinylestradiol et de progestatif (norelgestromine), conformes aux valeurs de référence, sans pic de concentration et sans à-coup [8]. Une étude montre aussi que ces taux sériques se maintiennent dans la zone de réfé-rence (d'après les concentrations moyennes observées en contraception orale) jusqu'à neuf jours d'application du patch [6] : une simulation d'oubli de changement du patch au bout d'une semaine montre ainsi une efficacité contraceptive durant deux jours supplémentaires.…”