Dr. Rebecca Gomperts hopes healthcare providers can eventually “move flexibly between [mifepristone’s] different indications: as a weekly contraceptive, as an on-demand method used before or after sexual intercourse, or as an early medical abortion method.”
For decades, research has indicated that mifepristone may be a safe and effective contraceptive, but no one has conducted a large clinical trial to produce the evidence required to form the basis for government approval of the drug for this use—until now.
Pioneering reproductive health advocate Dr. Rebecca Gomperts announced on Dec. 24 preliminary results of a large clinical trial in Moldova showing that a 50 mg dose of mifepristone is very effective as a weekly contraceptive pill.
“The outcome so far is beyond expectations,” said Gomperts. “Of the 2,000 cycles with unprotected intercourse, there was only one pregnancy—and that participant was already pregnant before she started using the medication.”
Women on Waves, founded by Gomperts, convened an international team of experienced medical, scientific and ethics professionals to work with the Stockholm-based medical university, Karolinska Institutet and the Leiden University Medical Center (LUMC) in the Netherlands to conduct the clinical trials in compliance with all the requirements of the European Medicine Agency and the U.S. Food and Drug Administration.
Only 4 percent of the 550 participants reported side effects, which were minor: Two percent had headaches and another 2 percent had hot flashes. Compare that to the 40 percent of people using hormonal contraceptives who complain of side effects, said Gomperts.
“This method does not have the contraindications or side effects associated with the estrogens and progestins in hormonal contraceptives, such as weight gain, loss of libido or feelings of depression,” said Gomperts. “It also does not have the increased risk of breast cancer and thrombosis with use of hormonal contraceptives.”
An added benefit is that mifepristone is easier to use and more reliable than hormonal contraceptives. Whereas most traditional hormonal contraceptives must be taken daily, often at a particular time, mifepristone may be used more flexibly.
“When you forget the hormonal pill one day, it doesn’t work anymore. If you forget mifepristone one day and you use it the next day or the day after, it will still work. The function still is there and it takes a little bit of time to wear off,” said Gomperts.
In order for a fertilized egg to implant, it needs to have a really nice, fluffy endometrium. What mifepristone does is block the hormones that make that happen by blocking the progesterone receptor, so the endometrium doesn’t mature in the way that would make it possible for a fertilized egg to implant.
Dr. Rebecca Gomperts
Use of mifepristone can be tailored to frequency of sex. “Some people don’t want to use a pill every day when they only have sex once a week,” said Gomperts. “If you have a lot of sex, you use it once a week. If you have sex once every two or three weeks, you just use it when you have sex before or as a morning-after pill.”
Gomperts explained that hormonal contraception works by stopping ovulation, whereas mifepristone works through a combination of reducing the ovulation rate and preventing the build-up of the endometrium, the tissue that grows in the uterus during each menstrual cycle and is shed monthly as menstrual blood.
Eighty-nine (89) percent of the participants in the study stopped menstruating, which Gomperts described as “a positive side effect” for many people. “They prefer not to menstruate.”
Gomperts explained: “In order for a fertilized egg to implant, it needs to have a really nice, fluffy endometrium. What mifepristone does is block the hormones that make that happen by blocking the progesterone receptor, so the endometrium doesn’t mature in the way that would make it possible for a fertilized egg to implant.”
The clinical trials of mifepristone for contraception will expand to the Netherlands in the coming months. If the Netherland study is positive, Gomperts plans to apply to the European Medicines Agency for registration and market authorization of 50mg of mifepristone as a weekly contraceptive, which would allow use of the drug throughout the European Union.
“We hope we will have the study results within three years,” said Gomperts. “It can go pretty quickly after that because we already asked for advice from the European Medicines Agency to know what they require.”
Gomperts noted that she is not seeking approval for a new drug, but only a new indication for a drug that has been on the market for over four decades and has a strong safety record.
Many countries have already approved 200 mg of mifepristone, in combination with misoprostol, for abortion. Some, including Moldova, have approved mifepristone for treatment of myoma. In the U.S., the FDA has approved mifepristone to treat Cushing’s syndrome at a much higher dose of 600 mcg per day, which has been shown to be safe.
Gomperts notes that approval of mifepristone for contraception would make it available as a morning-after pill for use within 120 hours (five days) after unprotected intercourse.
“It would allow us to move flexibly between the medicine’s different indications as a weekly contraceptive, as an on-demand method used before or after sexual intercourse, or as an early medical abortion method, depending on life circumstances,” said Gomperts.
Whereas many in the abortion rights movement have sought to maintain a clear distinction between contraception and abortion, antiabortion advocates have tried to blur the line between the two, arguing that emergency contraception and even hormonal contraceptives are abortifacients.
“There has never been a clear distinction between contraception and abortion,” said Gomperts, noting that people disagree about when pregnancy starts—at fertilization, implantation or beyond. “This is such an artificial dichotomy that has no real meaning at all. There shouldn’t be a hard line. Abortion is not a bad thing. It’s good that it’s there and people can have it, because what matters is that people don’t get children they don’t want.”
Gomperts said they are also looking for a company that will agree to distribute mifepristone for contraception at an affordable price. “This is not a study where the results are protected by patents. It will all be open source because we want it to be cheap.”
Gomperts plans to work with the World Health Organization to make a mifepristone contraceptive available in low and middle income countries as well.
“We are registering it in the Netherlands so that we can use those data to get it registered immediately everywhere,” said Gomperts. “Mifepristone can fundamentally change the way women all over the world will be able to control their fertility.”
For approval in the United States, there would have to be clinical trials in the country, but Gomperts notes that clinicians could prescribe mifepristone off label for contraception once the evidence of its safety is published. Mifepristone is a good contraceptive alternative for people who can’t take hormonal contraceptives because they have had breast cancer or they have a high risk of thrombosis, said Gomperts. “It might be too long for them to wait for market authorization. I think we can already say now we know it’s safe. If they can find a gynecologist who is willing to prescribe them a 200 micrograms dose of mifepristone once a month, then they can just break it up in four and use it.”
Gomperts said the clinical trials of mifepristone for contraception is part of a larger effort to develop the full potential of mifepristone for many conditions, including fibroids and postpartum depression. “It works against endometriosis. It works against myoma. We are now involved in a study group that looks at whether it can prevent breast cancer. It has so many potential uses, but it hasn’t been developed. If we as women don’t make sure that it becomes available to meet our needs, then it won’t happen.”
You can support the clinical trials of mifepristone for contraception through GoFundMe.
