Contraceptive patch

A contraceptive patch, also known as "the patch", is a transdermal patch applied to the skin that releases synthetic oestrogen and progestogen hormones to prevent pregnancy. They have been shown to be as effective as the combined oral contraceptive pill with perfect use, and the patch may be more effective in typical use.[3][4]

Contraceptive patch
Ortho Evra brand of contraceptive patch
Background
TypeHormonal (combined estrogen + progestin)
First use2002
Failure rates (first year)
Perfect use0.3%[1]
Typical use9%[1]
Usage
User remindersWeekly application for 3 weeks
Clinic review3-6 monthly
Advantages and disadvantages
STI protectionNo
WeightNo proven effect
Period advantagesRegulated, may be lighter and less painful
BenefitsCompared to oral pills, may be less affected by antibiotics
RisksDVTs rates similar to oral combined pills
norelgestromin / ethinyl estradiol
Combination of
NorelgestrominProgestogen
EthinylestradiolEstrogen
Clinical data
Trade namesOrtho Evra, Xulane, Evra
AHFS/Drugs.comProfessional Drug Facts
MedlinePlusa602006
License data
Pregnancy
category
  • US: N (Not classified yet)
  • Contraindicated
Routes of
administration		Transdermal (patch)
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
  • None
UNII
KEGG
Chemical and physical data
FormulaC41H53NO4
Molar mass623.878 g·mol−1
3D model (JSmol)
levonorgestrel / ethinyl estradiol
Combination of
LevonorgestrelProgestogen
EthinylestradiolEstrogen
Clinical data
Trade namesTwirla
License data
Pregnancy
category
  • US: N (Not classified yet)
  • Contraindicated
Routes of
administration		Transdermal (patch)
ATC code
Legal status
Legal status
Identifiers
ChemSpider
  • None

Xulane[5] and Twirla[6] are approved for use in the United States. Evra is approved for use in Canada and marketed by Janssen Inc.;[7] and it is approved for use in the United Kingdom[8] and in Europe[9] and marketed by Janssen-Cilag.[8][9] The patches are packaged in boxes of three and are only available by prescription.[5]

Medical uses

Because the patch works similar to that of birth control pills, many of the benefits are the same. For example, the patch may make a woman's period lighter and more regular. It may also help to clear acne, decrease cramps, and reduce PMS symptoms. Additionally, the patch is associated with an increased protection against iron deficiency anemia, ovarian cysts, pelvic inflammatory disease, and endometrial and ovarian cancer.

The patch is a simple and convenient form of birth control that requires weekly attention. When a woman stops using the patch, her ability to become pregnant returns quickly.[10]

Side effects

In three large clinical trials involving a total of 3,330 women using the Ortho Evra / Evra patch for up to one year, 12% of users discontinued the patch because of adverse events. The most frequent adverse events leading to patch discontinuation were: nausea and/or vomiting (2.4%), application site reaction (1.9%), breast discomfort, engorgement or pain (1.9%), headache (1.1%), and emotional lability (1.0%).[11]

The most frequent adverse events reported while using the Ortho Evra / Evra patch were: breast discomfort, engorgement or pain (22%), headache (21%), application site reaction (17%), nausea (17%), upper respiratory tract infection (10%), menstrual cramps (10%), and abdominal pain (9%).[11]

Breakthrough bleeding and/or spotting while using the Ortho Evra / Evra patch was reported by: 18% in cycle 1, 12% in cycle 3, 8% in cycle 6 and cycle 13. Breakthrough bleeding (requiring more than one pad or tampon per day) was reported by: 4% in cycle 1, 3% in cycle 3 and cycle 6, and 1% in cycle 13.[12]

Overall, side effects that tend to go away after two or three months include bleeding between periods, breast tenderness, and nausea and vomiting. Symptoms that may last longer include skin irritation around the area where the patch is placed and a change in the woman's sexual desires.

Additional side effect information is provided in the Ortho Evra label information and the Evra Summary of Product Characteristics (SPC) and PIL.[5][8][13]

Interactions and contraindications

Contraceptive effectiveness of the patch or any other hormonal contraceptive may be reduced significantly if administered alongside various antibiotics, antifungals, anticonvulsants, or other drugs that increase metabolism of contraceptive steroids.

However, despite the interactions with many other antibiotics, a clinical pharmacokinetic drug interaction study showed that oral administration of tetracycline HCl 500 mg for three days prior to and seven days during use of Ortho Evra "did not reduce effectiveness of Ortho Evra." This is a significant factor in the common decision to administer tetracycline-derived antibiotics following an abortion (preventatively to fight potential infection) when synthetic hormone contraceptives are to be used afterwards.

Drugs containing St. John's Wort are also known to affect the effectiveness of hormonal contraceptives.

It has also been found that the patch is less effective in women who weigh more than 198 pounds (90 kg).

The contraceptive patch and other combination hormonal contraceptives are contraindicated in women older than 35 years who smoke cigarettes.[5]

The contraceptive patch is contraindicated for use in women with a BMI ≥ 30 kg/m2.[5]

Thromboembolism

All combined hormonal birth control products have a very small increased risk of serious or fatal thromboembolic events. There is ongoing research into the thromboembolic risks of Ortho Evra as compared to combined oral contraceptive pills. A recent study found that users of the contraceptive patch may have a twofold increased risk for non-fatal venous thromboembolic events compared with women who took a norgestimate-containing oral contraceptive with 35 µg of estrogen.[14][15] However, a different study concluded that the risk of nonfatal venous thromboembolism for the contraceptive patch is similar to the risk for oral contraceptives containing 35 µg of ethinylestradiol and norgestimate.[16] The contradiction in findings between the two studies is not easily resolved, because the confidence intervals for the studies are overlapping.

In studies with oral contraceptives, the risk for cardiovascular disease (such as thromboembolism) is significantly increased in women over the age of 35 years who also smoke tobacco.[17] Hence, Ortho-Evra's package insert states: "Women who use hormonal contraceptives, including Ortho Evra, should be strongly advised not to smoke."

According to the manufacturer, the patches introduce a 60% higher level of estrogen into the bloodstream as compared to oral contraceptives; however, the clinical significance of this difference is unknown.

On November 10, 2005 Ortho McNeil, in conjunction with the FDA, revised the label for Ortho Evra, including a new bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 µg of estrogen, noting that higher levels of estrogen may put some women at increased risk for getting blood clots. The label was again revised in September 2006, and on January 18, 2008, the FDA again updated the label to reflect study results. "The FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options."[18]

Method of use

A woman applies her first patch onto her upper outer arm, buttocks, abdomen or thigh on either the first day of her menstrual cycle (day 1) or on the first Sunday following that day, whichever she prefers. The day of application is known from that point as patch change day. Seven days later, when patch change day comes again, the woman removes the patch and applies another to one of the approved locations on the body. This process is repeated again on the next patch change day. On the following patch change day, the patch is removed and not replaced. The woman waits seven days without a patch in place, and on the next patch change day she applies a new patch. Extended use regimens, where patches are used for several weeks before a patch-free week, have been studied.[19]

The patch should be applied to skin that is clean, dry, and intact. This means, if skin is red, irritated, or cut, the patch should not be placed in that area. Additionally, avoid using lotions, powder, or makeup around the area where the patch is, or will be placed.[20]

Backup contraception
  • If a woman chooses to begin with her patch change day as day one of her menstrual cycle, the patch is able to take effect in time to prevent ovulation (see Mechanism of Action below) and no form of backup contraception is needed at all.
    • In the case that a woman wishes to begin using the contraceptive patch following a first trimester abortion or miscarriage, patch application can be done immediately afterwards. This can be considered the same as a day one start above, and no backup contraception is required.
  • If a woman chooses to begin with her patch change day as the first Sunday following day 1, it is necessary to use a backup form of contraception such as spermicide[21] or condoms for the first week of patch wear.
  • If a woman is late placing her patch in the first week, or more than two days late placing the patch in the second and third weeks, she should apply the patch immediately, and then use a back up form of barrier protection for a week.[22]

Mechanism of action
Illustration depicting transdermal contraceptive patch.

Like all combined hormonal contraceptives, Ortho Evra / Evra works primarily by preventing ovulation. A secondary mechanism of action is inhibition of sperm penetration by changes in the cervical mucus. Hormonal contraceptives also have effects on the endometrium that theoretically could affect implantation; however, no scientific evidence indicates that prevention of implantation actually results from their use.[23]

The 20 cm2 Ortho Evra contraceptive patch contains 750 µg ethinylestradiol (an estrogen) and 6000 µg norelgestromin (a progestin).[5] The 20 cm2 Evra contraceptive patch contains 600 µg ethinylestradiol and 6000 µg norelgestromin.[8] The Ortho Evra contraceptive patch and the Evra contraceptive patch are both intended to gradually release into the systemic circulation approximately 20 µg/day of ethinylestradiol and 150 µg/day of norelgestromin.[5][8]

Lawsuits

The patch has been associated with strokes and thrombosis and the mechanism for hormone absorption and dissipation from the body's tissues is different from "the pill." Several lawsuits have been instigated over these issues.

A lawsuit filed in Federal Court in New Jersey on September 2, 2005 by a Georgia woman who suffered a pulmonary embolism alleges the company promoted the patch despite knowledge of its health risks, for financial gain, while failing to warn of the risks of blood clots and other injuries.

In November 2005, CBS News aired a story about documents that surfaced in a lawsuit involving a young mother who was paralyzed by a stroke and remained a total invalid, which showed the company had received nearly 500 reports of adverse events between April 2002 and December 2004. During the same time frame, only 61 adverse event reports were filed in connection with all type of birth-control pills.[24]

The parents of a 14-year-old girl from Wisconsin have filed a lawsuit against Johnson & Johnson because they claim that she died from a blood clot that arose from her use of the patch.[25]

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References
  1. Trussell, James (2011). "Contraceptive efficacy". In Hatcher, Robert A.; Trussell, James; Nelson, Anita L.; Cates, Willard Jr.; Kowal, Deborah; Policar, Michael S. (eds.). Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 779–863. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734. Table 26–1 = Table 3–2 Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception, and the percentage continuing use at the end of the first year. United States.
  2. "Evra transdermal patch - Summary of Product Characteristics (SmPC)". (emc). 26 June 2020. Retrieved 4 July 2020.
  3. Trussell, James (2007). "Contraceptive Efficacy". In Hatcher, Robert A.; et al. (eds.). Contraceptive Technology (19th rev. ed.). New York: Ardent Media. ISBN 0-9664902-0-7.
  4. Contraceptive Technology, Chapter 12, Contraceptive Patch and Vaginal Contraceptive Ring, by Kavita Nanda, page 272
  5. "Xulane- norelgestromin and ethinyl estradiol patch". DailyMed. 19 April 2017. Retrieved 17 February 2020.
  6. "FDA Approves Agile Therapeutics, Inc.'s Twirla (levonorgestrel and ethinyl estradiol) Transdermal System – A New Weekly Contraceptive Patch Delivering a 30 mcg Daily Dose of Estrogen and 120 mcg Daily Dose of Progestin". Agile Therapeutics. 14 February 2020. Retrieved 17 February 2020.
  7. "Evra Product information". Health Canada. 2018-06-21. Retrieved 17 February 2020.
  8. "Evra transdermal patch - Summary of Product Characteristics (SmPC)". (emc). 29 November 2018. Retrieved 17 February 2020.
  9. "Evra EPAR". European Medicines Agency. 17 September 2018. Retrieved 18 February 2020.
  10. Planned Parenthood (2011). "Birth Control Patch (Ortho Evra)." Retrieved from http://www.plannedparenthood.org/health-topics/birth-control/birth-control-patch-ortho-evra-4240.htm, on February 3, 2011.
  11. Sibai BM, Odlind V, Meador ML, Shangold GA, Fisher AC, Creasy GW (2002). "A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho Evra/Evra)". Fertil Steril. 77 (2 Suppl 2): S19–26. doi:10.1016/S0015-0282(01)03264-2. PMID 11849632.
  12. Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, Creasy GW GW (2002). "Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data". Fertil Steril. 77 (2 Suppl 2): S13–8. doi:10.1016/S0015-0282(01)03275-7. PMID 11849631.
  13. Janssen-Cilag (January 26, 2007). "Evra Patient Information Leaflet (PIL)". Archived from the original on September 28, 2007. Retrieved 2007-07-20.
  14. Medpage Today. Evidence on Ortho Evra Patch Thrombosis Risk Is Contradictory Archived 2006-03-01 at the Wayback Machine. Published February 17, 2006.
  15. Cole JA, Norman H, Doherty M, Walker AM (February 2007). "Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users". Obstet Gynecol. 109 (2 Pt 1): 339–46. doi:10.1097/01.AOG.0000250968.82370.04. PMID 17267834.
  16. Jick S, Kaye JA, Li L, Jick H (July 2007). "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. 76 (1): 4–7. doi:10.1016/j.contraception.2007.03.003. PMID 17586129.
  17. Pitsavos C, Stefanadis C, Toutouzas P (2000). "Contraception in women at high risk or with established cardiovascular disease". Ann. N. Y. Acad. Sci. 900: 215–27. doi:10.1111/j.1749-6632.2000.tb06233.x. PMID 10818409.
  18. FDA Approves Update to Label on Birth Control Patch. FDA. January 18, 2008 Archived May 12, 2009, at the Wayback Machine
  19. Stewart FH, Kaunitz AM, Laguardia KD, Karvois DL, Fisher AC, Friedman AJ (June 2005). "Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial". Obstet Gynecol. 105 (6): 1389–96. doi:10.1097/01.AOG.0000160430.61799.f6. PMID 15932834.
  20. Mayo Clinic (2010). "Ortho Evra (Contraceptive Patch)." Retrieved from http://www.mayoclinic.com/health/ortho-evra/MY01006/DSECTION=what-you-can-expect, on February 3, 2011.
  21. https://picaboo.biz/what-is-spermicide-and-what-effects-does-it-have-on-our-body/ Picaboo.biz
  22. Mayo Clinic. "Ortho Evra (Contraceptive Patch)." Retrieved from http://www.mayoclinic.com/health/ortho-evra/MY01006/DSECTION=what-you-can-expect, on February 3, 2011
  23. Rivera R, Yacobson I, Grimes D (1999). "The mechanism of action of hormonal contraceptives and intrauterine contraceptive devices". Am J Obstet Gynecol. 181 (5 Pt 1): 1263–9. doi:10.1016/S0002-9378(99)70120-1. PMID 10561657.
  24. http://usa.mediamonitors.net/content/view/full/31895
  25. http://www.lacrossetribune.com/articles/2005/11/18/news/00lead.txt
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