Data out on potential contraceptive patch
Data out on potential contraceptive patch
Results of a paper presented at the recent Annual Clinical Meeting of the American College of Obstetricians and Gynecologists suggest that an investigational low-dose contraceptive patch appears to be as effective as a combined oral contraceptive (COC).1
The Phase III pivotal trial of Agile Therapeutics' AG200-15 patch was designed as a open-label, randomized, comparative, parallel-group, multicenter study of the patch against a 20 mcg ethinyl estradiol/0.1 mg levonorgestrel oral contraceptive. The two patches were studied for contraceptive efficacy, cycle control, subject compliance, and safety. Study enrollment included women reflective of the general U.S. population, including obese women, minorities, smokers, and women with and without previous hormonal contraceptive use.
The Phase 3 trial found that the low-estrogen patch is as effective as conventional oral contraceptives, says Andrew Kaunitz, MD, professor and associate chair in the Obstetrics and Gynecology Department at the University of Florida College of Medicine — Jacksonville. An additional finding of the trial is that the efficacy of the Agile patch did not decline in obese women, says Kaunitz, who served as lead investigator of the study.
The patch' s developer, Agile Therapeutics of Princeton, NJ, has submitted a New Drug Application for the device to the Food and Drug Administration (FDA). The patch releases low doses of ethinyl estradiol and levonorgestrel for contraceptive effectiveness.
Some women find such a weekly patch regimen more convenient than a daily pill regimen.2 When the Ortho Evra patch (Ortho Women' s Health & Urology, Raritan, NJ) was approved by FDA the in 2001, it became a popular form of birth control. However, use of the Ortho patch dropped after its labeling was edited to address issues relating to the risk of venous thrombotic events and exposure to contraceptive hormones seen with Ortho Evra as compared to certain OCs.
Check study results
Women in the AG200-15 study group were treated for one year (13 cycles) with the patch, and subjects in the COC group were treated for six cycles with the study pill, followed by seven cycles of AG200-15 use. Overall, 1,503 women (1,128 AG200-15 users; 375 COC users) were included in the study; age range was 17 to 40, with a mean age of 26.4.
A little more than half of the women identified themselves (55%) as white/non-Hispanic in the patch and pills groups; 15% and 19% identified themselves as white/Hispanic; 24% and 21% as black; 3.5% and 3.2% as Asian; and 2.4% and 2.7% as other. A total of 27% and 29% identified themselves as smokers in the patch and pill groups. The mean body mass index (BMI) was 27.5. Most women (60%) were new users of hormonal contraceptives; 14% switched from another birth control method. Blood draws for drug level determination and pharmacokinetic evaluations were performed for all subjects at cycles 2 ,6, and 13.
The overall Pearl Index score for women on the patch was 4.96, compared with a score of 4.02 for women on the study pill. However, when the efficacy analysis excluded women whose blood levels indicated nonuse of study contraceptive, the Pearl Index was 3.1 for the patch and 3.8 for the study pill. The Pearl Index score on the patch was 2.85 for women with a BMI greater than 32 kg/m2 (kilograms divided by height in meters squared), compared with an index score of 3.17 for women with a lower BMI.
Pharmacokinetics eyed
To evaluate the pharmacokinetic profile of the patch, scientists designed an open-label, three-period, crossover study, randomizing 24 women to use the patch on the abdomen, buttock, or upper torso. Each patch was worn on the site for seven days, followed by a seven-day washout before application of a new patch to the next anatomical site. Application of the study patch to different anatomical sites yielded similar levonorgestrel and ethinyl estradiol exposures, with all sites well within ranges reported for low-dose, combined oral contraceptives.3
This patch releases estrogen in amounts equivalent to a 30-mg ethinyl estradiol pill, using area-under-the-curve analyses, says Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles. "In these days, with worries about the thrombotic potential of the progestins, readers should be reassured by the fact that the progestin in this patch is levonorgestrel," she notes.
Place for patch?
The Agile investigational patch is applied once weekly for three weeks, followed by a fourth patch-free week. Additional research presented at the annual meeting indicates the patch will stay in place and continue to deliver hormones under a variety of external conditions, such as whirlpool, sauna, or vigorous exercise.4 The patch is circular in shape and softer than other patches clinicians have prescribed in the past, says Nelson.
The initial popularity of the Evra patch when it became available some 10 years ago underscores that many women are interested in using transdermal contraception, says Kaunitz. Availability of the Agile patch could lead to transdermal contraception returning as a popular contraceptive choice for U.S. women, he notes.
References
- Kaunitz AM, Mishell DR, Foegh ML. Comparative Phase 3 Study of AG200-15, a Low-Dose Estrogen and Levonorgestrel Contraceptive Patch. Presented at the 60th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. San Diego; May 2012.
- Nanda K. Contraceptive patch and vaginal contraceptive ring. In: Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive Technology: 20th revised edition. New York: Ardent Media; 2011.
- Stanczyk FZ, Archer DF, Foegh M. The Pharmacokinetic Profile of a Low-Dose Contraceptive Patch is Equivalent at Three Anatomical Sites. Presented at the 60th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. San Diego; May 2012.
- Archer DF, Stanczyk FZ, Foegh ML. Adhesiveness and Pharmacokinetics of a Low-Dose Contraceptive Patch under Daily External Stressors. Presented at the 60th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. San Diego; May 2012.
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