WESTPORT, CT (Reuters Health) – A new weekly transdermally delivered hormonal contraceptive appears effective and well tolerated, according to a report in the November issue of Obstetrics and Gynecology.
Dr. George W. Creasy from the R. W. Johnson Pharmaceutical Research Institute in Raritan, New Jersey, and colleagues with the Ortho EVRA/EVRA 002 Study Group, conducted an open-label study of the Ortho EVRA/EVRA contraceptive system. The system includes a skin patch that delivers 150 µg norelgestromin and 20 µg ethinyl estradiol daily over 7 days.
The 1672 sexually active women in the study, 18 to 45 years of age, were assigned to Ortho EVRA/EVRA for either six or 13 menstrual cycles in a regimen that comprised 3 weeks of wearing patches followed by 1 patch-free week.
Through 13 cycles the overall probability of pregnancy was 0.7% and method-failure probability was 0.4%, the researchers found. Perfect compliance with the regimen was 90%, and the rate of patch replacement for complete detachment was only 1.9.
Adverse reactions were similar to those found with all hormonal contraceptives, with only mild to moderate reactions to the patch itself, which were typical with topically applied medications, the investigators note. Ten percent or more of the women reported reactions that included headache, application-site reactions, nausea, breast discomfort, upper respiratory infection and dysmenorrhea.
"The contraceptive patch provides combination hormonal contraception with convenient weekly dosing for a 21-day regimen," Dr. Creasy's group states. "The excellent compliance seen with the contraceptive patch in this study and other studies comparing once-weekly dosing with daily oral contraceptive dosing may reflect the convenience of weekly dosing with the patch," they add.
Obset Gynecol 2001;98:799-805.
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