The introduction of a transdermal hormonal contraceptive (Ortho Evra™/Evra™)

Abstract

Unintended pregnancy continues to be a major public health issue in the United States. Of the approximately 6 million pregnancies that occur each year, almost half are considered unintended, and approximately 1.2 million of these are terminated in elective abortion (1Henshaw S.K. Unintended pregnancy in the United States.Fam Plann Perspect. 1998; 30: 24-29, 46Crossref PubMed Scopus (1072) Google Scholar). Of note, most unintended pregnancies occur in women who are using some form of contraception. Although the combination estrogen-progestin pill is the most widely used reversible contraceptive method in the United States, it is estimated that approximately 1 million unintended pregnancies are related to combination oral contraceptive use, including method failure, inconsistent or incorrect use, or discontinuation without substituting another effective method (2Rosenberg M.J. Waugh M.S. Long S. Unintended pregnancies and use, misuse and discontinuation of oral contraceptives.J Reprod Med. 1995; 40: 355-360PubMed Google Scholar). Combination oral contraceptives were introduced into the United States more than 40 years ago. Since then, focus has been placed on developing phasic dosing regimens and newer pill formulations with lower doses of estrogen and various progestins, aimed to improve the tolerability of combination oral contraceptives. Until recently, no alternative combination hormonal products were available to women other than combination oral contraceptives. However, recent developments include delivery systems that are more convenient to the user, with the hope of decreasing contraceptive failures associated with incorrect use. New options include the combination estrogen-progestin monthly injectable (Lunelle™), the levonorgestrel intrauterine system (Mirena®), the combination estrogen-progestin vaginal ring (NuvaRing®), and a combination estrogen-progestin transdermal contraceptive (Ortho Evra™; Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey). The newest contraceptive option available in the United States is the once-weekly transdermal patch. One advantage of the patch is its once-weekly dosing schedule, which has been found to improve compliance compared with a combination oral contraceptive regimen requiring daily pill taking (3Audet M.C. Moreau M. Koltun W.D. Waldbaum A.S. Shangold G. Fisher A.C. et al.Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive a randomized controlled trial.JAMA. 2001; 285: 2347-2354Crossref PubMed Scopus (304) Google Scholar). Unlike implants or intrauterine systems, the transdermal contraceptive patch and the vaginal ring are user controlled and easy to discontinue, making them an appealing option to many women. Of note, however, the patch has a higher failure rate in patients with a body weight >90 kg (4Zieman M. Guillebaud J. Weisberg E. Shangold G. Fisher A. Creasy G. Integrated summary of contraceptive efficacy with the Ortho Evra™/Evra™ transdermal system.Fertil Steril. 2001; 76 ([abstract]): S19Abstract Full Text Full Text PDF Google Scholar, 5Zieman M. Guillebaud J. Weisberg E. Shangold G.A. Fisher A.C. Creasy G.W. Contraceptive efficacy and cycle control with the Ortho Evra™/Evra™ transdermal system the analysis of pooled data.Fertil Steril. 2002; 77: S13-S18Abstract Full Text Full Text PDF PubMed Google Scholar). The association between body weight and the efficacy of various contraceptives, including the patch, combination oral contraceptives, and other hormonal contraceptives, merits further study. With the introduction of any new contraceptive method, it is important to characterize core measures of clinical performance, such as efficacy, cycle control, and tolerability, and when possible, to compare performance to an established and well-accepted method. The efficacy, cycle control, and tolerability of the contraceptive patch have been compared with those of established oral contraceptives in phase II and phase III clinical trials. Furthermore, the patch differs from oral contraceptives in terms of the pharmacokinetics of estrogen and progestin delivery, its unique weekly dosing regimen, and the need for reliable skin adhesion in diverse lifestyle conditions. The purpose of this supplement is to summarize clinical data from numerous trials of the contraceptive patch to address issues of interest to both clinicians and their patients, including the pharmacokinetic profile, efficacy, effects on cycle control, compliance with the weekly dosing regimen, adhesion profile, tolerability, and effect on body weight.