About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Levonorgestrel
- Piroxicam
- Ulipristal Acetate
- Placebo - LNG
- Placebo - Piroxicam
- Placebo - UPA
Treatment groups
Sponsors and collaborators
The University of Hong Kong
Lead sponsor
The Family Planning Association of Hong Kong
Collaborator