Transdermal contraceptive patch
- Ronald T Burkman, MD
Ronald T Burkman, MD
- Department of Obstetrics and Gynecology
- Tufts University School of Medicine
The benefits, risks, and contraindications of the transdermal contraceptive patch are generally similar to those of combined hormonal oral contraceptives. Both methods offer highly effective, reversible, noncoital-based contraception, but are subject to adverse estrogen-related side effects. However, transdermal hormonal contraceptive systems offer several potential advantages to oral contraceptive pills:
●Therapeutic effects are achieved at lower peak doses since first-pass hepatic metabolism and enzymatic degradation in the gastrointestinal tract are avoided.
●Plasma hormone levels remain constant (peaks and troughs do not occur).
●Sustained drug delivery reduces the need for frequent self-administration, and thus may improve patient compliance.
●The nonoral route of administration is useful for patients who have difficulty swallowing pills.To continue reading this article, you must log in with your personal, hospital, or group practice subscription. For more information on subscription options, click below on the option that best describes you:
- US Food and Drug Administration. Combating Counterfeit Drugs. www.fda.gov/oc/initiatives/counterfeit/. (Accessed on January 04, 2008).
- Ortho Evra (norelgestromin/ethinyl estradiol transdermal system). Product labeling. Raritan, NJ: Ortho-McNeil Pharmaceutical, Inc, Revised September 2006.
- Xulane (norelgestromin/ethinyl estradiol transdermal system). Product labeling. Morgantown, WV; Mylan Pharmaceuticals, Inc. Revised March 2016. https://www.xulane.com/-/media/xulanecom/files/neets-r12_exhibit-pdf.pdf (Accessed on November 17, 2016).
- van den Heuvel MW, van Bragt AJ, Alnabawy AK, Kaptein MC. Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception 2005; 72:168.
- Devineni D, Skee D, Vaccaro N, et al. Pharmacokinetics and pharmacodynamics of a transdermal contraceptive patch and an oral contraceptive. J Clin Pharmacol 2007; 47:497.
- Lopez LM, Grimes DA, Gallo MF, et al. Skin patch and vaginal ring versus combined oral contraceptives for contraception. Cochrane Database Syst Rev 2013; :CD003552.
- Hedon B, Helmerhorst FM, Cronje HS, et al. Comparison of efficacy, cycle control, compliance, and safety in users of a contraceptive patch versus an oral contraceptive. BJOG 2000; 70:78.
- Audet MC, Moreau M, Koltun WD, et al. Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial. JAMA 2001; 285:2347.
- Smallwood GH, Meador ML, Lenihan JP, et al. Efficacy and safety of a transdermal contraceptive system. Obstet Gynecol 2001; 98:799.
- Archer DF, Bigrigg A, Smallwood GH, et al. Assessment of compliance with a weekly contraceptive patch (Ortho Evra/Evra) among North American women. Fertil Steril 2002; 77:S27.
- Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep 2016; 65:1.
- Lopez LM, Newmann SJ, Grimes DA, et al. Immediate start of hormonal contraceptives for contraception. Cochrane Database Syst Rev 2012; 12:CD006260.
- Stewart FH, Kaunitz AM, Laguardia KD, et al. Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial. Obstet Gynecol 2005; 105:1389.
- Zacur HA, Hedon B, Mansour D, et al. Integrated summary of Ortho Evra/Evra contraceptive patch adhesion in varied climates and conditions. Fertil Steril 2002; 77:S32.
- Abrams LS, Skee D, Natarajan J, et al. Tetracycline HCL does not affect the pharmacokinetics of a contraceptive patch. Int J Gynecol Obstet 2000; 70:57.
- Johnson JV, Lowell J, Badger GJ, et al. Effects of oral and transdermal hormonal contraception on vascular risk markers: a randomized controlled trial. Obstet Gynecol 2008; 111:278.
- Kluft C, Meijer P, LaGuardia KD, Fisher AC. Comparison of a transdermal contraceptive patch vs. oral contraceptives on hemostasis variables. Contraception 2008; 77:77.
- Douketis JD, Ginsberg JS, Holbrook A, et al. A reevaluation of the risk for venous thromboembolism with the use of oral contraceptives and hormone replacement therapy. Arch Intern Med 1997; 157:1522.
- O'Brien SH, Koch T, Vesely SK, Schwarz EB. Hormonal Contraception and Risk of Thromboembolism in Women With Diabetes. Diabetes Care 2017; 40:233.
- American College of Obstetricians and Gynecologists. Thromboembolism in pregnancy. ACOG Practice Bulletin 19, ACOG, Washington DC 2000.
- Heit JA, Kobbervig CE, James AH, et al. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study. Ann Intern Med 2005; 143:697.
- Heinemann LA, Dinger JC. Range of published estimates of venous thromboembolism incidence in young women. Contraception 2007; 75:328.
- US Food and Drug Administration. Background Document for Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management. Advisory Committee. NDA 21-180 Ortho Evra. www.fda.gov (Accessed on January 25, 2012).
- Blanco-Molina A, Monreal M. Venous thromboembolism in women taking hormonal contraceptives. Expert Rev Cardiovasc Ther 2010; 8:211.
- Jick SS, Kaye JA, Russmann S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception 2006; 73:223.
- Jick S, Kaye JA, Li L, Jick H. Further results on the risk of nonfatal venous thromboembolism in users of the contraceptive transdermal patch compared to users of oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception 2007; 76:4.
- Jick SS, Hagberg KW, Hernandez RK, Kaye JA. Postmarketing study of ORTHO EVRA and levonorgestrel oral contraceptives containing hormonal contraceptives with 30 mcg of ethinyl estradiol in relation to nonfatal venous thromboembolism. Contraception 2010; 81:16.
- Jick SS, Hagberg KW, Kaye JA. ORTHO EVRA and venous thromboembolism: an update. Contraception 2010; 81:452.
- Dore DD, Norman H, Loughlin J, Seeger JD. Extended case-control study results on thromboembolic outcomes among transdermal contraceptive users. Contraception 2010; 81:408.
- FDA Office of Surveillance and Epidemiology. Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf (Accessed on February 03, 2012).
- Lidegaard Ø, Løkkegaard E, Jensen A, et al. Thrombotic stroke and myocardial infarction with hormonal contraception. N Engl J Med 2012; 366:2257.
- Fleischer K, van Vliet HA, Rosendaal FR, et al. Effects of the contraceptive patch, the vaginal ring and an oral contraceptive on APC resistance and SHBG: a cross-over study. Thromb Res 2009; 123:429.
- Burkman RT. Transdermal hormonal contraception: benefits and risks. Am J Obstet Gynecol 2007; 197:134.e1.
- Sibai BM, Odlind V, Meador ML, et al. A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho Evra/Evra). Fertil Steril 2002; 77:S19.
- White T, Jain JK, Stanczyk FZ. Effect of oral versus transdermal steroidal contraceptives on androgenic markers. Am J Obstet Gynecol 2005; 192:2055.
- Stanczyk FZ, Archer DF, Rubin A, Foegh M. Therapeutically equivalent pharmacokinetic profile across three application sites for AG200-15, a novel low-estrogen dose contraceptive patch. Contraception 2013; 87:744.
- Archer DF, Stanczyk FZ, Rubin A, Foegh M. Pharmacokinetics and adhesion of the Agile transdermal contraceptive patch (AG200-15) during daily exposure to external conditions of heat, humidity and exercise. Contraception 2013; 87:212.
- Foegh M, Archer DF, Stanczyk FZ, et al. Ovarian activity in obese and nonobese women treated with three transdermal contraceptive patches delivering three different doses of ethinyl estradiol and levonorgestrel. Contraception 2013; 87:201.
- STRUCTURE AND PHARMACOLOGY
- MECHANISM OF ACTION
- Patient selection
- - Contraindications
- Screening requirements
- Extended cycle use
- Patch management
- - Applying and changing the patch
- - Delayed patch changes
- - Detached patch
- NONCONTRACEPTIVE BENEFITS
- RISK OF THROMBOTIC EVENTS
- Summary of data from epidemiological studies
- - Boston collaborative drug surveillance program (BCDSP) data
- - Data from other studies
- Effect on coagulation factors
- SIDE EFFECTS
- FUTURE DIRECTIONS
- SOCIETY GUIDELINE LINKS
- INFORMATION FOR PATIENTS
- SUMMARY AND RECOMMENDATIONS