In 2025, 65% of all clinician-provided abortions were medication abortions, most provided with mifepristone and misoprostol. Increasingly, mifepristone has been under attack. Like mifepristone, Ulipristal Acetate (UPA) is a selective progesterone receptor (PR) modulator with anti-progesterone effects. In the US, UPA is approved as emergency contraception and marketed as “Ella” in a 30 mg dose formulation. Unlike mifepristone, Ella is not restricted by the Risk Evaluation and Mitigation Strategy (REMS) program.
A recent proof-of-concept study demonstrated that through 63 days gestation, a 60 mg dose of UPA followed 24 hours later by 800 mcg of buccal misoprostol was 97% effective at inducing complete abortion and deemed ‘acceptable or highly acceptable’ by 98% of participants. An accompanying editorial suggested a randomized controlled trial is warranted. We believe more data are needed before such a trial can be attempted.
We propose a prospective, single-arm, open label 6-month pilot study to assess the feasibility of recruitment and retention of patients up to 77 days gestation, using UPA and misoprostol for abortion in the current US policy environment. We will swap UPA (60 mg) in place of mifepristone and otherwise maintain misoprostol dosing by gestational duration consistent with current standard of care. We will require ultrasound-determined measurement of gestational duration and confirmation of complete abortion by ultrasound or serum hCG testing. Metrics will include enrollment rate, time to enroll, reasons for declining participation, willingness to be randomized and retention rates. We will also measure efficacy, side effects, acceptability and cost.