Postcoital Contraception, 1970


To the editor: In view of the correspondence between Drs. Paulshock, Andersen, and Hayman and particularly Dr. Hayman’s statement,

“I know of no reports in the literature showing that estrogen has been administered to humans directly after insemination and has prevented nidation”

(Ann Intern Med 72:961, 1970), it might be worth calling your readers’ attention to the two articles from our Department. I believe the doses of estrogen suggested by Drs. Paulshock and Andersen are too small to give consistent protection against pregnancy.

Fifty milligrams of diethylstilbestrol (Stilbestrol®) a day for 5 days appears to be effective; 20 mg of premarin, intravenously, has also been used with success.

As these are actually postovulatory rather than postcoital contraceptives, timing is of the greatest importance, especially if there has been more than one exposure during the cycle.



Letter: Ectopic pregnancy after postcoital diethylstilbestrol

Letter 1

The report of Drs. A. R. Smythe II and P. B. Underwood, Jr., attributes the ocurrence of a tubal pregnancy to failure of high doses of postcoital stilbestrol to prevent pregnancy. This assumption is almost certainly erroneous. In a series of papers, my associates and I presented irrefutable evidence, including basal body temperature charts taken during cycles of fertilization, which indicated that ectopic conception with few exceptions precedes, not follows, the patient’s last recorded menstrual period. In other words, at the time of the “condom accident,” in the authors’ reported case, on Day 14 of the cycle the patient must have been pregnant for about three weeks.

Significantly. all previously reported “method failures” with diethylstilbestrol that had been reviewed by the authors had apparently resulted in ectopic gestation. In view of current knowledge concerning the pathologic mechanism of extrauterine pregnancies, this observation indicates that the drug, if given in adequate doses and at the appropriate time, invariably prevents pregnancy.

The association of ovulation defects and their accompanying phenomena with various pathologic conditions of gestation is a very interesting problem that has been in the center of interest of prominent reproductive biologists in recent years. Therefore, it is unfortunate that obstetricians continue to ignore the relevant data despite their considerable academic and clinical significance.
Leslie Iffy, M.D.

Letter 2

In reply to Dr. Iffy’s letter regarding ectopic pregnancies after postcoital diethylstilhestrol, I disagree with both of his points. The duration of time from this patient’s last menstrual period until a positive pregnancy test was seven weeks and five days and exactly nine weeks until the time of tubal rupture. From Dr. Iffy’s theory, she would have been 13 weeks pregnant. The abortion was a tubal abortion with an intact tubal serosa and no grossly recognizable fetus.

I do agree that a woman may have normal menses with a developing tubal pregnancy but certainly not always. In this patient, the condom accident was followed in the proper time sequence by missed menses, symptoms of pregnancy, a positive pregnancy test, and then the tubal abortion. For these reasons, I believe that the date of nine weeks from the last menstrual period is the more accurate gestational age.

As for Dr. Iffy’s second point that stilbestrol invariably prevents pregnancy, evidence strongly opposes this, as illustrated in this case and the review of the 9,000 exposures reported by Dr. John Morris as referred to in the original manuscript. I do agree that a Pearl index of 0.4 indicates a highly successful means of preventing pregnancy.

I appreciate the opportunity to answer Dr. Iffy’s letter and regret that I disagree with him; however, disagreements usually enlighten all parties involved and make medicine a challenging frontier.
Paul B. Underwood, Jr., M.D.


  • Letter: Ectopic pregnancy after postcoital diethylstilbestrol, American journal of obstetrics and gynecology, PMID: 937419, 1976 July.
  • Image credit Anthony Tran.

DES sold over the counter, in Kenya, to induce abortions

Kenyan women using animal abortion pills
by David Odongo, August 2013

“The worrying revelations that married women lead in procuring illegal abortion also paints a grim picture on the drugs used to induce the process.

We can now establish that most Nairobi women are readily using livestock hormonal growth drug, Estradiol to induce abortions. Estradiol is available in many vet clinics for Sh200 per dose.

But there are women who prefer Stilboestrol, a drug used to terminate pregnancies in bitches (female dogs), which is available for Sh150 per dose.

According to vet Kenneth Wameyo these drugs are sometimes sold over the counter.

“Well, from the chemist counter it is known as diethyistilboestrol but the common name is Stroel. A pack of 30 tablets costs about Sh500 although one cannot misuse the entire thirty tablets,”

says Wameyo.

But for those women who cannot get the vet drugs, prefer to use ulcers tablets. The most common being Cytotec and Misoprostol that can be easily bought over the counter for Sh90 per tablet at various city pharmacies. Only three tablets are needed to procure an abortion.

Mioprostol is not used orally but inserted into the private parts to avoid deadly side effects.

“The drug has very unpleasant side effects, including nausea and vomiting. So, to reduce side effects, they insert it to be absorbed into the bloodstream,”

says Wameyo.

Medic Polin Karimi explains that some women place Misoprostol under the tongue.

“When used this way, no remains of the drug can even be traced when one goes to the hospital incase of complications. There is no way to prove that one tried to induce abortion and doctors will assume it’s normal miscarriage,”

She adds, that thereafter, the doctors will just do a procedure known as curettage, or vacuum aspiration, which will remove remaining tissue from the womb.

The success rate of using misoprostol under the tongue is 95 per cent and when inserted, the success rate is 93 per cent

According to the latest research by Ministry of Health, African Population and Health Research Centre, Ipas, and Guttmacher Institute an astonishing 465,000 women procured illegal abortion last year.

Over 64 per cent of married women or those living with their partners sought post-abortion care in health facilities while 27.8 per cent have never been married and 7.5 per cent were divorced.

The highest sub-group of women who sought after-abortion care was that of unemployed housewives at 41.7 per cent.

How women abort using Misoprostol

When one swallows a dose of Mifepristone tablets by mouth, it causes the placenta to separate from the endometrium. It also softens the cervix and increases uterine contractions to allow the uterine contents to pass.

Within four hours of taking the second misoprostol, many women have vaginal bleeding and cramping, and the pregnancy is terminated.

Most pregnancies end within the first 24 hours after the Misoprostol dose. If not, then typically a second dose is given.

Signs of complications

Karimi advises that one should see a doctor immediately if she has any of these symptoms after taking Misoprostol.

“Severe bleeding which may include passing clots that are bigger than a golf ball, lasting two or more hours or soaking more than two large pads in an hour, for two hours in a row or just bleeding heavily for 12 hours in a row,”

she said.

She said the swelling or redness in the genital area, vomiting lasting more than four to six hours is not also a good sign and sudden abdominal swelling, rapid heart rate and vaginal discharge that has increased in amount or smells bad is a sign to go seek treatment.”

Image credit victormatara.


Diethylstilbestrol and Media Coverage of the “Morning After” Pill


The Food and Drug Administration (FDA) approves numerous prescription medicines everyday. The public consumes them, because they believe that these drugs will be safe and effective. We know that not all drugs are one hundred percent free of risks from other side effects, but we consume them because the FDA has judged them to be safe. There are times when the FDA does not approve the safety of high-demand drugs quickly enough to please the public and the companies that would like to manufacture the medicines. One example of such a situation involves the “morning after” pill. As a result of public demand, the media has pressured the FDA to speed up the approval of Diethylstilbestrol (DES) for use as a “morning after” pill. The misleading, inaccurate, and incomplete information about the “morning after” pill as delivered by journalists has deceived members of the public and has caused them to put even more pressure on the FDA. This pressure may cause the FDA to give less careful consideration to the risks associated with the disease and may ultimately harm many women’s health. The popularity of DES in 1970s resulted in tragic outbreaks of cancer in both the users of the drug and their children. By presenting only the benefits of DES, the media jeopardizes the health of many more in the future.


The news media is a powerful force. It has extensive power because it chooses what stories to deliver and how to present them. Reporters and journalists usually provide reliable information about the weather, sports events, and accidental deaths. However, media coverage of new drugs and medicines is not always as complete and accurate as it should be given the tremendous impact that these stories have on public health.

One example of this is recent coverage of the “morning after” pill. News reporters have delivered the message that the “morning after” pill is a safe and effective postcoital contraceptive that prevents pregnancy after unprotected intercourse. The “morning after” pill contains Diethylstilbestrol (DES), a form of synthetic estrogen that does not contain steroids. DES was introduced in Europe in the 1940s and was believed to be an effective way of preventing pregnancy when other contraceptive methods, such as condoms, fail. DES could also be used in cases of rape. Although the U.S. Food and Drug Administration (FDA) had approved the usage of DES for treatments of breast cancer and osteoporosis, it has never approved its prescription as a contraceptive because of safety concerns. Recent media coverage of the “morning after” pill downplayed these concerns and instead presented the drug as a safe and effective contraceptive that the FDA is reluctant to approve for social rather than medical reasons. News reports described how widespread use of the pill in Europe had lowered the rate of abortions. They included reports of American doctors who believe so strongly in the effectiveness of the “morning after” pill that they prescribe DES for this purpose despite the lack of FDA approval. Reporters interviewed users who claimed that the pill is a miracle. Because of this one-sided coverage, the American public has begun to pressure the FDA to approve DES as a “morning after” pill. The misleading, inaccurate, and incomplete information presented by the media about the “morning after” pill has deceived the public and, if the FDA gives in to public pressure, may ultimately jeopardize the health of millions of women in this country.


Most Americans do not realize how much money and time is required to certify the safety and effectiveness of a new drug. According to Psychopharmacology Update, on the average, a company spends a total of $359 million during the typical fifteen year long drug approval process. The process begins in the laboratory and ends at the pharmacist’s counter. This process involves many steps. The new drug must be examined in the laboratory and must later be tested on animals in order to make sure that it will have no unexpected results when it is introduced into a complex biological system.  After the compound is proven to be safe in animals, the company then files an Investigational New Drug Application (IND) with the FDA. The FDA has thirty days to disapprove the application; otherwise, it automatically becomes effective. The IND includes the results of the experiments:

How, where and by whom the studies [on humans] will be conducted; the chemical structure of the compound; and how it [is] thought to work in the [human] body; [suggestion of] any toxicity found in the animals studies; and how the compound is manufactured.

After the FDA approves the IND, the company will begin to test the drug on humans. These tests are divided into three phases of clinical trials. Phase I studies how the drug is absorbed, distributed, metabolized and excreted and generally involves twenty to eighty healthy volunteers. This phase also establishes the correct dosage. Phase Il studies the drug’s effectiveness on approximately 100 to 300 people. Phase III studies adverse reactions and involves more than three thousand patients in hospitals and clinics. If these tests show favorable results, the company analyzes the data and files a New Drug Application with the FDA. The New Drug Application must include all scientific information that has been gathered, and it is usually more than one hundred thousand pages in length. The FDA reviews the New Drug Application for a minimum of six months, but most drug approvals take more than nineteen months.


Many Americans complain that the FDA takes ·too long to certify new drugs. By the time a drug has been officially recognized, some people with the targeted disease may have already died. European nations typically approve drugs faster than the United States. This handicaps American companies that must compete against European drug manufacturers. Intense pressure from these companies and the general public has made the FDA realize that it needs to consider changes to its review process. The FDA has also faced criticism from people like Dr. Jean Paul Gagnon, a director of global economic policy at Marion Merrel Dow, Inc. in Kansas City, who says,

They [the FDA] are very slow and plodding. They have no vested interest in expediting the drug approval process. Bureaucrats fear they might lose their job if they approve something that backfires.

Gagnon suggests that we should hire other experts who will approve drugs quicker than the FDA. He argues that the FDA is currently “overwhelmed, understaffed, has no organization efficiency, and no real incentive to speed up the approval process.” In 1995 the FDA had responded to criticism of this sort by hiring an additional three hundred staffers to review new drugs and medical technologies. The FDA also plans to hire another three hundred staffers in order to further increase the speed of the approval process.

According to FDA Consumer, the FDA has implemented four initiatives that would accelerate the approval process. One initiative shortens the approval process for “breakthrough” drugs. The second initiative gives priority consideration to drugs which could treat more serious diseases such as cancer and Alzheimers. A third initiative allows the FDA to accept results from animal drug testing that has been conducted in other countries. This initiative has the added benefit of reducing the total amount of animal testing in the world. The fourth initiative allows the FDA to hire outside experts to “review certain routine applications for new drugs and biological materials.” David Kessler, the chairman of the FDA, claims that these four initiatives will reduce the entire drug-approval process from the original length of fifteen years to about ten years.


There are several reasons that the FDA has not yet approved the “morning after” pill. First, the need for this drug is not as pressing as the need for treatments for diseases such as cancer and AIDS. Thousands of Americans have died from AIDS and no reliable treatments have been found. Millions of Americans who have contracted HIV will gladly experiment on their own to prove the effectiveness of certain drugs, and because their disease is life-threatening, there is a feeling that they should be allowed to try untested drugs despite the risk of side-effects. Postcoital contraceptives such as the “morning after” pill are in demand as a way to reduce the abortion rate by preventing eggs from implanting in the uterus. But many Americans believe that the use of birth control pills, especially those like the “morning after” pill which prevents contraception after intercourse, is immoral. As a result, there is less public support for the approval of this drug than for other drugs. In addition to these factors, the side-effects and long term consequences of the use of DES as a contraceptive are not yet well understood. While some treatments involving DES seem to be safe and effective, harmful long term consequences such as cancer have been linked to other uses of DES.

One example of a positive use of DES is as a treatment of postmenopausal osteoporosis. According to Health journal, Eli Lilly filed a new drug application in 1996 asking for permission to market Raloxifene to treat this condition. The company did experiments in clinics on twelve hundred postmenopausal women ·from the ages of forty-five to sixty-five. Seventy-five percent took Raloxifene and twenty-five percent took a placebo. The study found that women who took Raloxifene increased their bone density by an average of two to three percent, while those who took the placebo lost bone density. The study also showed that the drug can be used to fight the number one killer in America – heart disease. Raloxifene is now proving its effectiveness in 7,700 women aged sixty to seventy in over twenty countries worldwide. Side effects, such as blood clots in the legs, hot flashes, et cetera, occurred more frequently among those who took the placebo than among those who took the -drug. The quest for a cure for osteoporosis may be over. Many treatments for osteoporosis increase the risk of breast cancer, but Raloxifene does not seem to do so. Ethel Siris, director of the osteoporosis program at Columbia-Presbyterian Medical Center in New York, stated that “Raloxifene will give you a bone benefit that’s quite substantial … it’s going to lower bad cholesterol, raise good cholesterol, though not as much – but it’s going to do nothing to the uterus. You won’t bleed or have malignant changes, and it does not create breast problems.” Raloxifene has been on the market as of January 1998 under the brand name Evista. In addition to Evista, many other drugs used to treat osteoporosis contain 0.625mg of estrogen (in the form of DES), “which helps to prevent menopausal symptoms and helps keep women’s hearts healthy.” For the “morning after” pill to be effective, it must be taken for three to five days after intercourse. This is a very short period of time compared with the several years of use required for the treatment of osteoporosis.

Millions of women increase the estrogen [or a drug containing an estrogen substitute] in their bodies when they take oral contraceptives or pills to relieve symptoms associated with menopause, such as hot flashes, sweating, and vaginal dryness.

The FDA had long since approved many drugs like Premarin, Ogen, and Estrace to treat women and men who suffer from osteoporosis before putting DES on the market as a postcoital contraceptive that is only for emergency use. Droloxifene, Idoloxifene and GW5638 are currently undergoing clinical trials to test their effectiveness in treating both osteoporosis and breast cancer patients. It will be several years before these drugs are proven safe and are available to patients who currently suffer from osteoporosis and breast cancer.

In 1997, the American Public Health Association formally protested the slowness of the FDA approval process for the “morning after” pill which had been pending for over two years. The FDA later endorsed the post’coital contraceptive, indicating that two tablets should be administered seventy-two hours after intercourse and two more in the next twelve hours. Six different brands of oral contraceptives containing ethinyl estradiol and norgestrel (protesgin) or levonorgestrel could be approved as a “morning after” pill. The FDA finally approved DES in the form of the “morning after” pill saying it is seventy-five percent effective and common side effects include nausea, vomiting, bleeding, and breast tenderness.


Diethylstilbestrol is a synthetic estrogen that was first introduced in 1938 by Professor E.C. Dodds in Europe. In the 1940s, European doctors tested the pill in one patient, which involved a dosage of 135mg per day for three weeks. It was observed that 150mg of the pill was excreted from the urine within twenty-four hours after ingestion. This quantity of estrogen intake is more than the natural amount of estrogen produced in the body. The findings concluded that DES, used in the prevention of miscarriages, is to be taken “30mg daily with the daily dosage increased by 5mg weekly through the 35th week.” To prevent miscarriages, the original indication administered a quantity that ranged from 135 to 18,200 mg of DES. In the early 1970s DES was found to cause cancer in animals. Despite the risk of cancer and other complications, doctors still prescribed DES to women around the world to prevent miscarriages throughout the 1970s.

In spite of the carcinogenicity of lower doses of DES and the FDA’s disapproval of DES as a “morning after” pill, about fifty percent of university health services and an unknown number of private physicians were prescribing the “morning after” pill to some two million women without explicit disclosure of its experimental status.

When it was finally established that this use of DES causes vaginal cancer, clear-cell adenocarcima to exposed daughters of women who used DES, possibly breast cancer to DES-using mothers, and prostate cancer to their sons, use of DES as a miscarriage prevention drug was banned from the market in the late 1970s. DES had also been prescribed to treat hormone deficiencies, menopause-related problems, advanced breast and prostate cancer, suppression of lactation, and as a postcoital contraceptive. DES is still being used for some of these purposes, but has been discontinued for others because women experienced long-term complications such as cancer-related illness that need to be scrutinized.

Some doctors used DES as a “morning after” pill in the late 1950s because estrogen stops the egg from implanting in the uterus. Some users publicized that it was the safest way to prevent unwanted pregnancies. The typical dose prescribed by doctors was two 25mg tablets each day for five days. This contained about 500 times the amount of estrogen the body naturally produced. The Planned Parenthood group surveyed two hundred women in Sacramento Valley to publicize the “morning after” pill usage. About thirty percent of the women knew the pill existed but they knew very little about the side effects. They just knew the drug was the way to avoid unintended pregnancy. Some users, particularly teenagers constantly overused the pills, thereby increasing the risk of negative long term consequences.

It was later revealed that some of the early tests indicating the safe use of DES as a “morning after” pill had incorporated false data. One university, “in the October 1971 Journal of the American Medical Association, [stated] that DES had proved one hundred percent effective as a postcoital contraceptive in 1000 women exposed to unprotected intercourse.” The National Institute of Health later discovered that some pregnancies had been excluded in the final report to make the drug appear to be a better postcoital contraceptive than it is. Only two years later, in 1973, the “FDA approved labeling for the first and only time for a “morning after” pill – a regimen of the estrogen diethylstilbestrol, or DES.” The public believed that DES used as a “morning after” pill would likely reduce the high numbers of abortions; therefore the members of the FDA approved the drug even though they had misgivings about its safety and effectiveness.


DES was generally believed to be the safest and most natural estrogen replacement back in the 1950s. The public did not know what to believe because they knew very little about the new drugs or their side effects. But journalists delivered an incomplete message about DES; continuing to assure people of the effectiveness of DES as a “morning after” pill even after it was suspected that there were serious side effects. This caused the public to push the FDA to approve the drug despite the dangers. This one-sided reporting may therefore indirectly endanger the health of many women. According to Deni Elliot’s Foundations for News Media Responsibility, most people define journalists’ special job as to tell the public the truth, get the story at all costs, be accurate about their sources, and speak for the downtrodden. Journalists do a good job of reporting the obvious news such as the drug examination done by the FDA and report when the drugs are placed on the markets. However, journalists do a very poor job of reporting complete stories. The information journalists deliver to the public is brief and broad; important details such as the serious side effects of DES are incompletely covered. USA Today submitted an article entitled “‘Morning After’ Pill Receives FDA Backing.” The author reported that the “morning after” pill is supported by the FDA, is seventy-five percent effective; and is used when other methods fail. The author concluded that “it can cause side effects: nausea and vomiting.” The same message was delivered by Women Health Weekly, which stated “nausea and vomiting are common side effects” for the “morning after” pill. Both discuss the safety of the “morning after” pill by stating that if the FDA approved it, it must be okay. A woman who takes the “morning after” pill will experience only nausea and possibly vomiting for now, but what will she experience ten years from the day she takes it? Does anyone mention that it causes abdominal pain, cramps, headaches, dizziness, and menstrual irregularities? In addition, the first dose may make her vomit repeatedly so that she can not consume the second dose or the following doses. Yet, Public Health Reports stated only that “risks, contraindications, and warnings are the same as for contraceptive drugs prescribed for daily use.” The New York Times described the side effects of the “morning after” pill as “considerably less unpleasant than [other] birth-control pills used for the same purpose.” The author continued, “The failure rate is virtually nonexistent. And the method is simpler, because a woman needs only a single dose.”

The author proclaims its one hundred percent effectiveness: no chance of failures. But according to the actual statistics, the “morning after” pill has a twenty-five percent chance of failure, and both these and the other seventy-five percent of the women may become seriously ill in the future as a result of taking the drug. Another article from The Record, Hackensack, N.J. had comparatively good coverage; it listed the side effects which “include nausea, vomiting, menstrual irregularities, breast tenderness, headaches, abdominal
pain, and dizziness.” It did a great job reporting the short-term effects; however, no long-term effects are mentioned.

In order for many postcoital contraceptives to be effective and work correctly, a woman has to keep track of the doses; that is, if she misses· one pill of the dose, she could risk becoming pregnant. If she is changes her mind and does not complete the cycle of medications, then chances are that she will deliver a child who will later suffer from problems like reproductive abnormalities and certain types of cancer. It is likely that most women will find the “morning after” pill ineffective because the whole process takes five days, which is very long considering the potentially serious side effects when each dose is ingested. Moreover, about eighty percent of women who were treated (with the “morning after” pill) were not pregnant in the first place. A woman who is not pregnant is taking a completely a unnecessary risk, a risk made worse by the high dose of estrogen. To quote Cynthia Laitman Orenberg’s book entitled DES: The Complete Story:

Two physicians from the University of Washington reported in the March 6, 1980, issue of the New England Journal of Medicine that women who use estrogenic oral contraceptives run a nearly 7 ~ times greater risk of developing endometrial cancer than nonusers. Of some comfort is that the incidence of endometrial cancer is lower in women who use oral contraceptives containing mostly progesterone-like hormones (synthetic progesterones) rather than estrogen.

Most prescription drugs which contain estrogen do so in small amounts. Over the course of the five day course of medication, the “morning after” pill delivers a large amount of estrogen. The monthly update of Facts and Comparison reported many problems regarding the use of estrogen in treating other diseases. The problems range from serious cancer to minor nausea. Drugs containing estrogen have been used to treat thromboembolic disease but result in a high risk of secondary diseases. The risks include thromboembolic and thrombolic vascular diseases, which are also known as thrombophlebitis, pulmonary embolism, stroke and myocardial infarction. Retinal and mesenteric thrombolism and optic neuritis have been reported recently. Estrogen is used to treat breast and prostate cancer, but it can cause hypercalcemia. Side effects like breast cancer, estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding have been reported in many uses of estrogen. High doses caused

edema (abnormal water retention) in the lining of the uterus … [which] create an inhospitable environment for the implantation of a fertilized egg … About one out of every 200 women who take DES as a postcoital contraceptive will become pregnant despite treatment.

It seemed reasonable that drugs which contain lesser amounts of estrogen are better; this is why the FDA approved Estratab’s 0.3mg pill for treatment of osteoporosis. It is unknown at this time if this lower dosage of estrogen will be safe.


The use of DES in the treatment of osteoporosis as well as other diseases may seem to be absolutely safe, but is far from risk-free. This is why the responsibility of journalists to tell the public the true story is so crucial; it affects women’s decisions about their health. Although experts recognize the controversy in our society about drugs, to ensure that everyone understands the risks of treatments, journalists as well as the media need to report the whole and complete story, not just part of the news. They must not be biased or side with any one source. They need to report the differences to allow the public to make informed choices. The use of the “morning after” pill is dangerous because the long-term effects are not clear. Because of these longterm effects, journalists must not jump to conclusions in which they pressure the FDA to make wrong decisions. These decisions may influence the safety of the American public. Because the media has limited time and space to report news, it needs to deliver either the complete story or deliver nothing. The tragedy of daughters and sons who discovered they have cancer after their mothers ingested DES twenty years ago demands that these facts be told.


  • Download the PDF : Diethylstilbestrol and Media Coverage of the “Morning After” Pill, Indiana University, DIANE-DINH KIM Luu, 1999.

Contraception – the morning after

A former postcoital contraceptive was diethylstilbestrol (DES) which has been linked to cancer in the daughters of women who had taken the drug to prevent miscarriage


Although no postcoital method has been developed for safe and effective regular use, postcoital contraception is being offered in Canada and Western Europe on an emergency basis to people who experience such problems as a burst condom. It is little known in the US, however. The 1st commercial version of a postcoital method recently became available to women in England.

The first reference in the medical literature to the use of postcoital contraceptives appeared in a 1966 article by John Morris and Gertrude van Wagenen of the Yale University School of Medicine. The drug referred to was diethylstilbestrol (DES), given in doses of 50 mg daily for five days following unprotected intercourse. Although this treatment produced several immediate side effects, including nausea or vomiting in most patients, trials showed that only about one percent of women who took it became pregnant.

DES was used for more than a decade as a postcoital contraceptive, and it was even endorsed by the U. S. Food and Drug Administration (FDA) in 1975 for use by rape victims. Many people questioned the FDA’s action because DES had been linked to cancer in the daughters of women who had taken the drug to prevent miscarriage.

A new postcoital contraceptive regime was developed by Albert Yuzpe and consists of 4 ordinary contraceptive pills combining estrogen and progestin to be taken over a 12-hour period. In the US, this is the formulaion of birth control pill marketed under the trade name Ovral by Wyeth Laboratories. England and Germany are the only countries in which the Yuzpe method is officially approved for use as an emergency postocital contraceptive, but the method is used to some degree in most European countries, being well-known in France and Denmark. The most frequent side-effect reported by Yuzpe is vomiting experienced by 29% of women; another 22% felt nauseated. Other side effects, e.g. headache, were infrequent. The findings of the Pregnancy Advisory Service and the Brook Advisory Centre in Britain are reported. Overall very few side effects were found. Postcoital contraceptive treatment may cause the length of the cycle in which it occurs to be irregular. Treatment before day 15 has been found to shorten the cycle, whereas treatment after day 15 lengthens it. The majority of women who become pregnant due to treatment failure tend to seek an abortion. Ectopic pregnancy incidence may also be a result of treatment failure. In 1981, the International Planned Parenthood Federation (IPPF) issued a statement endorsing the use of postcoital contraceptives. Reasons for using them include rape, problems with barrier methods, ineffective use of the pill and IUD expulsion. No drug company in the US has expressed interest in getting FDA approval to market a postcoital contraceptive, partly because its usage might not be widespread. Opposition to approval from groups who believe life begins at conception and consequently that postcoital contraceptives are an abortifacient is expected.


  • Contraception–the morning after, Family planning perspectives, NCBI PubMed PMID: 6519238, 1984 Nov-Dec.
  • Image credit someecards.

Postcoital Diethylstilbestrol

FDA Drug Bulletin, May 1973

IN AGREEMENT WITH ITS extragovernmental physician-advisers, FDA has approved, under restricted conditions, postcoital (contraceptive) use of diethylstilbestrol (DES), a synthetic estrogen.

Adequate evidence to support the use of any other estrogen for this purpose is not presently available.

The Agency considers the use of DES for this purpose to be safe only as an emergency measure (in situations such as rape, incest, or where, in the physician’s judgment, the patient’s physical or mental well-being is in jeopardy) and explicitly warns against its routine or frequent use as a contraceptive.

Physicians are urged, prior to prescribing DES for this purpose, to inform patients (or guardians) fully of the possible side effects of the drug, and of alternative measures available and their hazards, so that the patient may participate in an informed way in the decision to use the drug. Pregnancy should be ruled out by appropriate tests prior to instituting therapy, so that no unnecessary exposure of a fetus to DES occurs.

The efficacy of DES in preventing pregnancy depends upon the time-lapse after coitus and dosage of the drug. The currently recommended dosage is 25 mg twice a day for 5 continuous days beginning, preferably, within 24 hours and not later than 72 hours after exposure. When this dosage is given within the specified time interval after sexual intercourse, DES is highly effective in preventing conception. But the patient must be warned to take the full course of the drug in spite of the nausea which commonly occurs, if it is to be effective.

There is at present no positive evidence that the restricted postcoital use of DES carries a significant carcinogenic risk either to the mother or fetus. However, because existing data support the possibility of delayed appearance of carcinoma in females whose mothers have been given DES later in pregnancy, and because teratogenic and other adverse effects on the fetus with the very early administration recommended are ill understood, failure of postcoital treatment with DES deserves serious consideration of voluntary termination of pregnancy.

Before prescribing, the physician should be familiar with the complete FDA-approved labeling on products intended for this use.

More Information – Abstract from WikiVisually

  • In May 1973, in an attempt to restrict off-label use of DES as a postcoital contraceptive to emergency situations such as rape, a FDA Drug Bulletin was sent to all U.S. physicians and pharmacists that said the FDA had approved, under restricted conditions, postcoital contraceptive use of DES. (In February 1975, the FDA Commissioner testified that the only error in the May 1973 FDA Drug Bulletin was that the FDA had not approved postcoital contraceptive use of DES.)
  • In September 1973, the FDA published a proposed rule specifying patient labeling and special packaging requirements for any manufacturer seeking FDA approval to market DES as a postcoital contraceptive, inviting manufacturers to submit abbreviated new drug applications (ANDAs) for that indication, and notifying manufacturers that the FDA intended to order the withdrawal of DES 25 mg tablets (which were being used off-label as postcoital contraceptives).
  • In February 1975, the FDA said it had not yet approved DES as a postcoital contraceptive, but would after March 8, 1975 permit marketing of DES for that indication in emergency situations such as rape or incest if a manufacturer obtained an approved ANDA that provided patient labeling and special packaging as set out in a FDA final rule published in February 1975. To discourage off-label use of DES as a postcoital contraceptive, in February 1975 the FDA ordered DES 25 mg (and higher) tablets removed from the market and ordered the labeling of lower doses (5 mg and lower) of DES still approved for other indications be changed to state: “THIS DRUG PRODUCT SHOULD NOT BE USED AS A POSTCOITAL CONTRACEPTIVE” in block capital letters on the first line of the physician prescribing information package insert and in a prominent and conspicuous location of the container and carton label.
  • In March 1978, a FDA Drug Bulletin was sent to all U.S. physicians and pharmacists which said: “FDA has not yet given approval for any manufacturer to market DES as a postcoital contraceptive. The Agency, however, will approve this indication for emergency situations such as rape or incest if a manufacturer provides patient labeling and special packaging. To discourage ‘morning after’ use of DES without patient labeling, FDA has removed from the market the 25 mg tablets of DES, formerly used for this purpose“.


  • Selected Items, from the FDA Drug Bulletin, California Medicine, NCBI PubMed PMC1455105, May 1973.
  • Emergency contraception, DES, wikivisually.

Pioneering Studies of the “Morning-After” Pill

Drs Morris and van Wagenen tested Diethylstilbestrol usage for years

2011 Abstracts

Yale School of Medicine produced the first proof-of-concept study on the viability of a “morning-after” pill for human use. This study was a result of a fruitful collaboration between a pair of Yale scientists, Drs. John M. Morris and Gertrude van Wagenen, who sought a non-abortion, post-coital contraceptive. They tested a variety of hormones, hormone-based synthetic drugs, and other compounds in monkeys in an effort to uncover a compound that was non-toxic but highly effective. Unfortunately, although they were unable to identify such a drug, their initial studies inspired other scientists to further pursue the concept of a “morning-after” pill, leading to the development of Food and Drug Administration (FDA)-approved emergency contraceptives.

… “Morris and van Wagenen had shown that diethylstilbestrol, ethinyl estradiol, and mestranol prevented implantation in rabbits very efficiently. These same compounds were ineffective in preventing implantation in monkeys at the same dosage, but when the concentration was increased and treatment given orally or by intramuscular injection for 6 days, they were able to prevent ovum implantation. This set the stage for a preliminary clinical trial that showed that 50 mg of diethylstilbestrol or 0.5 mg of ethinyl estradiol for 4 to 6 days after coitus was effective in preventing pregnancy. Though this study was not statistically significant, it represented the first time that prevention of implantation was demonstrated in humans.

Unfortunately, diethylstilbestrol and ethinyl estradiol have several side effects, such as nausea and breast soreness, which are common to estrogenic compounds. An ideal post-coital contraceptive would be non-toxic, non-teratogenic, highly effective against implantation of the ovum, and exhibit few side effects. In an effort to find such compounds, Morris and van Wagenen turned to … ” …


  • Pioneering Studies of the “Morning-After” Pill, The Yale journal of biology and medicine, NCBI PubMed PMCID: PMC3117403, 2011 Jun.
  • Image credit villagevoice.

Interception : the use of postovulatory estrogens to prevent implantation

In the 60s and 70s, Morris and van Wagenen tested how diethylstilbestrol could prevent implantation in macaque monkeys


…”Nonetheless, clinical experience has been encouraging in both reported and unreported series of cases. To quote Haspels,’

“The administration of large doses of estrogen to 2,000 women during the first five days after unprotected intercourse is found to be effective in reducing the incidence of pregnancy to a very low level.”

Failures have been in most instances related to errors in timing or inadequate dosage of estrogen. Compounds that have been used in women include diethylstilbestrol, 25 to 50 mg. per day; diethylstilbestrol diphosphate (Stilphostrol*) , 50 mg. per day; ethinyl estradiol, 1 to 5 mg. per day : and conjugated estrogens (Premarinf ), 20 to 25 mg. per day. “…

…”Based on the macaque studies, stilbestrol given in a dose of 50 mg. per day for 6 days en in a dose of 50 mg. per day for 6 days should be an effective interceptive, or a total dose of approximately 200 to 300 mg. for the average woman. Of 15 women who became pregnant after postcoital stilbestrol or stilbestrol diphosphate, 8 received total doses of 30 to 150 mg. Several of these involved multiple exposures and questions of timing as well. In 7 receiving 250 mg., there were 2 treated on the twenty-second and twenty-ninth days of the cycle, and 2 had multiple exposures and the time of ovulation was uncertain. In 3 patients, the dosage (250 mg.) and timing seemed correct, and they must be listed as method failures.”…

…”Only one case involving a serious side effect has been observed, SchumacheF at Miami University reported a student who developed findings compatible with acute pulmonary edema after 3 doses of stilbestrol (50 mg. per day). She had given a history of fluid retention prior to her period. With oxygen and supportive therapy, the chest cleared completely within 36 hours.”…


  • Interception: the use of postovulatory estrogens to prevent implantation, American journal of obstetrics and gynecology, NCBI PubMed PMID: 4628937, 1973 Jan.
  • Image credit Jonathan Forage.

Compounds interfering with ovum implantation and development – The role of estrogens

Though this study was not statistically significant, it represented the first time that prevention of implantation was demonstrated – with DES usage – in humans


“It has been known for many years that estrogens interfere with early pregnancy in the rabbit and other specics.”…

…”In spite of evidence that success in the macaque should be paralleled by success in man, initial human experimentation was undertaken with some trepidation.

The first cases were rape cases. All of the subjects received 50 mg. of stilbestrol for 4 to 6 days after exposure. The chance of pregnancy following rape is uncertain for many obvious reasons. Sometimes no sperm could be found in the cervix or vagina. In a few instances, temperature charts were started; if no rise occurred, no drug was given. In most of the cases accepted for treatment, exposure occurred near midcycle and fern crystallization of cervical mucus as well as presence of sperm were demonstrated. In this small series of patients, none has become pregnant so far. The subsequent menstruation was generally unremarkable, although in some instances it was either scantier or more profuse or prolonged than usual. Side effects, when they occurred, were those usually associated with administration of estrogen; they consisted of nausea and breast soreness, which ceased shortly after medication was stopped.

A limited number of courageous volunteers furnished an opportunity for further and more adequate observation. Coitus took place at midcycle near the time of the temperature rise. Fern crystallization and Huhner tests with motile sperm were obtained
in most instances.

The apparent effect of 5 to 50 mg. of stilbestrol or 0.5 mg. of ethinyl estradiol on the biphasic temperature curve chart is to counteract the thermogenic effect of progesterone or to shorten the luteal phase.

From these charts it was anticipated that the secretory changes in the endometrium might be altered. However, instead of a proliferative or hyperplastic endometrium, endometrial biopsies taken on postovulation days 5 to 7 and 10 to 12 showed a progestational effect with secretion in some instances on both sides of the nucleus, occasionally almost suggestive of an Arias-Stella reaction. The stroma was dense in some areas, markedly edematous in others. Basal vacuolization often persisted up to menstruation, sometirnes giving an early secretory appearance late in the cycle.

In these preliminary trials there have been no pregnancies. While of interest, these clinical studies are incomplete and have as yet no statistical significance.” …


  • Compounds interfering with ovum implantation and development. 3. The role of estrogens, American journal of obstetrics and gynecology, NCBI PubMed PMID: 4959099, 1966 Nov.
  • Image credit thinglink.

Expanding access to emergency contraception in developing countries

Emergency contraception has been called the best-kept contraceptive secret

1995 Abstract

Previous research shows that several regimens of postcoital contraception offer safe and effective ways for women to avoid pregnancy. Yet the methods are typically unavailable to women in developing countries. In this article, the authors review the main methods of emergency contraception and describe experience with them to date. The prevalence and urgency of the need for making these methods available to women in developing countries are assessed. The necessary elements for creating such access are described. In several developing countries, conditions for introducing the methods may be more favorable than in industrialized countries. These advantages are reviewed. Finally, the authors describe the challenges anticipated for broadening the availability of postcoital methods in the developing world. They conclude with a brief series of recommendations for policymakers.


In the order of the amount of research available on each, five regimens of emergency contraception are reviewed:

  1. the estrogen/progestin combination of ethinyl estradiol and levonorgestrel, known as the Yuzpe regimen;
  2. the copper IUD;
  3. levonorgestrel-only regimens;
  4. danazol, a synthetic steroid;
  5. and mifepristone, also known as RU-486, a progesterone antagonist that appears to work well as a postcoital contraceptive.

The Yuzpe regimen was discovered more than 20 years ago, and it consists of 200 mcg of ethinyl estradiol and 1.0 mg of levonorgestrel taken 12 hours apart and initiated within 72 hours of unprotected intercourse.

In the late 1970s, Lippes discovered that copper-bearing IUDs could prevent pregnancy when inserted within 5 days after intercourse. This method may even be effective for up to 7 or 10 days postcoitally. Studies have confirmed that the IUD method had a failure rate of less than 0.1%.

The levonorgestrel regimen requires the taking of 1.5 mg levonorgestrel divided into two doses 12 hours apart and initiated within 48 hours of unprotected intercourse. Tablets containing 0.75 mg of levonorgestrel are marketed for infrequent intercourse to be taken immediately after intercourse. Postinor, marketed by Gedeon Richter of Hungary, is registered in eastern European countries and some developing countries.

The synthetic steroid danazol produces fewer side effects than the Yuzpe regimen. 600 mg of danazol has to be taken within 72 hours after unprotected intercourse and another 600 mg taken 12 hours later.

The RU-486 regimen consists of a single 600 mg dose postcoitally within 72 hours of unprotected intercourse.

A variety of other regimens, including ethinyl estradiol, conjugated estrogens, diethylstilbestrol, and quingestanol acetate have also been studied for use as postcoital contraceptives.

The prevalence of need in developing countries depends on conditions for use and potential users. The urgency of need (unintended pregnancies, social conditions, age, and cost), expanding access, challenges to expansion, and some recommendations are also discussed.


  • Expanding access to emergency contraception in developing countries, Studies in family planning, NCBI PubMed PMID: 8571440, 1995 Sep-Oct;.
  • Image credit becominghuman.