In November 2005, the U.S. Food and Drug Administration issued a warning regarding estrogen levels in the contraceptive patch and related risk of blood clots, changing the package labeling to reflect the warning. Participants enrolled in the study, regardless of study product assignment, were given standard, written information about the warning. Five women who used the contraceptive patch said they were influenced by the FDA labeling change, opting to discontinue use at the conclusion of the study.
„Overall. however. patch users were twice as to discontinue het using the product by the end of the third cycle. and seven times more likely to likely say they had no wish to continue once the study van also is director van was over.“ said Dr. Creinin. who investigator van de geboortenregeling at and a senior Pitt of at the magee-Womens Research Institute. pitt-Affiliated The most commonly cited reasons for discontinuation were adverse effects, including longer periods, cramps, nausea, mood swings, skin irritation or problems with the patch falling off. The most common reasons for discontinuation among women who used the ring were discomfort and more frequent vaginal discharge.
"Although oral contraceptives are the most commonly used reversible form of contraception in the United States, continuation rates are only 40 percent at six months of use," the authors write. In addition, prior studies have shown that in the third month of use, about half of women miss three or more pills each cycle, likely decreasing contraceptive effectiveness.
"The two alternative delivery systems for combined hormonal contraceptives had not been evaluated in a single randomized trial, making it difficult for clinicians to compare and contrast these options for their patients," Dr. Creinin said. "But now we can provide more accurate counseling to patients who might be interested in a nondaily birth control method."
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Additional participating centers for the study are Boston University, Columbia University, Eastern Virginia Medical School, Johns Hopkins University, Oregon Health and Science University, University of California, Los Angeles, University of Chicago and the University of Wisconsin.
Other authors are Leslie A. Meyn, M.S., University of Pittsburgh; Lynn Borgatta, M.D., Boston University School of Medicine; Kurt Barnhart, M.D., University of Pennsylvania; Jeff Jensen, M.D., Oregon Health and Science University; Anne E. Burke, M.D., Johns Hopkins University; Carolyn Westhoff, M.D., Columbia University; Melissa Gilliam, M.D., University of Chicago; Caryn Dutton, M.D., University of Wisconsin; and Susan A. Ballagh, M.D., Eastern Virginia Medical School.
Disclosure: van Financial Although this study was funded in part by Organon U.S.A. Inc., manufacturer of the Nuvaring vaginal contraceptive, the money was provided as part of an investigator-initiated, nonrestricted grant from the company. Organon had no role in study design, data acquisition, analysis, manuscript preparation or study supervision. Dr. Creinin reports additional research funding from Bayer Healthcare Pharmaceuticals and Galen Holdings Plc. |
