Evaluation of Contraceptive Efficacy and Cycle Control of 
a Transdermal Contraceptive Patch vs an Oral Contraceptive  

A Randomized Controlled Trial 

Journal of the American Medical Association v.285, n.18 9may01

Note that this paper only refers to the contraceptive ability and not to the health effects due to low-dose toxicity that could take years to show its effects. There very well could be many harmful effects on the health of future generations because of the use of this hormone patch by women today.

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

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.

JAMA. 2001;285:2347-2354

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Author/Article Information
 
 
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.
 
Corresponding Author and Reprints: George W. Creasy, MD, The R. W. Johnson Pharmaceutical Research Institute, 920 Route 202, PO Box 300, Raritan, NJ 08869 (e-mail: gcreasy@prius.jnj.com).

Author Contributions: Dr Audet, as principal investigator, verifies that she had full access to the data in the study and takes full responsibility for the integrity of data collection and the accuracy of data analysis.

Study concept and design: Shangold, Creasy.

Acquisition of data: Audet, Moreau, Waldbaum, Koltun.

Analysis and interpretation of data: Shangold, Fisher, Creasy.

Drafting of the manuscript: Fisher, Creasy.

Critical revision of the manuscript for important intellectual content: Audet, Moreau, Waldbaum, Koltun, Shangold, Fisher, Creasy.

Statistical expertise: Fisher.

Administrative, technical, or material support: Shangold, Creasy, Fisher.

Study supervision: Audet, Moreau, Waldbaum, Koltun, Shangold, Creasy.

Principal Investigators for the ORTHO EVRA/EVRA 004 Study Group: C. Bouchard, B. D. Peskin, T. S. Kosasa, M. V. Farmer, J. M. Ruiz III, R. M. Hampton, F. M. Fisk, R. S. Boroditsky, I. D. Dattani, D. L. Gearhart, P. McLeod, S. C. Bowman, M. D. Creinin, R. K. Bath, R. S. Corwin, K. S. Pitts, J. Maher, K. K. Fry, P. J. Lane, S. Rosenblatt, M. Skesas, R. L. Parker Jr, P. A. Stephenson, M. A. Heuer, J. E. Pappas, C. A. Ayers, S. Dunn, J. B. Rosen, R. H. Friedman, K. Posey, M. Zieman, M. S. Hanson, E. Kirschman, R. A. Nordland, W. L. Harper, S. G. Osbourne, and B. S. May.

Data Support: M. E. Hill, C. Javick, N. Hall, J. Honnegar, and J. Roach.

Editorial Assistance: M. S. McNamara.

Funding/Support: This work was supported by The R. W. Johnson Pharmaceutical Research Institute, Raritan, NJ.

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