Contraceptive Patch as Safe and Effective as Pill

May 8, 2001 -- The world's first contraceptive patch — nowawaiting U.S. government approval — is as safe and effective as thepill, and easier to remember to use, research suggests.

A study on the patch appears in Wednesday's Journal of theAmerican Medical Association and was included in the manufacturer'sapplication for Food and Drug Administration approval in December.The manufacturer paid for the study.

The government review of the patch, made by Johnson & Johnson'sOrtho-McNeil Pharmaceutical Inc., is expected to take a year. Thecompany also has applied for approval in Europe.

No Bigger Than a Matchbook

The adhesive hormone patch is about the size of a matchbook. Itdelivers continuous low levels of estrogen and progestin, designed,like birth control pills, to prevent ovulation. It can be worn onthe abdomen or buttocks.

Three patches, each worn for a week, are used during an average woman's 28-day menstrualcycle. The user has her period in the fourth week.

The study suggests the Ortho Evra patch will offer "the promiseof another safe and effective form of reversible contraception,"said Dr. Paul Blumenthal, a Johns Hopkins University researcher andmedical adviser to Planned Parenthood who was not involved in theresearch.

The study compared results from 812 women wearing the patchvs. 605 on Wyeth-Ayerst's Triphasil birth control pills for atleast six cycles.

Five patch women got pregnant, compared with seven on the pill.But the difference was not considered statistically significant.

Once a Week Proved to Benefit

The percentage of cycles in which there was perfect compliance,meaning the method was used as directed, was nearly 90 percent inthe patch women and nearly 80 percent in the pill women.

"The numerically lower overall failure rate for thecontraceptive patch may be due to better compliance shown with thisonce-weekly dosing regimen," the researchers wrote.

Twenty percent of the patch users had skin irritations at thepatch site. Other side effects were relatively common in bothgroups and were mostly minor, such as headaches, nausea and breastdiscomfort.

The price of the patch has not been determined.