|First use 1970s||STI protection No|
|Type Hormonal (progestin or others) or intrauterine|
Perfect use ECP: see article text IUD: under 1%
Typical use % (please see Effectiveness of ECPs below)
User reminders Pregnancy test required if no period seen after 3 weeks
Emergency contraception (EC), or emergency postcoital contraception, are birth control measures that may be used after sexual intercourse to prevent pregnancy.
- Emergency contraceptive pills
- Types of ECPs
- History of calculation methods
- Side effects
- Intrauterine device
- As regular contraception
- Relationship to high risk sex and abortion
- EC and sexual assault
- Mechanism of action
- Plan B
Forms of EC include:
Emergency contraceptive pills
Emergency contraceptive pills (ECPs) (sometimes referred to as emergency hormonal contraception (EHC)) may contain higher doses of the same hormones (estrogens, progestins, or both) found in regular combined oral contraceptive pills. Taken after unprotected sexual intercourse or contraceptive failure, such higher doses may prevent pregnancy from occurring.
Types of ECPs
Three types of emergency contraceptive pills are available: combined estrogen and progestin pills, progestin-only (levonorgestrel) pills, and antiprogestin (ulipristal acetate or mifepristone) pills. Progestin-only and antiprogestin pills are available as dedicated (specifically packaged for use as) emergency contraceptive pills. Combined estrogen and progestin pills are no longer available as dedicated emergency contraceptive pills, but certain regular combined oral contraceptive pills may be used as emergency contraceptive pills.
Progestin-only emergency contraceptive pills contain levonorgestrel, either as a single tablet or as a split dose of two tablets taken 12 hours apart, effective up to 72 hours after intercourse. Progestin-only ECPs are sold under many different brand names. Progestin-only ECPs are available over-the-counter (OTC) in several countries (e.g. Bangladesh, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, India, Netherlands, Norway, Portugal, Romania, Slovakia, South Africa, Sweden, United States), from a pharmacist without a prescription, and available with a prescription in some other countries.
The antiprogestin ulipristal acetate is available as a micronized emergency contraceptive tablet, effective up to 120 hours after intercourse. Ulipristal acetate ECPs developed by HRA Pharma are available by prescription in over 50 countries under the brand names ellaOne, ella (marketed by Watson Pharmaceuticals in the United States), Duprisal 30, Ulipristal 30, and UPRIS.
The antiprogestin mifepristone (also known as RU-486) is available in five countries as a low-dose or mid-dose emergency contraceptive tablet, effective up to 120 hours after intercourse. Low-dose mifepristone ECPs are available by prescription in Armenia, Russia, Ukraine, and Vietnam and from a pharmacist without a prescription in China. Mid-dose mifepristone ECPs are available by prescription in China and Vietnam.
Combined estrogen (ethinylestradiol) and progestin (levonorgestrel or norgestrel) pills used to be available as dedicated emergency contraceptive pills under several brand names: Schering PC4, Tetragynon, Neoprimavlar, and Preven (in the United States) but were withdrawn after more effective dedicated progestin-only (levonorgestrel) emergency contraceptive pills with fewer side effects became available. If other more effective dedicated emergency contraceptive pills (levonorgestrel, ulipristal acetate, or mifepristone) are not available, specific combinations of regular combined oral contraceptive pills can be taken in split doses 12 hours apart (the Yuzpe regimen), effective up to 72 hours after intercourse. The U.S. Food and Drug Administration (FDA) approved this off-label use of certain brands of regular combined oral contraceptive pills in 1997. As of 2014, there are 26 brands of regular combined oral contraceptive pills containing levonorgestrel or norgestrel available in the United States that can be used in the emergency contraceptive Yuzpe regimen.
The effectiveness of emergency contraception is presented differently from the effectiveness of ongoing methods of birth control: it is expressed as a percentage reduction in pregnancy rate for a single use of EC. Different ECP regimens have different effectiveness levels, and even for a single regimen different studies may find varying rates of effectiveness. Using an example of "75% effective", an article in American Family Physician explains the effectiveness calculation thus:
... these numbers do not translate into a pregnancy rate of 25 percent. Rather, they mean that if 1,000 women have unprotected intercourse in the middle two weeks of their menstrual cycles, approximately 80 will become pregnant. Use of emergency contraceptive pills would reduce this number by 75 percent, to 20 women.
The progestin-only regimen (using levonorgestrel) is reported by the U.S. FDA to have an 89% effectiveness. As of 2006, the labeling on the U.S. brand Plan B explained this effectiveness rate by stating, "Seven out of every eight women who would have gotten pregnant will not become pregnant."
In 1999, a meta-analysis of eight studies of the combined (Yuzpe) regimen concluded that the best point estimate of effectiveness was 74%. A 2003 analysis of two of the largest combined (Yuzpe) regimen studies, using a different calculation method, found effectiveness estimates of 47% and 53%.
For both the progestin-only and Yuzpe regimens, the effectiveness of emergency contraception is highest when taken within 12 hours of intercourse and declines over time. While most studies of emergency contraception have only enrolled women within 72 hours of unprotected intercourse, a 2002 study by the World Health Organization (WHO) suggested that reasonable effectiveness may continue for up to 120 hours (5 days) after intercourse.
For 10 mg of mifepristone taken up to 120 hours (5 days) after intercourse, the combined estimate from three trials was an effectiveness of 83%. A review found that a moderate dose of mifepristone is better than LNG or Yuzpe.
HRA Pharma changed its packaging information for Norlevo (which has dosage and chemical makeup identical to many other EHCs) in November 2013 warning that the drug loses effectiveness in women who weigh more than 165 pounds and is completely ineffective for women who weigh over 176 pounds.
History of calculation methods
Early studies of emergency contraceptives did not attempt to calculate a failure rate; they simply reported the number of women who became pregnant after using an emergency contraceptive. Since 1980, clinical trials of emergency contraception have first calculated probable pregnancies in the study group if no treatment were given. The effectiveness is calculated by dividing observed pregnancies by the estimated number of pregnancies without treatment.
Placebo-controlled trials that could give a precise measure of the pregnancy rate without treatment would be unethical, so the effectiveness percentage is based on estimated pregnancy rates. These are currently estimated using variants of the calendar method. Women with irregular cycles for any reason (including recent hormone use such as oral contraceptives and breastfeeding) must be excluded from such calculations. Even for women included in the calculation, the limitations of calendar methods of fertility determination have long been recognized. In their February 2014 emergency review article, Trussell and Raymond note:
Calculation of effectiveness, and particularly the denominator of the fraction, involves many assumptions that are difficult to validate...The risk of pregnancy for women requesting ECPs appears to be lower than assumed in the estimates of ECP efficacy, which are consequently likely to be overestimates. Yet, precise estimates of efficacy may not be highly relevant to many women who have had unprotected intercourse, since ECPs are often the only available treatment.
In 1999, hormonal assay was suggested as a more accurate method of estimating fertility for EC studies.
Existing pregnancy is not a contraindication in terms of safety, as there is no known harm to the woman, the course of her pregnancy, or the fetus if progestin-only or combined emergency contraception pills are accidentally used, but EC is not indicated for a woman with a known or suspected pregnancy because it is not effective in women who are already pregnant.
The World Health Organization (WHO) lists no medical condition for which the risks of emergency contraceptive pills outweigh the benefits. The American Academy of Pediatrics (AAP) and experts on emergency contraception have concluded that progestin-only ECPs may be preferable to combined ECPs containing estrogen in women with a history of blood clots, stroke, or migraine.
The AAP, American College of Obstetricians and Gynecologists (ACOG), U.S. Food and Drug Administration, WHO, Royal College of Obstetricians and Gynaecologists, and other experts on emergency contraception state that there are no medical conditions in which progestin-only ECPs are contraindicated. RCOG specifically note current venous thromboembolism, current or past history of breast cancer, inflammatory bowel disease, and acute intermittent porphyria as conditions where the advantages of using emergency contraceptive pills generally outweigh the theoretical or proven risks.
ECPs, like all other contraceptives, reduce the absolute risk of ectopic pregnancy by preventing pregnancies and there is no increase in the relative risk of ectopic pregnancy in women who become pregnant after using progestin-only ECPs.
The herbal preparation of St John's wort and some enzyme-inducing drugs (e.g. anticonvulsants or rifampicin) may reduce the effectiveness of ECP, and a larger dose may be required.
The most common side effect reported by users of emergency contraceptive pills was nausea (50.5% of 979 Yuzpe regimen users and 23.1% of 977 levonorgestrel-only users in the 1998 WHO trial; 14.3% of 2,720 levonorgestrel-only users in the 2002 WHO trial); vomiting is much less common and unusual with levonorgestrel-only ECPs (18.8% of 979 Yuzpe regimen users and 5.6% of levonorgestrel-only users in the 1998 WHO trial; 1.4% of 2,720 levonorgestrel-only users in the 2002 WHO trial). Anti-emetics are not routinely recommended with levonorgestrel-only ECPs. If a woman vomits within 2 hours of taking a levonorgestrel-only ECP, she should take a further dose as soon as possible.
Other common side effects (each reported by less than 20% of levonorgestrel-only users in both the 1998 and 2002 WHO trials) were abdominal pain, fatigue, headache, dizziness, and breast tenderness. Side effects usually do not occur for more than a few days after treatment, and they generally resolve within 24 hours.
Temporary disruption of the menstrual cycle is also commonly experienced. If taken before ovulation, the high doses of progestogen in levonorgestrel treatments may induce progestogen withdrawal bleeding a few days after the pills are taken. One study found that about half of women who used levonorgestrel ECPs experienced bleeding within 7 days of taking the pills. If levonorgestrel is taken after ovulation, it may increase the length of the luteal phase, thus delaying menstruation by a few days. Mifepristone, if taken before ovulation, may delay ovulation by 3–4 days (delayed ovulation may result in a delayed menstruation). These disruptions only occur in the cycle in which ECPs were taken; subsequent cycle length is not significantly affected. If a woman's menstrual period is delayed by two weeks or more, it is advised that she take a pregnancy test. (Earlier testing may not give accurate results.)
An alternative to emergency contraceptive pills is the copper-T intrauterine device (IUD) which can be used up to 5 days after unprotected intercourse to prevent pregnancy. Insertion of an IUD is more effective than use of Emergency Contraceptive Pills - pregnancy rates when used as emergency contraception are the same as with normal IUD use. IUDs may be left in place following the subsequent menstruation to provide ongoing contraception (3–10 years depending upon type).
As regular contraception
One brand of levonorgestrel pills was marketed as an ongoing method of postcoital contraception. However, there are serious drawbacks to such use of postcoital high-dose progestin-only oral contraceptive pills, especially if they are not used according to their package directions, but are instead used according to the package directions of emergency contraceptive pills:
ECPs are generally recommended for backup or "emergency" use, rather than as the primary means of contraception. They are intended for use when other means of contraception have failed—for example, if a woman has forgotten to take a birth control pill or when a condom is torn during sex.
Relationship to high risk sex and abortion
The current (December 2012) American Academy of Pediatrics (AAP) Policy Statement on Emergency Contraception says: "Despite multiple studies showing no increased risk behavior and evidence that hormonal emergency contraception will not disrupt an established pregnancy, public and medical discourse reflects that personal values of physicians and pharmacists continue to affect emergency-contraception access, particularly for adolescents."
The latest (December 2013) review by emergency contraception experts Trussell and Raymond says: "Published evidence would seem to demonstrate convincingly that making ECPs more widely available does not increase risk-taking or adversely affect regular contraceptive use". . . ."However, reanalysis of one of the randomized trials suggests that easier access to ECPs may have increased the frequency of coital acts with the potential to lead to pregnancy." and notes that four randomized controlled trials have found that advanced provision of emergency contraceptive pills did not increase rates of sexually transmitted infections or sexual risk taking. Trussell and Raymond noted that after one of the four studies had been reanalysed later, the data did show higher sexual risk-taking, specifically substituting in some cases emergency contraceptives for contraceptives such as condoms that are more effective.
In France, Sweden, and Britain—where Yuzpe-regimen EC had been available by prescription for more than a decade and progestin-only EC has been available without a prescription for 8, 6, and 2 years respectively—the abortion rate was stable or higher during that time period. Another study concluded that distribution of free, advance supplies of EC to large numbers of women in Scotland did not reduce abortion rates. A randomized controlled trial of 2000 women in China compared women with advance access to EC to women without access, and noted that the pregnancy rate was the same between the two groups. The study observed that "...providing EC in advance increases use, but there is no direct evidence that it reduces unintended pregnancy" and concluded that EC may not lower abortion rates.
In September 2006, emergency contraception expert Anna Glasier wrote a BMJ editorial entitled "Emergency Contraception. Is it worth all the fuss?" that said in closing: "So is emergency contraception worth the fuss? If you are a woman who has had unprotected sex then of course it is, because emergency contraception will prevent pregnancy in some women some of the time—and if you don’t want to get pregnant anything is better than nothing. If you are the CMAJ’s editor or FDA commissioner then yes, because scientific freedom is worth the fight. If you are looking for an intervention that will reduce abortion rates, emergency contraception may not be the solution, and perhaps you should concentrate most on encouraging people to use contraception before or during sex, not after it."
EC and sexual assault
Before EC was used in the general population or defined as "emergency contraception," it was used, beginning in the 1960s and 70s, specifically as a treatment for victims of sexual assault. Pregnancy rates among rape victims of child-bearing age are around 5%; in the U.S., about half of rape victims who become pregnant have abortions. Although EC is commonly used as an option for victims of sexual assault, some researchers believe such use is a public health measure that is not sufficiently widespread.
Mechanism of action
The primary mechanism of action of progestogen-only emergency contraceptive pills is to prevent fertilization by inhibition of ovulation. The best available evidence is that they do not have any post-fertilization effects such as the prevention of implantation. The U.S. FDA-approved labels and European EMA-approved labels (except for HRA Pharma's NorLevo) levonorgestrel emergency contraceptive pills (based on labels for regular oral contraceptive pills) say they may cause endometrial changes that discourage implantation. Daily use of regular oral contraceptive pills can alter the endometrium (although this has not been proven to interfere with implantation), but the isolated use of a levonorgestrel emergency contraceptive pill does not have time to alter the endometrium. In March 2011, the International Federation of Gynecology and Obstetrics (FIGO) issued a statement that: "review of the evidence suggests that LNG [levonorgestreol] ECPs cannot prevent implantation of a fertilized egg. Language on implantation should not be included in LNG ECP product labeling." In June 2012, a New York Times editorial called on the FDA to remove from the label the unsupported suggestion that levonorgestrel emergency contraceptive pills inhibit implantation. In November 2013, the European Medicines Agency (EMA) approved a change to the label for HRA Pharma's NorLevo saying it cannot prevent implantation of a fertilized egg.
Progestogen-only emergency contraceptive does not appear to effect the function of the Fallopian tubes or increase the rate of ectopic pregnancies.
The primary mechanism of action of progesterone receptor modulator emergency contraceptive pills like low-dose and mid-dose mifepristone and ulipristal acetate is to prevent fertilization by inhibition or delay of ovulation. One clinical study found that post-ovulatory administration of ulipristal acetate altered the endometrium, but whether the changes would inhibit implantation is unknown. The European EMA-approved labels for ulipristal acetate emergency contraceptive pills do not mention an effect on implantation, but the U.S. FDA-approved label says: "alterations to the endometrium that may affect implantation may also contribute to efficacy."
The primary mechanism of action of copper-releasing intrauterine devices (IUDs) as emergency contraceptives is to prevent fertilization because of copper toxicity to sperm and ova. The very high effectiveness of copper-releasing IUDs as emergency contraceptives means they must also prevent some pregnancies by post-fertilization effects such as prevention of implantation.
In 1966, gynecologist John McLean Morris and biologist Gertrude Van Wagenen at the Yale School of Medicine reported the successful use of oral high-dose estrogen pills as post-coital contraceptives in women and rhesus macaque monkeys, respectively. A few different drugs were studied, with a focus on high-dose estrogens, and it was originally hoped that postcoital contraception would prove viable as an ongoing contraceptive method.
The first widely used methods were five-day treatments with high-dose estrogens, using diethylstilbestrol (DES) in the US and ethinylestradiol in the Netherlands by Dr. Haspels.
In the early 1970s, the Yuzpe regimen was developed by A. Albert Yuzpe in 1974; progestin-only postcoital contraception was investigated (1975); and the copper IUD was first studied for use as emergency contraception (1975). Danazol was tested in the early 1980s in the hopes that it would have fewer side effects than Yuzpe, but was found to be ineffective.
The Yuzpe regimen became the standard course of treatment for postcoital contraception in many countries in the 1980s. The first prescription-only combined estrogen-progestin dedicated product, Schering PC4 (ethinylestradiol and norgestrel), was approved in the UK in January 1984 and first marketed in October 1984. Schering introduced a second prescription-only combined product, Tetragynon (ethinylestradiol and levonorgestrel) in Germany in 1985. By 1997, Schering AG dedicated prescription-only combined products had been approved in only 9 countries: the UK (Schering PC4), New Zealand (Schering PC4), South Africa (E-Gen-C), Germany (Tetragynon), Switzerland (Tetragynon), Denmark (Tetragynon), Norway (Tetragynon), Sweden (Tetragynon) and Finland (Neoprimavlar); and had been withdrawn from marketing in New Zealand in 1997 to prevent it being sold over-the-counter.   Regular combined oral contraceptive pills (which were less expensive and more widely available) were more commonly used for the Yuzpe regimen even in countries where dedicated products were available.
Over time, interest in progestin-only treatments increased. The Special Program on Human Reproduction (HRP), an international organization whose members include the World Bank and World Health Organization, "played a pioneering role in emergency contraception" by "confirming the effectiveness of levonorgestrel." After the WHO conducted a large trial comparing Yuzpe and levonorgestrel in 1998, combined estrogen-progestin products were gradually withdrawn from some markets (Preven in the United States discontinued May 2004, Schering PC4 in the UK discontinued October 2001, and Tetragynon in France) in favor of progestin-only EC, although prescription-only dedicated Yuzpe regimen products are still available in some countries.
In 2002, China became the first country in which mifepristone was registered for use as EC.