Evaluating the use of ulipristal acetate with and without misoprostol for contragestion

Safety, efficacy and acceptability of ulipristal acetate with and without misoprostol for contragestion through 35 days LMP

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78613350

Enrollment

500

Registered

2025-10-15

Start date

2026-05-04

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Prevention or disruption of unwanted pregnancy in women up to 35 days LMP Pregnancy and Childbirth

Interventions

Arm 1: 60 mg (two 30 mg tablets) ulipristal acetate orally, followed 24 hours later by 800 mcg (four 200 mcg tablets) of misoprostol buccally. Arm 2: 60 mg (two 30 mg tablets) ulipristal acetate ora

Eligibility

Sex/Gender

Female

Age

18 Years to 39 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-39 years 2. LMP =35 days, as verified by report of last menstrual period 3. Missed the EC window (had unprotected sex >5 days ago) 4. General good health 5. Does not want to be pregnant 6. History of regular monthly menstrual cycles (±3 days) 7. Willing and able to understand and sign consent forms 8. Willing to return for a follow-up visit 9. Willing to provide a blood draw at enrollment and urine sample at follow-up

Exclusion criteria

Exclusion criteria: 1. Known allergies or contraindications to either of the study drugs 2. Symptoms of or risk factors for ectopic pregnancy, including: 2.1. Unilateral pelvic pain or significant bilateral pelvic pain within the past week 2.2. Prior ectopic pregnancy 2.3. Prior permanent contraception or other tubal surgery 3. Current use of an IUD, contraceptive implant or injectable 4. History of renal or liver disease

Design outcomes

Primary

Measure	Time frame
Proportion of study participants not pregnant at follow-up, as determined by urine pregnancy test and, for those with a positive urine test, ultrasound	—

Secondary

Measure	Time frame
1. Self-reported incidence of side effects (diarrhea, nausea/vomiting, cramps, fever, chills or other) after taking the study medications, as measured by an exit interview at follow-up. 2. Acceptability of the contragestive medications to participants, defined as the proportion of participants who report at follow-up that the medications were acceptable or highly acceptable. 3. Incidence of bleeding within five days after administering the study medications, defined as the proportion of participants who report at follow-up that they experienced any bleeding in the first 5 days after taking the study medications. 4. Duration of bleeding in days following administration of the study medications, defined as the number of days that participants report experiencing bleeding after taking the study medications, as measured by an exit interview at follow-up. 5. Severity of bleeding following administration of study medications, defined as the proportion of participants who report that the bleeding they experienced was very severe, somewhat severe, or not severe at all, as measured by an exit interview at follow-up.	—

Measure

Time frame

1. Self-reported incidence of side effects (diarrhea, nausea/vomiting, cramps, fever, chills or other) after taking the study medications, as measured by an exit interview at follow-up. 2. Acceptability of the contragestive medications to participants, defined as the proportion of participants who report at follow-up that the medications were acceptable or highly acceptable. 3. Incidence of bleeding within five days after administering the study medications, defined as the proportion of participants who report at follow-up that they experienced any bleeding in the first 5 days after taking the study medications. 4. Duration of bleeding in days following administration of the study medications, defined as the number of days that participants report experiencing bleeding after taking the study medications, as measured by an exit interview at follow-up. 5. Severity of bleeding following administration of study medications, defined as the proportion of participants who report that the bleeding they experienced was very severe, somewhat severe, or not severe at all, as measured by an exit interview at follow-up.

—

Countries

Mexico

Contacts

Public ContactWendy Sheldon

wsheldon@vergeresearch.org+1 (0)9172879052

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026