Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception (NCT06727734) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception
980 participantsStarted 2024-12
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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,