In a Phase 3 trial of an investigational contraceptive patch—known for the time being as AG200-15, under development by Agile Therapeutics—women were more compliant with the patch than with an oral contraceptive (OC).1 Over the first six cycles of the study, the percentage of cycles with perfect compliance was significantly higher among patch users than among women taking the pill (90.5% vs 78.8%; P <.001). In addition, compliance with the patch rose steadily over the first six cycles of the study, while compliance with the pill declined. Compliance was defined as no missed days of contraception in the cycle.
The AG200-15 patch is applied weekly and contains low-dose ethinyl estradiol in combination with levonorgestrel (LNG). The OC used in the study was Levlite (Berlex), a formulation containing 20 μg ethinyl estradiol and 0.1 mg LNG.
Data from the Phase 3 trial were presented at the annual meeting of the Association of Reproductive Health Professionals in late September. Findings were presented in a poster presentation by Andrew M. Kaunitz, MD, David F. Archer, MD, and Marie Foegh, MD, DrSc. Dr. Kaunitz is Associate Chair and Professor of Obstetrics and Gynecology at the University of Florida-Jacksonville and serves on the OBG Management Board of Editors. Dr. Archer is Director of the CONRAD Clinical Research Center and Professor of Obstetrics and Gynecology at Eastern Virginia Medical School. Dr. Foegh is Chief Medical Officer of Agile Therapeutics.
In the open-label, randomized, parallel-group, multicenter study, 1,328 women were treated for 1 year (13 cycles) with a patch (n = 998) or for six cycles with an OC, followed by seven cycles of the patch (n = 330). Women recorded their patch-application and pill-taking behavior in a diary.
The mean age of women in this study was 26.4 years; 60% were new users of hormonal contraception; 33% were obese; and 46% were non-Caucasian. Although there was no difference in the rate of compliance between obese and nonobese women using the patch or pill, compliance did vary by race and ethnicity, age, and education.
“Noncompliance among contraceptive users is an ongoing challenge,” Dr. Kaunitz said, “as the effectiveness of a contraceptive can decrease if it is not used correctly. The once-weekly regimen of AG200-15 is intended to be simple to use correctly, and we are encouraged to see that in this clinical trial, compliance was better with AG200-15 than with an oral contraceptive.”
Patch performed favorably in other measures, too
In a poster presentation at the 2012 annual clinical meeting of the American College of Obstetricians and Gynecologists,2 Dr. Kaunitz and colleagues presented Phase 3 data on the efficacy, cycle control, and safety of AG200-15, compared with a low-dose OC.
Overall, 1,503 women were randomly assigned to the patch (n = 1,128) or to the OC (n = 375). The women in both groups had comparable age, racial and ethnic demographics, body mass index, and smoking status. A majority of women (60%) were new users of hormonal contraception; 14% had switched from another contraceptive.
The patch had contraceptive efficacy similar to that of the pill, among both obese and nonobese participants; there were no clinically meaningful differences in efficacy between groups. Cycle control was also similar between groups.
The patch was well tolerated, with a low rate of adverse effects. For example, four women (1.2%) in the OC group and 14 women in the patch group (1.3%) experienced a serious adverse event (SAE). One SAE (0.3%) in the OC group (liver problem) and three SAEs (0.3%) in the patch group (drug overdose with diphenhydramine, vomiting, and left subclavian venous thrombosis in a nonobese woman with risk factors) were thought to be possibly or probably related to the study drug.2
Agile recently filed a new drug application for AG200-15 with the US Food and Drug Administration and anticipates a response during the first quarter of 2013.
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