Ulipristal acetate, a common emergency contraceptive, could offer an alternative medication abortion regimen—but some experts warn that recent findings might fuel political efforts to restrict emergency contraception access.
Gynuity Health Projects has published new research in the New England Journal of Medicine suggesting that a double dose of ulipristal acetate (UPA), sold as an emergency contraceptive under the brand name Ella, taken in combination with the ulcer medication misoprostol, is an effective and acceptable medication abortion regimen with no reported serious adverse events.
The current recognized clinical standard for first-trimester outpatient abortion is mifepristone and misoprostol, but mifepristone is tightly restricted by the FDA. Ulipristal acetate, on the other hand, currently has no such restrictions.
“A major problem hindering use of medication abortion is availability. Increasing the number of methods and arsenal of options could have bold and transformative implications for potential users everywhere,” said Beverly Winikoff, the lead author of the paper and president of Gynuity Health Projects.
The Trump administration is threatening to restrict mifepristone further, including barring clinicians from providing the medication via telehealth and mail. Telehealth abortion first became available in 2021 and now comprises 20 percent of all abortions in the U.S., greatly expanding access, especially in rural areas.
A major problem hindering use of medication abortion is availability. Increasing the number of methods and arsenal of options could have bold and transformative implications for potential users everywhere.
Beverly Winikoff, lead author of the paper and president of Gynuity Health Projects
“An additional accessible and affordable method for medication abortion would be useful where access to mifepristone is restricted or its supply is interrupted,” said Winikoff, noting that ulipristal acetate is available over and behind the counter in many countries. “This would be helpful in addressing unmet need and inequities worldwide.”
Ulipristal acetate is available over the counter in 22 countries and behind the counter (pharmacist prescribed) in 34 countries, according to the European Consortium for Emergency Contraception. Mifepristone at a low dose (between 10 and 25 mg) is available by prescription for emergency contraception in five countries.
While misoprostol alone can be used for early abortion, it is less effective than when combined with mifepristone. The study is part of Gynuity Health Projects’s exploratory clinical research into existing medicines that might offer an improvement to a misoprostol-only regimen.
Ulipristal acetate has a similar molecular structure to mifepristone, which can also be used as an emergency contraceptive. Both are anti-progestins that can, at a low dose, delay ovulation by blocking the effects of progesterone, which is a key hormone responsible for triggering ovulation. At a higher dose, mifepristone blocks uterine receptors for the hormone progesterone that helps establish and continue a pregnancy.
The two-stage study was implemented by Gynuity Health Projects together with the National Autonomous University of Mexico and Mexico City Health Secretariat and performed in the outpatient clinic of a public maternal hospital in Mexico City.
Participants with pregnancies of up to 63 days swallowed two 30 mg pills of ulipristal acetate in-clinic and then self-administered 800 mcg of misoprostol 24 hours later, holding two pills in each cheek for 30 minutes before swallowing any remaining bits. Complete abortion occurred with the study regimen in 129 out of 133 (97 percent) participants, a success rate comparable to a mifepristone-misoprostol regimen.
“The regimen shows a high success rate with minimal need for additional care, supporting ulipristal’s potential for medication abortion when combined with misoprostol,” said Dr. María Laura García-Martínez, the principal investigator of the study in Mexico.
After taking ulipristal acetate and misoprostol, the most common side effects were chills, diarrhea and nausea. These side effects were transitory, easily managed, and often associated with misoprostol use. No serious adverse events were reported.
Overall satisfaction with the abortion process was high. Among the 133 participants questioned during the follow-up visit, 130 rated the treatment satisfactory or very satisfactory, 113 rated the pain level as acceptable or very acceptable and 121 said they would recommend the study regimen.
There is a risk that the findings of this study could be misapplied and used by politicians to try to restrict ulipristal for emergency contraception.
Dr. Dan Grossman, director of ANSIRH at the University of California San Francisco
“We are planning additional collaborative studies to gain further insights and explore broader applications of ulipristal in medication abortion,” said Gynuity in a press release.
Winikoff says that ulipristal acetate “gives us another option” and notes “it is good to have two resources that you can be sure are safe and effective.”
The director of Advancing New Standards in Reproductive Health (ANSIRH) at the University of California San Francisco, Dr. Dan Grossman, expressed caution, however. “The findings from the current study alone are insufficient to justify the use of ulipristal acetate in medication abortion outside of a research setting.” Dr. Grossman called for a larger trial, preferably one that compares the effectiveness with either the mifepristone–misoprostol or misoprostol-only regimen.
A doctor told Ms. that the possibility of using ulipristal acetate “seems very promising but the drawback is the cost.” Ulipristal acetate is currently packaged in a 30 mg dose, so patients would have to buy two doses for this regimen, which is more expensive than one dose of mifepristone. There is currently no generic ulipristal acetate on the market in the U.S. In addition, several studies have found that ulipristal acetate EC is not commonly stocked in pharmacies.
A Risky Innovation?
Some have expressed concern that this research could endanger access to Ella in the United States, and potentially also endanger the FDA-approved over-the-counter emergency contraception Plan B, made from the synthetic hormone levonorgestrel.
“I think it’s very likely that the opposition will weaponize this study and twist it around to restrict access to emergency contraception,” said Kelly Cleland, executive director of the America Society for Emergency Contraception. “We need to continue to innovate in a thoughtful way that acknowledges the context that we’re in.”
Dr. Grossman agreed: “There is a risk that the findings of this study could be misapplied and used by politicians to try to restrict ulipristal for emergency contraception.”
The FDA has approve Ella for use up to 5 days after unprotected sex, while Plan B is approved for up to 3 days. In addition, Ella may be more effective than Plan B for people with higher body mass indices.
“One of my colleagues in Iowa said to us, ‘we’re hanging on to EC with our lives’ because that’s all they can offer,” Cleland told Ms. “People can’t get abortions easily in Iowa or other restrictive states, so having access to EC is more critical than it’s ever been.”
“One of my colleagues in Iowa said to us, ‘we’re hanging on to [emergency contraception] with our lives’ because that’s all they can offer. …People can’t get abortions easily in Iowa or other restrictive states, so having access to EC is more critical than it’s ever been.”
Kelly Cleland, executive director of the America Society for Emergency Contraception
Cleland emphasized that one dose of Ella cannot cause an abortion. “Nothing about this study changes anything we know about emergency contraception. The 30 milligrams of ulipristal acetate that is in Ella works by delaying ovulation. There’s no reason to think that 30 milligrams of ulipristal acetate would cause an abortion. There’s great evidence that it can’t do that.”
Plan B cannot cause an abortion at any dosage level.
Ulipristal acetate is being used in some countries to treat uterine fibroids and is being studied for treatment of endometriosis, bleeding in IUD users and breast cancer prevention.
In response to the study, the European Consortium for Emergency Contraception emphasized that EC pills such as ulipristal acetate and levonorgestrel are different from medication abortion and that emergency contraceptive pills are essential for reproductive health and autonomy. They also anoted that the new study on use of ulipristal acetate and misoprostol for medication abortion is “small and preliminary” and “its aim is to explore the feasibility of this regimen.”
In response to criticisms, Winikoff said, “Let’s see what we can make of this. I really think that people are defensive when they should be inquisitive about how things can be done better if we have this drug that more people can get to.”
