A newer version of contraceptive patch is testing as safe and as effective as traditional birth control pills, in a nationwide study led by a University of Florida College of Medicine-Jacksonville professor.
About 1,500 women have been involved in the study led by Andrew M. Kaunitz, M.D., professor and associate chair of obstetrics and gynecology. Kaunitz presented the findings in May at the annual meeting of the American College of Obstetricians and Gynecologists in San Diego.
The patch could receive Food and Drug Administration approval by the end of the year, which could put it on the market in another year, Kaunitz said.
More than 90 health centers across the nation are involved in a clinical trial for what Kaunitz refers to as a "second generation" birth control patch. A first version of the patch was released in 2002 and was met with great demand among women. Problems arose when it was discovered the estrogen dosage was high and appeared to lead to a higher risk of blood clots, pulmonary embolism and other serious health problems than oral contraceptives.
Yet the concept is still attractive to many women for the same reasons the initial patch was so popular, Kaunitz said.
"There are a lot of women who would rather not have to worry about birth control every day with a pill," Kaunitz said.
The patch in this new trial, AG200-15 developed by Agile Therapeutics, has about half of the estrogen dosage as the original patch. In the study, funded by Agile Therapeutics, women were monitored for 13 menstrual cycles. The majority (1,128) were given the patch for the duration, while the remaining 375 received an oral contraceptive for six cycles before switching to the patch.
Blood draws were taken three times during the study, along with physical and pelvic examinations at the start of the trial, the midway point and two weeks after the last patch was removed.
The patch is most commonly applied to the abdomen or buttocks and needs to be replaced weekly. A small percentage of women reported skin irritation, but 80 percent said they did not have any problems. When doctors or nurses observed the patches during office visits, more than 99 percent of the patches adhered well to the participant’s skin and less than 3 percent of women reported adhesion issues in their patient journals.
Nine of the women in the study were UF College of Medicine-Jacksonville participants, and none had any serious complications, Kaunitz said.
The trial also found that, contrary to previous thinking, the patch worked just as well with women who were overweight or obese, which Kaunitz said was a pleasant surprise.
Kaunitz has had a focused interest in contraception, and much of his research has centered on that area.
After graduating from medical school at the Columbia College of Physicians and Surgeons in New York City, Kaunitz completed his residency at Northwestern University and subsequently spent two years as an epidemic intelligence officer with the Centers for Disease Control studying contraception and other reproductive issues before coming to the UF College of Medicine-Jacksonville in 1984.