PMID: 11343482May 10, 2001Paper

Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial

JAMA : the Journal of the American Medical Association
M C AudetORTHO EVRA/EVRA 004 Study Group

Abstract

Oral contraceptive (OC) pills are effective, but poor compliance increases rates of pregnancy during treatment. To compare the contraceptive efficacy, cycle control, compliance, and safety of a transdermal contraceptive patch and an OC. Randomized, open-label, parallel-group trial conducted October 1997 to June 1999. Forty-five clinics in the United States and Canada. A total of 1417 healthy adult women of child-bearing potential. Participants were randomly assigned to receive a transdermal contraceptive patch (n = 812) vs an OC (n = 605) for 6 or 13 cycles. Patch treatment consisted of application of 3 consecutive 7-day patches followed by 1 patch-free week. Overall and method-failure Pearl Indexes (number of pregnancies/100 person-years of use) and life-table estimates of the probability of pregnancy were calculated. Cycle control, compliance, patch adhesion, and adverse events were also assessed. Overall and method-failure Pearl Indexes were numerically lower with the patch (1.24 and 0.99, respectively) vs the OC (2.18 and 1.25, respectively); this difference was not statistically significant (P =.57 and.80, respectively). The incidence of breakthrough bleeding and/or spotting was significantly higher only in the first 2 cyc...Continue Reading

Citations

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