Comparison of two doses of ulipristal acetate for medication abortion up to 63 days of gestation

Randomised, double-blind, placebo-controlled, parallel-group clinical trial to evaluate the efficacy of two regimens of ulipristal acetate in combination with misoprostol for medication abortion in women up to 63 days of gestation

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN40136678

Enrollment

426

Registered

2025-09-01

Start date

2025-10-01

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Termination of pregnancy (medication abortion) in women up to 63 days of gestation

Interventions

Intervention group (60 mg): Ulipristal acetate 60 mg orally (two 30 mg tablets) administered under direct supervision in clinic, followed 24 hours later by self-administered buccal misoprostol 800 mcg

in such cases, all prior allocations remain identical to the original scheme, and new allocations are generated in continuation of the same random sequence. The random allocation lists will be used to

Eligibility

Sex/Gender

Female

Age

18 Years to 52 Years

Inclusion criteria

Inclusion criteria: 1. Women aged =18 years (or emancipated minors) 2. Intrauterine pregnancy confirmed by ultrasound 3. Gestational age =63 days by ultrasound 4. Eligible for medication abortion under standard clinical criteria 5. Resident in Mexico City 6. Access to a telephone for follow-up 7. Able and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Liver or renal disease 2. Confirmed or suspected ectopic pregnancy, gestational trophoblastic disease, or undiagnosed adnexal mass 3. Intrauterine device (IUD) in situ 4. Known allergy to ulipristal acetate, misoprostol, or other prostaglandins 5. Unwilling or unable to attend follow-up visit 6. Unable to provide informed consent

Design outcomes

Primary

Measure	Time frame
1. Efficacy — Complete abortion without need for surgical intervention or additional misoprostol measured by proportion of participants with successful medication abortion at follow-up visit (7–10 days after ulipristal administration) 2. Safety — Occurrence of serious adverse events attributable to the study drugs measured by number and proportion of participants with serious adverse events from ulipristal administration until end of follow-up (7–10 days or extended if needed)	—

Measure

Time frame

1. Efficacy — Complete abortion without need for surgical intervention or additional misoprostol measured by proportion of participants with successful medication abortion at follow-up visit (7–10 days after ulipristal administration) 2. Safety — Occurrence of serious adverse events attributable to the study drugs measured by number and proportion of participants with serious adverse events from ulipristal administration until end of follow-up (7–10 days or extended if needed)

—

Secondary

Measure	Time frame
Acceptability — Participant-reported satisfaction with the regimen (and willingness to recommend) measured by proportion rating experience as “satisfied/very satisfied” on structured exit interview (Form 3) at follow-up visit 7–10 days after ulipristal (or at extended follow-up, if applicable)	—

Countries

Mexico

Contacts

Public ContactManuel Bousiéguez

mbousieguez@gynuity.org+52 55 5418-6607

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026