Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception (NCT06727734) | Clinical Trial Compass
RecruitingPhase 3
Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception
Hong Kong980 participantsStarted 2025-01-18
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 range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.