Contraceptive patch, ring: In U.S. by 2001?
For those women who have difficulty remembering to take a daily pill, two new contraceptive options — a transdermal patch and a vaginal ring — may be available by the end of 2001, if approved by the Food and Drug Administration (FDA).
Research has just been published on the Ortho Evra contraceptive patch, developed by the R.W. Johnson Pharmaceutical Research Institute in Raritan, NJ, and the NuvaRing contraceptive vaginal ring, to be marketed in the United States by Organon in West Orange, NJ.1,2
According to Ortho-McNeil Pharmaceuticals in Raritan, NJ, which will market the Ortho patch, the product’s New Drug Application was filed with the FDA in December 2000 and is under review. (Read more about the dosing trial
and patient compliance experience with the patch in the March 2001 issue of Contraceptive Technology Update, p. 29.)
The NuvaRing contraceptive vaginal ring also is moving through FDA channels, states Nancy Alexander, PhD, director of contraception at Organon. The device has just received approval, via the European mutual recognition procedure, for Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Ireland, Italy, Norway, Portugal, Spain, and Sweden, she says.
Organon plans a "clinical experience" program involving some 6,000 obstetrician/gynecologists prior to the commercial launch of the NuvaRing, says Alexander. The program will allow providers to become comfortable with the new method prior to prescription, she states.
Look for more research on the NuvaRing to be published in the near future, reports Alexander. (Contraceptive Technology Update will report results of these papers in upcoming issues.)
Ovarian suppression compares with OCs
In the currently published paper, a small study examining ovulation function, findings indicate that the NuvaRing completely inhibited ovulation throughout the normal three-week period and a two-week extended period of use.2 Ovarian suppression was comparable to that with a combination oral contraceptive (OC) containing ethinyl estradiol and desogestrel, according to the study.
The ring, which carries a combination of the progestin etonogestrel and the estrogen ethinyl estradiol, is designed to be worn three weeks, then removed for one week. In a separate study, results indicate that the device offers good cycle control with favorable patient compliance.3
Taking a daily pill can be a problem for many women. In a study evaluating consistency of use of OCs, 47% of users missed one or more pills per cycle, and 22% missed two or more doses.4
The contraceptive vaginal ring represents a major development in terms of options for women, says Michael Rosenberg, MD, MPH, clinical professor of obstetrics and gynecology at the school of medicine and adjunct professor of epidemiology at the school of public health, both at the University of North Carolina at Chapel Hill, and president of Health Decisions, a Chapel Hill private research firm specializing in reproductive health.
By being able to insert the ring and remove it 21 days later, the need is removed for taking a daily pill, observes Rosenberg.
"The biggest compliance problem with the ring — and a minor one at that — is remembering to remove it after day 21," notes Rosenberg.
The ease of use of the Ortho Evra patch may be its greatest strength, comments William Koltun, MD, director of the Medical Center for Clinical Research in San Diego and co-author of the efficacy/cycle control paper.
"The Ortho Evra patch requires essentially three actions by the patient during the course of
a 30-day period, vs. the birth control pill, which requires 28 different actions, taking a pill daily," Koltun remarks. "I think that its safety and efficacy are equal to the birth control pill, and if you can reduce the frequency of things that people have to do to guarantee efficacy, you will provide a product with which people feel more comfortable."
Patch effective as Pill
The Ortho Evra patch relies on the progestin/ estrogen combination of norelgestromin and ethinyl estradiol for its contraceptive effectiveness. It is designed to be worn on several areas of a woman’s body, but most typically it is placed on the lower abdomen or buttocks. The patch is worn for one week at a time and is changed on the same day of the week three times a month. The fourth week is patch-free.
In the study analyzing the contraceptive efficacy and cycle control of the patch vs. an OC, the patch was found comparable to the Pill in both areas.1 The randomized, multicenter study followed 1,417 women ages 18-45 for up to 13 monthly cycles.
In looking at contraceptive efficacy, researchers determined that the overall and method-failure Pearl Indexes were numerically lower in the patch group, although the differences between the treatments were not statistically different. Four method-failure pregnancies and one user-failure pregnancy occurred among 811 women treated for 5,240 cycles in the patch group; in the OC group, four method-failure pregnancies and three user-failure pregnancies occurred among 605 women treated for 4,167 cycles.
As for cycle control, breakthrough bleeding and/or spotting was significantly higher only in the first two cycles in the patch group. The incidence of breakthrough bleeding alone was comparable between treatments in all cycles, state the investigators.
Compliance with the dosing schedule of the patch was better than that of the OC, the study indicates. The observation that improved compliance may result in lower typical-use contraceptive failure rates needs to be confirmed in larger studies, the researchers conclude.
References
1. Audet MC, Moreau M, Koltun WD, et al. ORTHO EVRA/EVRA 004 Study Group. Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs. an oral contraceptive: A randomized controlled trial. JAMA 2001; 285:2,347-2,354.
2. Mulders TM, Dieben TO. Use of the novel combined contraceptive vaginal ring NuvaRing for ovulation inhibition. Fertil Steril 2001; 75:865-870.
3. Roumen FJ, Apter D, Mulders TM, et al. Efficacy, tolerability, and acceptability of a novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol. Hum Reprod 2001; 16:469-475.
4. Rosenberg MJ, Waugh MS, Burnhill MS. Compliance, counseling, and satisfaction with oral contraceptives: A prospective evaluation. Fam Plann Perspect 1998; 30:89-92, 104.
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