New Product Review (September 2003). Norelgestromin/ethinyl oestradiol transdermal contraceptive system (Evra).
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چکیده
This new transdermal contraceptive system (contraceptive patch), Evra (Janssen-Cilag), received a UK product licence in 2003. In clinical trials: Consistent doses of norelgestromin and ethinyl oestradiol are released into the systemic circulation daily. Pharmacokinetic data suggest that levels are sufficient to inhibit ovulation for at least 7 days. The overall Pearl index for the contraceptive patch (1.24; 95% CI 0.19-2.33) was similar to that of a triphasic combined oral contraceptive (COC) pill (2.18; 95% CI 0.57-3.8). Self-reported "perfect" compliance was significantly better with the contraceptive patch (88.2%) than with a combined contraceptive pill (77.7%). Patch detachment, requiring replacement with a new patch, with normal daily activity is uncommon (4.6%). Breakthrough bleeding and spotting were significantly more common with the contraceptive patch than with combined oral contraception in the first two cycles but differences were not significant by cycle three. In general, reported side effects were not significantly different with contraceptive patch or combined pill use. However, breast tenderness in the first two treatment cycles was more common with patch use. Symptoms were mild to moderate in 85% of women and were rarely treatment limiting. Currently, there are limited data regarding risk of venous thromboembolism, and cervical or breast cancer with the contraceptive patch. No clinically significant alterations in metabolic or haemostatic parameters were identified with contraceptive patch use. A month's supply of the contraceptive patch costs 7.74 UK pounds. Combined oral contraception prices range from approximately 0.80 to 5.00 UK pounds and hormone replacement therapy patches range from 10.00 to 13.00 UK pounds. The contraceptive patch offers additional choice for women who wish to use a combined hormonal method of contraception.
منابع مشابه
Norelgestromin/ethinyl estradiol transdermal system.
The transdermal contraceptive patch is an innovative contraceptive technology. The failure rate is quite low and has high continuation rate. The side effects and complications are not different from other hormonal contraceptives. This contraceptive method should be an alternative birth control technique for women.
متن کاملA review of transdermal hormonal contraception : focus on the ethinylestradiol/norelgestromin contraceptive patch.
Imperfect use of contraceptive methods notably increases the likelihood of pregnancy. One means of improving user adherence with hormonal contraception is to minimize the dosing schedule. Two forms of hormonal contraceptive have currently achieved this goal: the transdermal patch and the vaginal ring. The first and only transdermal contraceptive patch to receive worldwide regulatory approval (e...
متن کاملExtended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial.
OBJECTIVE To compare bleeding profiles and satisfaction among women using a norelgestromin/ethinyl estradiol (E2) transdermal contraceptive patch in an extended regimen to those among women using a traditional 28-day patch regimen. METHODS Healthy, regularly menstruating women (N = 239) were randomly assigned (2:1 ratio) to receive the norelgestromin/ethinyl E2 transdermal patch in an extende...
متن کاملMathematical Modeling of the Release of Active Ingredients from a Contraceptive Patch: Ortho Evra® as a Case Study
Contraceptive patches have become a frequently used contraceptive method. We present a mathematical model that describes the serum concentration profiles of Norelgestromin (NGMN) and Ethinylestradiol (EE) released from the contraceptive patch Ortho Evra(®). We propose a simple one-compartment model based on pharmacokinetics data reported in previous studies. The model assumes a time-dependent r...
متن کاملSafety, efficacy and patient acceptability of the combined estrogen and progestin transdermal contraceptive patch: a review
The worldwide introduction of the first, unique patch for hormonal contraception (ethinyl estradiol/norelgestromin, EE/NGMN patch) was widely recognized as a significant event in the development of drug delivery systems. This innovation offers a number of advantages over the oral route, and extensive clinical trials have proved its safety, efficacy, effectiveness, and tolerability. The weekly a...
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ورودعنوان ژورنال:
- The journal of family planning and reproductive health care
دوره 30 1 شماره
صفحات -
تاریخ انتشار 2004