Achieving Extended Amenorrhea with the Contraceptive Patch
Abstract & Commentary
By Frank W. Ling, MD, Clinical Professor, Department of Obstetrics and Gynecology, Vanderbilt University School of Medicine, Nashville, TN, is Associate Editor for OB/GYN Clinical Alert
Dr. Ling reports no financial relationships to this field of study.
Synopsis: Extended patch use effectively reduced bleeding days when compared with cyclic use.
Source: Stewart FH, et al. Extended Use of Transdermal Norelgestromin/Ethinyl Estradiol: A Randomized Trial. Obstet Gynecol. 2005;105:1389-1396.
Healthy, regularly menstruating subjects received either 12 consecutive active patches followed by patch-free week, then 3 more weeks of patches or 4 consecutive cycles of standard patch therapy, which includes 3 patches, then 1 patch-free week. Of the 239 patients initially randomized, 191 completed the study. Bleeding and satisfaction data were collected. The extended patch use was associated with fewer median bleeding days (6 vs 14), bleeding episodes (1 vs 3), spotting episodes (2 vs 3) as well as a longer median time to first bleeding (54 vs 25 days). The median number of spotting days was similar between the groups (14 vs 16), and, although not statistically significant, there were slightly more adverse events associated with extended use. Both regimens were found to be highly satisfactory to the subjects.
Stewart and colleagues conclude that, because the extended use of the patch delayed menses and was associated with fewer bleeding days, this may represent a useful alternative for some patients who wish to experience fewer periods.
Commentary
As the youth of America say: "Duh!" This monosyllabic response is commonly forthcoming when the intuitively obvious has been uttered. In this case, the seasoned clinician can point to previous experience with the extended use of birth control pills as the template. In fact, this very publication (and this very columnist) wrote about extended use oral contraceptives in 2003. So why state the obvious? I’m glad you asked.
First of all, for many physicians, someone else needs to be the first to show that an off-label use of a medication or a novel therapeutic approach works in order for them to use it. There’s certainly nothing inherently wrong with that approach to clinical medicine. By being neither the first nor the last, the practitioner remains safely in the mainstream of practice. An article such as this provides the reassurance that their patients can now benefit from this new approach.
Second, this study opens doors to even greater flexibility in patch use. The study required the patients to use 12 consecutive weeks of active patch. Given the patient satisfaction, one can imagine, then, that patients could choose to use either fewer consecutive patches, or even more as they adjust patch use/menstrual cycle control relative to their social calendars or other personal priorities.
Third, use of contraception can sometimes create a ripple effect. This occurs both at a patient level as well as a provider level. If a single patient uses the patch in an extended fashion, it is likely that she will tell others who either use the patch or another form of contraception. This affects not only how other patients use the patch, but also impacts the decision-making and clinical practice of other practitioners whose patients may come in asking about what "my friend is doing."
Fourth, an article such as this sometimes serves as an "Aha!" moment in clinical medicine. What is an "Aha!" moment? It occurs when a proverbial light bulb suddenly comes on and illuminates a passageway or corner that was previously dimly or poorly lit. In this case, knowing that extended use of the patch may be used, the physician who is faced with patients who are experiencing side effects or problems with the patch can inquire how the patient is using the patch. I know it’s hard to believe, but some patients actually do not use medication exactly as instructed by their physician! (note the sarcasm). So patients may well be asked how they are using the patch as a routine question when problems arise just as pill users are monitored to make sure that they are compliant.
Fifth, it is important to acknowledge subtle findings that are not statistically significant but bear watching. Patients on extended patch use reported more headache, nausea, and breast discomfort than their cyclic-use counterparts. Stewart et al suggest an estrogenic effect in some women. These side effects may/may not be even more problematic if patients and their patients choose to extend patch use beyond 12 weeks. It is also possible that use beyond 12 weeks may result in different overall findings.
Just as Seasonale has created more attention for extended use oral contraceptives, this article opens the door to other novel applications of the contraceptive patch. Each of us in our own practice certainly would like access to as many viable therapeutic options as possible. This was another one.
Healthy, regularly menstruating subjects received either 12 consecutive active patches followed by patch-free week, then 3 more weeks of patches or 4 consecutive cycles of standard patch therapy, which includes 3 patches, then 1 patch-free week.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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