Contraceptive patch

Last updated
Contraceptive patch
Contraceptivepatch.jpg
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
Risks DVTs rates similar to oral combined pills
norelgestromin / ethinyl estradiol
Combination of
Norelgestromin Progestogen
Ethinylestradiol Estrogen
Clinical data
Trade names Ortho Evra, Xulane, Evra
AHFS/Drugs.com Professional Drug Facts
MedlinePlus a602006
License data
Pregnancy
category
  • 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
Formula C41H53NO4
Molar mass 623.878 g·mol−1
3D model (JSmol)
  • CCC12CCC3C(C1CCC2(C#C)O)CCC4=CC(=NO)CCC34.CC12CCC3C(C1CCC2(C#C)O)CCC4=C3C=CC(=C4)O
  • InChI=1S/C21H29NO2.C20H24O2/c1-3-20-11-9-17-16-8-6-15(22-24)13-14(16)5-7-18(17)19(20)10-12-21(20,23)4-2;1-3-20(22)11-9-18-17-6-4-13-12-14(21)5-7-15(13)16(17)8-10-19(18,20)2/h2,13,16-19,23-24H,3,5-12H2,1H3;1,5,7,12,16-18,21-22H,4,6,8-11H2,2H3/b22-15-;/t16-,17+,18+,19-,20-,21-;16-,17-,18+,19+,20+/m01/s1
  • Key:KBFRRZPPJPKFHQ-WKXKRCMPSA-N
levonorgestrel / ethinyl estradiol
Combination of
Levonorgestrel Progestogen
Ethinylestradiol Estrogen
Clinical data
Trade names Twirla
License data
Pregnancy
category
  • Contraindicated
Routes of
administration 		Transdermal (patch)
ATC code
Legal status
Legal status
Identifiers
ChemSpider
  • None

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]

Contents

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 similarly 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 increased protection against iron deficiency anemia, ovarian cysts, pelvic inflammatory disease, and endometrial and ovarian cancer.[ medical citation needed ]

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.[ medical citation needed ] 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.[ medical citation needed ]

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.[ medical citation needed ]

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.[ medical citation needed ]

Drugs containing St. John's wort are also known to affect the effectiveness of hormonal contraceptives.[ medical citation needed ]

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.[ medical citation needed ]

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

The patch is first applied onto the upper outer arm, buttocks, abdomen or thigh on either the first day of the menstrual cycle (day 1) or on the first Sunday following that day, whichever is preferred. The day of application is known from that point as patch change day. Seven days later, when patch change day comes again, the user 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 user waits seven days without a patch in place, and on the next patch change day they apply 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 someone chooses to begin with their patch change day as day one of their 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 one 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 user chooses to begin with their 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 the user is late placing her patch in the first week, or more than two days late placing the patch in the second and third weeks, they should apply the patch immediately, and then use a backup form of barrier protection for a week. [20]

Mechanism of action

Illustration depicting transdermal contraceptive patch Blausen 0080 BirthControlPatch.png
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. [22]

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. [23]

A lawsuit filed in Federal Court in New Jersey on September 2, 2005, by a Georgia woman who had 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. [23]

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. [24]

Related Research Articles

<span class="mw-page-title-main">Combined oral contraceptive pill</span> Birth control method which is taken orally

The combined oral contraceptive pill (COCP), often referred to as the birth control pill or colloquially as "the pill", is a type of birth control that is designed to be taken orally by women. It is the oral form of combined hormonal contraception. The pill contains two important hormones: a progestin and estrogen. When taken correctly, it alters the menstrual cycle to eliminate ovulation and prevent pregnancy.

<span class="mw-page-title-main">Ethinylestradiol</span> Estrogen medication

Ethinylestradiol (EE) is an estrogen medication which is used widely in birth control pills in combination with progestins. In the past, EE was widely used for various indications such as the treatment of menopausal symptoms, gynecological disorders, and certain hormone-sensitive cancers. It is usually taken by mouth but is also used as a patch and vaginal ring.

Extended or continuous cycle combined oral contraceptive pills are a packaging of combined oral contraceptive pills (COCPs) that reduce or eliminate the withdrawal bleeding that would occur once every 28 days in traditionally packaged COCPs. It works by reducing the frequency of the pill-free or placebo days. Extended cycle use of COCPs may also be called menstrual suppression, although other hormonal medications or medication delivery systems may also be used to suppress menses. Any brand of combined oral contraceptive pills can be used in an extended or continuous manner by simply discarding the placebo pills; this is most commonly done with monophasic pills in which all of the pills in a package contain the same fixed dosing of a synthetic estrogen and a progestin in each active pill.

<span class="mw-page-title-main">Desogestrel</span> Medication

Desogestrel is a progestin medication which is used in birth control pills for women. It is also used in the treatment of menopausal symptoms in women. The medication is available and used alone or in combination with an estrogen. It is taken by mouth.

<span class="mw-page-title-main">Drospirenone</span> Medication drug

Drospirenone is a progestin and antiandrogen medication which is used in birth control pills to prevent pregnancy and in menopausal hormone therapy, among other uses. It is available both alone under the brand name Slynd and in combination with an estrogen under the brand name Yasmin among others. The medication is an analog of the drug spironolactone. Drospirenone is taken by mouth.

<span class="mw-page-title-main">Norethisterone acetate</span> Chemical compound

Norethisterone acetate (NETA), also known as norethindrone acetate and sold under the brand name Primolut-Nor among others, is a progestin medication which is used in birth control pills, menopausal hormone therapy, and for the treatment of gynecological disorders. The medication available in low-dose and high-dose formulations and is used alone or in combination with an estrogen. It is ingested orally.

<span class="mw-page-title-main">Norelgestromin</span> Pharmaceutical drug

Norelgestromin, or norelgestromine, sold under the brand names Evra and Ortho Evra among others, is a progestin medication which is used as a method of birth control for women. The medication is available in combination with an estrogen and is not available alone. It is used as a patch that is applied to the skin.

<span class="mw-page-title-main">Norgestimate</span> Chemical compound

Norgestimate, sold under the brand names Ortho Tri-Cyclen and Previfem among others, is a progestin medication which is used in birth control pills for women and in menopausal hormone therapy. The medication is available in combination with an estrogen and is not available alone. It is taken by mouth.

<span class="mw-page-title-main">Gestodene</span> Progestin medication

Gestodene, sold under the brand names Femodene and Minulet among others, is a progestin medication which is used in birth control pills for women. It is also used in menopausal hormone therapy. The medication is available almost exclusively in combination with an estrogen. It is taken by mouth.

<span class="mw-page-title-main">Mestranol</span> Chemical compound

Mestranol, sold under the brand names Enovid, Norinyl, and Ortho-Novum among others, is an estrogen medication which has been used in birth control pills, menopausal hormone therapy, and the treatment of menstrual disorders. It is formulated in combination with a progestin and is not available alone. It is taken by mouth.

Birth control pills come in a variety of formulations. The main division is between combined oral contraceptive pills, containing both estrogens and synthetic progestogens (progestins), and progestogen only pills. Combined oral contraceptive pills also come in varying types, including varying doses of estrogen, and whether the dose of estrogen or progestogen changes from week to week.

<span class="mw-page-title-main">Drospirenone/ethinylestradiol/levomefolic acid</span> Pharmaceutical combination

Drospirenone/ethinylestradiol/levomefolic acid (EE/DRSP/LMF), sold under the brand name Beyaz among others, is a combination of ethinylestradiol (EE), an estrogen, drospirenone (DRSP), a progestogen, antimineralocorticoid, and antiandrogen, and levomefolic acid (LMF), a form of vitamin B9, which is used as a birth control pill to prevent pregnancy in women. The formulation contains folate as the calcium salt of levomefolic acid to lower the risk of complications such as fetal neural tube defects should the medication fail as a form of birth control. EE/DRSP/LMF was approved for use by the US Food and Drug Administration (FDA) in September 2010.

<span class="mw-page-title-main">Segesterone acetate</span> Progestin medication

Segesterone acetate (SGA), sold under the brand names Nestorone, Elcometrine, and Annovera, is a progestin medication which is used in birth control and in the treatment of endometriosis in the United States, Brazil, and other South American countries. It is available both alone and in combination with an estrogen. It is not effective by mouth and must be given by other routes, most typically as a vaginal ring or implant that is placed into fat.

Combined birth control pills that contain natural estradiol or an estradiol ester include:

<span class="mw-page-title-main">Estradiol (medication)</span> Steroidal hormone medication

Estradiol (E2) is a medication and naturally occurring steroid hormone. It is an estrogen and is used mainly in menopausal hormone therapy and to treat low sex hormone levels in women. It is also used in hormonal birth control for women, in feminizing hormone therapy for transgender women, and in the treatment of hormone-sensitive cancers like prostate cancer in men and breast cancer in women, among other uses. Estradiol can be taken by mouth, held and dissolved under the tongue, as a gel or patch that is applied to the skin, in through the vagina, by injection into muscle or fat, or through the use of an implant that is placed into fat, among other routes.

Norelgestromin/ethinylestradiol, sold under the brand name Ortho Evra among others, is a contraceptive patch containing the progestin norelgestromin and the estrogen ethinylestradiol.

<span class="mw-page-title-main">Ethinylestradiol/etonogestrel</span> Pharmaceutical birth control combination

Ethinylestradiol/etonogestrel, sold under the brand names NuvaRing among others, is a hormonal vaginal ring used for birth control and to improve menstrual symptoms. It contains ethinylestradiol, an estrogen, and etonogestrel, a progestin. It is used by insertion into the vagina. Pregnancy occurs in about 0.3% of women with perfect use and 9% of women with typical use.

<span class="mw-page-title-main">Combined hormonal contraception</span> Form of hormonal contraception combining both an estrogen and a progestogen

Combined hormonal contraception (CHC), or combined birth control, is a form of hormonal contraception which combines both an estrogen and a progestogen in varying formulations.

<span class="mw-page-title-main">Ethinylestradiol/cyproterone acetate</span> Combination drug

Ethinylestradiol/cyproterone acetate (EE/CPA), also known as co-cyprindiol and sold under the brand names Diane and Diane-35 among others, is a combination of ethinylestradiol (EE), an estrogen, and cyproterone acetate (CPA), a progestin and antiandrogen, which is used as a birth control pill to prevent pregnancy in women. It is also used to treat androgen-dependent conditions in women such as acne, seborrhea, excessive facial/body hair growth, scalp hair loss, and high androgen levels associated with ovaries with cysts. The medication is taken by mouth once daily for 21 days, followed by a 7-day free interval.

References

  1. 1 2 Trussell J (2011). "Contraceptive efficacy". In Hatcher RA, Trussell J, Nelson AL, Cates Jr W, Kowal D, Policar MS (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. Archived 2017-02-15 at the Wayback Machine
  2. ↑ "Evra transdermal patch - Summary of Product Characteristics (SmPC)". (emc). 26 June 2020. Archived from the original on 24 October 2020. Retrieved 4 July 2020.
  3. ↑ Trussell J (2007). "Contraceptive Efficacy". In Hatcher RA, et al. (eds.). Contraceptive Technology (19th rev. ed.). New York: Ardent Media. ISBN   978-0-9664902-0-6.
  4. ↑ Nanda K, Burke A (2011). "Contraceptive patch and vaginal contraceptive ring.". In Hatcher RA, Nelson AL, Trussell J, Cwiak C, Cason P, Policar MS, Edelman A, Aiken AR, Marrazzo J, Kowal D (eds.). Contraceptive Technology (twentieth ed.). Atlanta, Georgia: Ardent Media, Inc. p. 272. ISBN   978-1-59708-004-0.
  5. 1 2 3 4 5 6 7 "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. 1 2 3 4 5 "Evra transdermal patch - Summary of Product Characteristics (SmPC)". (emc). 29 November 2018. Archived from the original on 7 November 2017. Retrieved 17 February 2020.
  9. 1 2 "Evra EPAR". European Medicines Agency. 17 September 2018. Retrieved 18 February 2020.
  10. ↑ "Birth Control Patch (Ortho Evra)". Planned Parenthood. 3 February 2011.
  11. 1 2 Sibai BM, Odlind V, Meador ML, Shangold GA, Fisher AC, Creasy GW (February 2002). "A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho Evra/Evra)". Fertility and Sterility. 77 (2 Suppl 2): S19–S26. doi: 10.1016/S0015-0282(01)03264-2 . PMID   11849632.
  12. ↑ Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, Creasy GW (February 2002). "Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data". Fertility and Sterility. 77 (2 Suppl 2): S13–S18. 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". Obstetrics and Gynecology. 109 (2 Pt 1): 339–346. doi:10.1097/01.AOG.0000250968.82370.04. PMID   17267834. S2CID   1572286.
  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". Annals of the New York Academy of Sciences. 900 (1): 215–227. Bibcode:2000NYASA.900..215P. doi:10.1111/j.1749-6632.2000.tb06233.x. PMID   10818409. S2CID   45035196.
  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". Obstetrics and Gynecology. 105 (6): 1389–1396. doi:10.1097/01.AOG.0000160430.61799.f6. PMID   15932834. S2CID   8831803.
  20. 1 2 "Ortho Evra (Contraceptive Patch)". Mayo Clinic. 2010. Archived from the original on 15 October 2012. Retrieved 3 February 2011.
  21. ↑ "What is spermicide?". Picaboo.biz.
  22. ↑ Rivera R, Yacobson I, Grimes D (November 1999). "The mechanism of action of hormonal contraceptives and intrauterine contraceptive devices". American Journal of Obstetrics and Gynecology. 181 (5 Pt 1): 1263–1269. doi:10.1016/S0002-9378(99)70120-1. PMID   10561657.
  23. 1 2 Tim (2006-10-26). "FDA warns of contraceptive patch dangers - Parker & Waichman". Parker Waichman LLP. Retrieved 2024-04-06.
  24. ↑ Schott K, Foley RJ (18 November 2005). "Family sues birth control maker over death of daughter, 14". The La Crosse Tribune. The Associated Press. Archived from the original on 26 October 2008.
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