NCT06727734 Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception
| NCT ID | NCT06727734 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The University of Hong Kong |
| Condition | Contraception |
| Study Type | INTERVENTIONAL |
| Enrollment | 980 participants |
| Start Date | 2025-01-18 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 980 participants in total. It began in 2025-01-18 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. women aged 18-45 years; 2. requesting an oral EC within 120 hours of a single or the first act of unprotected intercourse in the current menstrual cycle; 3. available for follow-up over the next 6 weeks. Exclusion Criteria: 1. post-abortion or postpartum and period have not yet returned, 2. being on the following drugs currently: anticoagulants, cyclosporine, tacrolimus, corticosteroids, lithium, serotonin reuptake inhibitors (SSRIs), quinolones 3. having unprotected intercourse in this cycle more than 120 hours before attending the clinic, 4. being found pregnant at the time of presentation, 5. breastfeeding, 6. having been sterilized (or partner having been sterilized) or having intrauterine contraceptive device in-situ, 7. uncertain about the date of the last menstrual period, 8. having used a hormonal contraceptive (including EC), progestogen-containing medication or NSAID in the recent one week, 9. having history of asthma, urticaria or other allergic reactions to piroxicam, aspirin or other NSAIDs, 10. having history of ischaemic heart disease, heart failure, hypertension, cerebrovascular disease or kidney failure requiring dialysis 11. having history of peptic ulcer disease and/or gastrointestinal bleeding.
Contact & Investigator
Raymond Hang Wun Li, MD, FRCOG
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT06727734 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Contraception. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06727734 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 980 participants.
Is NCT06727734 currently recruiting?
Yes, NCT06727734 is actively recruiting participants. Contact the research team at raymondli@hku.hk for enrollment information.
Where is the NCT06727734 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06727734 clinical trial?
NCT06727734 is sponsored by The University of Hong Kong. The principal investigator is Raymond Hang Wun Li, MD, FRCOG at The University of Hong Kong. The trial plans to enroll 980 participants.