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

Abstract

Aims To determine the pharmacokinetic pro®le of norelgestromin (NGMN) and ethinyloestradiol (EE) following application of the contraceptive patch, Evra TM / Ortho Evra TM , at each of four anatomic sites (abdomen, buttock, arm, and torso). Methods Thirty-seven healthy, nonpregnant women aged 20±45 years participated in this open-label, four-period crossover study. Subjects were randomized to one of four treatment (site of application) sequences. Each patch was worn for 7 days, with a 1 month washout between treatments. Blood samples were collected before and at various times up to 240 h after application of each patch. Serum samples were assayed for NGMN and EE by validated methods. Results The serum concentration reference ranges for NGMN and EE are 0.6±1.2 ng ml x1 and 25±75 pg ml x1 , respectively, based on studies of the mean C ave of oral norgestimate 250 mg and EE 35 mg. For all application sites, mean concentrations of NGMN and EE remained within these ranges during the 7 day wear period. Absorption of NGMN and EE during patch application on the buttock, arm, and torso was equivalent. Absorption of NGMN and EE during patch application on the abdomen was approximately 20% less than observed for the other three sites, although mean serum concentrations were still within reference ranges. A previous study demonstrated therapeutic equivalence of patches worn on the abdomen vs other sites. Conclusions Serum concentrations of NGMN and EE from the contraceptive patch remain within the reference ranges throughout the 7 day wear period, regardless of the site of application (abdomen, buttock, arm, or torso).

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

“…These pharmacokinetic findings are similar to those reported in studies in which Ortho Evra™ was worn under "normal" conditions. [10][11][12][13] In the present study, there were no treatment effects (based on ANOVA) for NGMN. For EE, there was a statistically significant treatment effect (based on ANOVA) for AUC 0-240 h but not for C ss .…”

“…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.…”

Bone Accretion in Adolescents Using the Combined Estrogen and Progestin Transdermal Contraceptive Method Ortho Evra: A Pilot Study

“…Women using this method may maintain their usual activities, including exercise, bathing, swimming, and use of a whirlpool or sauna. [2][3][4][5][6][7][8][9] The fact that Ortho Evra requires attention only once a week compared with the daily attention required with oral contraceptive pills (OCPs) has made this method appealing to adolescents. In studies in the adolescent age group, Ortho Evra provided excellent cycle control, and most adolescents were satisfied with the method.…”

Programmable transdermal drug delivery of nicotine using carbon nanotube membranes

“…Using typical pumping voltages of −0.6 V and 57 μA∕cm 2 , the power consumption of the CNT membrane is also highly favorable for compact devices. For a 25.8 cm 2 (commercially available size) nicotine transdermal patch made of a CNT membrane, a button cell battery with a capacity of 247 mWh can be pumping continuously for 12 d. Several patch products on the market are designed to wear 7 d at a time with acceptable levels of irritation (22).…”