Birth control patch

"Evra patch" redirects here. For the brand of patch containing estradiol only, see Evorel patch.

Contraceptive patch

Ortho Evra brand of contraceptive patch

Background
Type| Hormonal (combined estrogen + progestin)
First use| 2002
Failure rates (first year)
Perfect use| 0.3%[1]
Typical use| 9%[1]
Usage
User reminders| Weekly application for 3 weeks
Clinic review| 3-6 monthly
Advantages and disadvantages
STI protection| No
Weight| No proven effect
Period advantages| Regulated, may be lighter and less painful
Benefits| Compared to oral pills, may be less affected by antibiotics
Risks| DVTs rates similar to oral combined pills
Norelgestromin/ethinyl estradiolCombination of

Norelgestromin| Progestogen
Ethinylestradiol| Estrogen
Names
Trade names| Ortho Evra, Xulane, Evra

IUPAC name

* (3Z,8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-3-hydroxyimino-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-ol;(8R,9S,13S,14S,17R)-17-ethynyl-13-methyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthrene-3,17-diol

Clinical data
Pregnancy
category|

* US: N (Not classified yet)

* Contraindicated

Routes of
use| Transdermal (patch)
External links
AHFS/Drugs.com| Professional Drug Facts
MedlinePlus| a602006
Legal
License data|

* EU EMA: by INN
* US DailyMed: Norelgestromin_and_ethinyl_estradiol

Legal status|

* CA: ℞-only
* UK: POM (Prescription only) [2]
* US: ℞-only
* In general: ℞ (Prescription only)

Identifiers
CAS Number|

* 53016-31-2 Y
* 57-63-6 Y

PubChem CID|

* 91758695

DrugBank|

* DB06713
* DB00977

ChemSpider|

* None

UNII|

* R0TAY3X631
* 423D2T571U Y

KEGG|

* D10839 Y

ATC code|

* G03AA13 (WHO)

Chemical and physical data
Formula| C41H53NO4
Molar mass| 623.878 g·mol−1
3D model (JSmol)|

* Interactive image

SMILES

* CCC12CCC3C(C1CCC2(C#C)O)CCC4=CC(=NO)CCC34.CC12CCC3C(C1CCC2(C#C)O)CCC4=C3C=CC(=C4)O

InChI

* 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 estradiolCombination of

Levonorgestrel| Progestogen
Ethinylestradiol| Estrogen
Names
Trade names| Twirla
Clinical data
Pregnancy
category|

* US: N (Not classified yet)

* Contraindicated

Routes of
use| Transdermal (patch)
Legal
License data|

* US DailyMed: Twirla

Legal status|

* US: ℞-only

Identifiers
ChemSpider|

* None

ATC code|

* G03AB03 (WHO)

Birth control patch, also known as contraceptive patch or the patch, is a patch applied to the skin to prevent pregnancy. They are as effective as the perfect use of combined birth control pill, and more effective than typical use.[3][4]

It works by releases versions of the hormones estrogen and progestogen.

Brand names include Evra,[5][6][7][6][7] Xulane,[8] and Twirla.[9] The patches are packaged in boxes of three and are available by prescription.[8]

## Contents

* 1 Medical uses
* 2 Side effects
* 2.1 Interactions
* 2.2 Thromboembolism
* 3 Method of use
* 3.1 Backup
* 4 Mechanism of action
* 5 Lawsuits
* 6 References
* 7 External links

## Medical uses[edit | edit source]

Because the patch works similar to that of birth control pills, many of the benefits are the same. For example, the patch may make periods 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, the ability to become pregnant returns quickly.[10]

## Side effects[edit | edit source]

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.[8][6][13]

### Interactions[edit | edit source]

Effectiveness of the patch or any other hormonal contraceptive may be reduced if taken alongside certain antibiotics, antifungals, anticonvulsants, or other drugs that increase metabolism of contraceptive steroids.

Despite the interactions with certain antibiotics, a study showed that tetracycline 500 mg by mouth for three days prior to and seven days during use of Ortho Evra did not reduce effectiveness. This is a factor in the common decision to administer tetracycline-derived antibiotics following an abortion (preventatively) when hormone contraceptives are to be used afterwards.

Drugs containing St. John's wort are also known to decrease 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 often not recommended in women older than 35 years who smoke cigarettes.[8]

The patch is also often not recommended in women with a BMI ≥ 30 kg/m2.[8]

### Thromboembolism[edit | edit source]

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[edit | edit source]

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[edit | edit source]

* 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[edit | edit source]

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).[8] The 20 cm2 Evra contraceptive patch contains 600 µg ethinylestradiol and 6000 µg norelgestromin.[6] 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.[8][6]

## Lawsuits[edit | edit source]

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 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.

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.[23]

## References[edit | edit source]

1. ↑ 1.0 1.1 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. ↑ "Evra Product information". Health Canada. 2018-06-21. Archived from the original on 2020-02-18. Retrieved 17 February 2020.
6. ↑ 6.0 6.1 6.2 6.3 6.4 "Evra transdermal patch - Summary of Product Characteristics (SmPC)". (emc). 29 November 2018. Archived from the original on 7 November 2017. Retrieved 17 February 2020.
7. ↑ 7.0 7.1 "Evra EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 12 November 2020. Retrieved 18 February 2020.
8. ↑ 8.0 8.1 8.2 8.3 8.4 8.5 8.6 "Xulane- norelgestromin and ethinyl estradiol patch". DailyMed. 19 April 2017. Archived from the original on 6 July 2020. Retrieved 17 February 2020.
9. ↑ "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. Archived from the original on 29 January 2021. Retrieved 17 February 2020.
10. ↑ "Birth Control Patch (Ortho Evra)". Planned Parenthood. 3 February 2011. Archived from the original on 11 April 2014. Retrieved 29 January 2023.
11. ↑ 11.0 11.1 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. ↑ 20.0 20.1 "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. Archived from the original on 2020-07-28. Retrieved 2023-01-29.
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. ↑ 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.

## External links[edit | edit source]

* "Ethinyl Estradiol mixture with norelgestromin". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2021-02-09. Retrieved 2023-01-29.
* Feminist Women's Health Center
* Planned Parenthood: The Patch Archived 2023-02-05 at the Wayback Machine

* v
* t
* e

Birth control methods (G02B, G03A)

Comparison|

* Comparison of birth control methods
* Long-acting reversible contraception (LARC)

Behavioral|

* Avoiding vaginal intercourse: Abstinence
* Anal sex
* Masturbation
* Non-penetrative sex
* Oral sex
Including vaginal intercourse: Breastfeeding infertility (LAM)
* Calendar-based methods (rhythm, etc.)
* Fertility awareness (Billings ovulation method
* Creighton Model, etc.)
* Withdrawal

Barrier and / or spermicidal|

* Cervical cap
* Condom
* Contraceptive sponge
* Diaphragm
* Female condom
* Lactic acid/citric acid/potassium bitartrate
* Spermicide

Hormonal
(formulations)|

| Combined estrogen-progestogen|

* Contraceptive patch
* Extended cycle
* Injectable
* Combined vaginal ring
* Pill

|

Progestogen-only|

* Depo-Provera
* Etonogestrel implant (Nexplanon)
* Levonorgestrel implant (Norplant)
* Progestogen-only pill
* Progesterone vaginal ring

Anti-estrogen|

* Ormeloxifene (Centchroman)

Post-intercourse|

* Emergency contraception (Ulipristal acetate
* Yuzpe regimen
* Levonorgestrel)

Intrauterine device|

* Copper
* Hormone

Sterilization|

* Female: Essure
* Tubal ligation
Male: Vasectomy

Experimental|

* Reversible inhibition of sperm under guidance (Vasalgel)

Long-acting reversible contraception (LARC)|

* Intrauterine device (Hormonal IUD
* Copper IUD)
* Contraceptive implant (Etonogestrel implant, Levonorgestrel implant)

* v
* t
* e

Hormonal contraception (G02B, G03A)

Androgens|

* Male-only: Dimethandrolone
* Testosterone buciclate
* Testosterone undecanoate
* Trestolone

Estrogens|

* Diethylstilbestrol
* Estradiol
* Estradiol benzoate
* Estradiol cypionate
* Estradiol enanthate
* Estradiol valerate
* Ethinylestradiol
* Mestranol
* Ormeloxifene

Progestogens|

| First generation (estranes)|

* Ethisterone
* Etynodiol diacetate
* Lynestrenol
* Norethisterone (norethindrone)
* Norethisterone acetate
* Norethisterone enanthate
* Noretynodrel
* Quingestanol

|

Second generation|

* Estranes: Norethisterone enanthate
* Norgestrienone
* Gonanes: Levonorgestrel
* Norelgestromin
* Norgestrel

Third generation (gonanes)|

* Desogestrel
* Etonogestrel
* Gestodene
* Norgestimate

Fourth generation|

* Estranes: Dienogest
* Norpregnanes: Demegestone
* Nomegestrol acetate
* Promegestone
* Trimegestone
* Spironolactone derivatives: Drospirenone

Pregnanes|

* Chlormadinone acetate
* Medrogestone
* Medroxyprogesterone acetate
* Megestrol acetate

Miscellaneous|

* Mifepristone
* Ulipristal acetate
* Algestone acetophenide
* Dydrogesterone
* Gestrinone
* Progesterone
* Proligestone

* v
* t
* e

Routes of administration, dosage forms

Oral|

| Digestive tract (enteral)|

| Solids|

* Tablet
* Capsule
* Pastille
* Time release technology
* Osmotic delivery system

|
|

Liquids|

* Decoction
* Elixir
* Electuary
* Emulsion
* Effervescent powder or tablet
* Herbal tea
* Hydrogel
* Molecular encapsulation
* Powder
* Softgel
* Solution
* Suspension
* Syrup
* Tincture

Buccal (sublabial),
sublingual|

| Solids|

* Orally disintegrating tablet
* Film
* Lollipop
* Sublingual drops
* Lozenges
* Effervescent tablet
* Chewing gum

|

Liquids|

* Mouthwash
* Toothpaste
* Ointment
* Spray

Respiratory tract|

| Solids|

* Dry-powder inhaler

|
|

Liquids|

* Anesthetic vaporizer
* Vaporizer
* Nebulizer
* Metered-dose inhaler (MDI)

Gas|

* Oxygen mask and Nasal cannula
* Oxygen concentrator
* Anaesthetic machine
* Relative analgesia machine

Ophthalmic,
otologic, nasal|

* Nasal spray
* Ear drops
* Eye drops
* Ointment
* Hydrogel
* Insufflation
* Mucoadhesive microdisc

Urogenital|

* Ointment
* Pessary
* Vaginal ring
* Douche
* Intrauterine device (IUD)
* Extra-amniotic infusion
* Intravesical infusion

Rectal (enteral)|

* Ointment
* Suppository
* Enema
* Solution
* Hydrogel
* Murphy drip
* Nutrient enema

Dermal|

* Ointment
* Topical cream
* Topical gel
* Liniment
* Paste
* Film
* DMSO solution
* Electrophoretic system
* Hydrogel
* Liposomes
* Transfersome vesicles
* Cream
* Lotion
* Lip balm
* Medicated shampoo
* Dermal patch
* Transdermal patch
* Transdermal spray
* Jet injector

Injection,
infusion
(into tissue/blood)

| Skin|

* Intradermal
* Subcutaneous

* Injector pen

* Transdermal implant

|
|

Organs|

* Intracavernous
* Intravitreal
* Intra-articular

Central nervous system|

* Intracerebral
* Intrathecal
* Epidural

Circulatory,
musculoskeletal|

* Intravenous
* Intracardiac
* Intramuscular
* Intraosseous
* Intraperitoneal
* Nanocell injection
* Patient-controlled analgesia pump
* PIC line

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