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Evaluation of Contraceptive Efficacy and Cycle Control of a Transdermal Contraceptive Patch vs an Oral Contraceptive
A Randomized Controlled Trial
Marie-Claude Audet, MD;
Michèle Moreau, MD;
William D. Koltun, MD;
Arthur S. Waldbaum, MD;
Gary Shangold, MD;
Alan C. Fisher, DrPH;
George W. Creasy, MD;
for the ORTHO EVRA/EVRA 004 Study Group
JAMA. 2001;285:2347-2354.
Context Oral contraceptive (OC) pills are effective, but poor compliance increases rates of pregnancy during treatment.
Objective To compare the contraceptive efficacy, cycle control, compliance, and safety of a transdermal contraceptive patch and an OC.
Design Randomized, open-label, parallel-group trial conducted October 1997 to June 1999.
Setting Forty-five clinics in the United States and Canada.
Participants A total of 1417 healthy adult women of child-bearing potential.
Interventions 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.
Main Outcome Measures 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.
Results 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 cycles in the patch group, but the incidence of breakthrough bleeding alone was comparable between treatments in all cycles. The mean proportion of participants' cycles with perfect compliance was 88.2% (811 total participants, 5141 total cycles) with the patch and 77.7% (605 total participants, 4134 total cycles) with the OC (P < .001). Only 1.8% (300/16 673) of patches completely detached. Both treatments were similarly well tolerated; however, application site reactions, breast discomfort, and dysmenorrhea were significantly more common in the patch group.
Conclusion The contraceptive patch is comparable to a combination OC in contraceptive efficacy and cycle control. Compliance was better with the weekly contraceptive patch than with the OC.
Author Affiliations: Centre Médical des Halles de Ste-Foy, Ste-Foy, Quebec (Dr Audet); Departement d'obstetrique-gynecologie, Centre Hospitalier de l'Université de Montréal, Montréal, Quebec (Dr Moreau); Medical Center for Women's Clinical Research, San Diego, Calif (Dr Koltun); Department of Clinical Research, The R. W. Johnson Pharmaceutical Research Institute, Raritan, NJ (Drs Shangold, Fisher, and Creasy). Dr Waldbaum is in private practice in Denver, Colo.
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