A New Option for Contraception — The Patch
August 1, 2001 2 minutes read
A New Option for Contraception—The Patch
Abstract & commentary
Synopsis: The contraceptive patch was found comparable to oral contraception in efficacy and cycle control.
Source: Audet MC, et al. JAMA. 2001;285:2347-2354.
Audet and colleagues reported the results from a multicenter trial studying a transdermal contraceptive patch. This trial included 1417 women who were randomized to either the contraceptive patch or an oral contraceptive (Triphasil®), and followed for either 6 cycles or 13 cycles. Although the differences were not statistically significant, the failure rate was lower in the patch group than in the oral contraceptive group. Only 5 pregnancies occurred with the patch (1 user failure and 4 method failures). The breakthrough bleeding incidence and pattern were similar in the 2 groups. Spotting was slightly higher in the first 2 cycles with the patch. Perfect compliance with the patch was achieved in 88.7% of the cycles compared with 79.2% in the oral contraceptive cycles. Also, 4.6% of the patches had to be replaced for either partial or complete detachment. Breast discomfort was slightly higher in the first 2 cycles with the patch. Dysmenorrhea was also more frequent with the patch, but the difference did not achieve statistical significance. The contraceptive patch, therefore, was comparable to oral contraception in efficacy and cycle control.
COMMENT BY LEON SPEROFF, MD
The contraceptive patch is expected to be on the US market in the summer of 2001 from Ortho-McNeil, with the trade name "Ortho Evra®." The 20 cm2 patch delivers 20 mg ethinyl estradiol and 150 mg norelgestromin (the active metabolite of norgestimate) daily. Each patch provides effective systemic blood levels of the steroid hormones for a little more than 7 days; therefore, treatment consists of a new patch applied weekly for 3 weeks followed by a patch-free week. The patch can be applied to the buttocks, the upper outer arm, the lower abdomen, or upper torso (except for the breasts). The patch has been studied under rigorous conditions (exercising, swimming, and in sauna baths), and patients can be reassured that usual activities need not be limited.
Although the cycle control data indicated that breakthrough bleeding and spotting were similar with the 2 methods studied, note that the oral contraceptive was Triphasil®, a product that delivers more estrogen per day than the patch. Thus, this patch that delivers 20 mg ethinyl estradiol per day performed better than what we would expect with a 20 mg oral product.
The most obvious advantage for this contraceptive patch is the improvement in compliance with the once-a-week administration. The better failure rate with the patch in this study did not achieve statistical significance, but the difference promises to be an important one when the product is in general use, most likely due to better compliance. Although the patch won’t be acceptable for all women—2.6% of the participants in this study withdrew because of application site reactions—the option should be presented to any patient considering oral contraception. The potential for greater efficacy because of better compliance makes the patch a good choice for all women, and especially teenagers.
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