Safety, efficacy and acceptability of ulipristal acetate with and without misoprostol for contragestion through 35 days LMP
Prevention or disruption of unwanted pregnancy in women up to 35 days LMP
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 orally, followed 24 hours later by four placebo tablets buccally. Randomization is 1:1 and carried out in blocks of 8 for each study site using a computer program.
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
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