Extended use of ring, patch now under review
Extended use of ring, patch now under review
With more women using oral contraceptives (OCs) in extended regimens, scientists are now focusing research on similar applications for the contraceptive vaginal ring (NuvaRing, Organon, West Orange, NJ) and the transdermal contraceptive (Ortho Evra, Ortho-McNeil Pharmaceutical, Raritan, NJ). Results from a randomized trial involving extended use of the patch have just been published, while data from a randomized study comparing extended ring regimens was presented at the May 2005 annual meeting of the American College of Obstetricians and Gynecologists.1,2
Using combined hormonal contraception to delay or prevent withdrawal bleeding is not a new concept. For many years, clinicians have counseled on extending the pill-free interval for women planning a vacation or participating in an athletic event. However, with the November 2003 launch of the first dedicated extended regimen OC (Seasonale, Barr Laboratories, Pomona, NY), clinicians have seen an uptick in interest. About 15% of Contraceptive Technology Update’s 2004 Contraception Survey respondents said they already had incorporated use of Seasonale in their practices.
The contraceptive patch and ring have met with increased acceptance since their 2001 approvals by the Food and Drug Administration (FDA). More than 90% of 2004 CTU survey respondents indicated their facilities were offering or planning to provide the patch last year, while about 70% indicated similar plans for NuvaRing. While researchers are looking at extending the regimens of the two methods, neither Ortho Evra nor NuvaRing have received FDA approval for use outside their standard dosing regimens.
Review the results
In the patch study, investigators compared bleeding profiles and satisfaction among women using the contraceptive patch in an extended regimen to those among women using the traditional 28-day regimen. Women were randomly assigned to a regimen of 12 consecutive weeks, one patch-free week, and three more consecutive weekly applications, or a cyclic regimen consisting of four consecutive cycles of three weekly applications and one patch-free week. Of the 235 women with information after randomization, 191 (81%) completed the study.
Although not statistically significant, there were more reports of headache, nausea, and breast discomfort in the extended group compared with the cyclic group. Twelve percent of women reported no bleeding or spotting during the entire 84 days of extended patch use. Researchers concluded that compared with cyclic use, extended use of the patch delayed menses and resulted in fewer bleeding days.
The study’s relatively short treatment duration did not allow a determination of the long-term efficacy, tolerability, and safety of the extended regimen, its researchers note. Any pregnancies or serious adverse events that may occur beyond 84 days of continuous transdermal patch use require further study in a long-term usage trial, they conclude.1
The ring’s study compared bleeding patterns and the acceptability of extended regimens with its standard 28-day cycle (21 days of use, followed by seven ring-free days). After study participants used the ring for one standard cycle, researchers randomly assigned them to one of four regimens to be used for one year: the standard regimen (21/7), six weeks of ring use (42/7), 12 weeks of ring use (84/7), or 51 weeks of ring use (357/7). Each ring was used for three weeks.
A total of 429 women were randomized for the study; 289 completed the year. Researchers report that longer regimens correlated with fewer bleeding days. Unscheduled bleeding, primarily spotting, was associated with the 84/7 and 357/7 regimens. All ring regimens were acceptable and well tolerated, the scientists conclude.3
The advantages of extended use fall within two categories. For women who have health problems that are related to cyclic hormonal changes, extended use is an effective treatment option, observes Felicia Stewart, MD, adjunct professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of California San Francisco and co-director of the Center for Reproductive Health Research & Policy in San Francisco. Both methods provide the same basic estrogen/progestin treatment pattern as extended use of oral contraceptives, with good suppression of ovulation and endogenous hormone production, she notes.
For women who do not have cyclic health problems, the advantage for the patch and the ring is that there is less to remember, says Stewart, who served as lead author of the Evra study. Instead of a daily "remembering" task, the total is reduced to four per month for patches and one per month for rings, she adds.
Leslie Miller, MD, associate professor of obstetrics and gynecology at the University of Washington and family planning medical director at Public Health Seattle King County, does not recommend extended or continuous use of the patch. Miller presented information on extended use of the contraceptive vaginal ring at the recent ACOG meeting and has published research on extended/ continuous use of oral contraceptives.4,5
According to Miller, increased levels of ethinyl estradiol levels during the third week of patch use during the third cycle of use with skipping of the patch-free week, make it possible that a woman will be exposed to a much higher amount of ethinyl estradiol, which potentially increases the risk for thrombosis.
"Although the patch releases 20 mcg of ethinyl estradiol, the absorption is almost 100%, and there is some accumulation by Week 3 when applied to the abdomen,"6 she states.
Miller says she would like to see a transdermal patch formulated especially for continuous use, perhaps with a lower dose of ethinyl estradiol, with a study performed on the safety of skipping the patch-free week more than once.
"Oral contraceptives, especially the 20-mcg ethinyl estradiol/levonorgestrel and norethindrone acetate formulations, are very safe; these newer products deliver the drugs differently and are possibly not just equivalent to pills,"7 states Miller.
References
- Thomas SL, Ellertson C. Nuisance or natural and healthy: Should monthly menstruation be optional for women? Lancet 2000; 355:922-924.
- Stewart FH, Kaunitz AM, LaGuardia KD, et al. Extended use of transdermal norelgestromin/ethinyl estradiol: A randomized trial. Obstet Gynecol 2005; 105:1,389-1,396.
- Miller L, Verhoeven CHJ. Results of a Randomized Multicenter Trial Comparing Extended Contraceptive Ring Regimens. Presented at the American College of Obstetricians and Gynecologists Annual Clinical Meeting. San Francisco; May 2005.
- Miller L, Notter KM. Menstrual reduction with extended use of combination oral contraceptive pills: Randomized controlled trial. Obstet Gynecol 2001; 98(5 Pt 1):771-778.
- Miller L, Hughes JP. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: A randomized trial. Obstet Gynecol 2003; 101:653-661.
- Abrams LS, Skee DM, Natarajan J, et al. Multiple-dose pharmacokinetics of a contraceptive patch in healthy women participants. Contraception 2001; 64:287-294.
- Lidegaard O, Edstrom B, Kreiner S. Oral contraceptives and venous thromboembolism: A five-year national case-control study. Contraception 2002; 65:187-196.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.