Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Contraception

In brief

The goal of this clinical trial is to compare the failure rate of the levonorgestrel (LNG)-piroxicam combination regimen versus ulipristal acetate (UPA) as emergency contraception (EC). The main questions it aims to answer are: 1. whether the LNG-piroxicam combination regimen has a lower failure rate than UPA for EC; 2. whether the LNG-piroxicam combination regimen has a higher percentage of pregnancies prevented than UPA for EC 3. whether there is any difference in the change in the subsequent menstrual cycle and adverse effect profile between the two regimens Participants will: 1. Take a single dose of either (i) LNG 1.5 mg plus piroxicam 40 mg and a placebo tablet resembling UPA, or (ii) UPA 30 mg plus placebo tablets resembling LNG and piroxicam. 2. Have a blood test for serum LH, oestradiol an progesterone. 3. Keep a diary of their vaginal bleeding episodes, adverse effects symptoms, any further acts of intercourse and the type of contraception used. 4. Have a follow-up either in person by phone about 1-2 weeks after the next expected menstruation. 5. If normal menstrual bleeding has not occurred by that time, a pregnancy test will be carried out.

Key facts

Study ID: NCT06727734
Run by: The University of Hong Kong
People needed: 980
Starts: 2025-01-18
Expected to finish: 2027-10-01
Last updated by the study team: 2026-05-14

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

women aged 18-45 years;
requesting an oral EC within 120 hours of a single or the first act of unprotected intercourse in the current menstrual cycle;
available for follow-up over the next 6 weeks.

You may not qualify if…

post-abortion or postpartum and period have not yet returned,
being on the following drugs currently: anticoagulants, cyclosporine, tacrolimus, corticosteroids, lithium, serotonin reuptake inhibitors (SSRIs), quinolones
having unprotected intercourse in this cycle more than 120 hours before attending the clinic,
being found pregnant at the time of presentation,
breastfeeding,
having been sterilized (or partner having been sterilized) or having intrauterine contraceptive device in-situ,
uncertain about the date of the last menstrual period,
having used a hormonal contraceptive (including EC), progestogen-containing medication or NSAID in the recent one week,
having history of asthma, urticaria or other allergic reactions to piroxicam, aspirin or other NSAIDs,
having history of ischaemic heart disease, heart failure, hypertension, cerebrovascular disease or kidney failure requiring dialysis
having history of peptic ulcer disease and/or gastrointestinal bleeding.

Where it is running

The Family Planning Association of Hong Kong — Hong Kong, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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