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Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

RecruitingPhase 3Ages 18 Years - 45 YearsFemaleThe University of Hong Kong
NCT06727734 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 sympt

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📋 Eligibility rules (as published)
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.
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What it tests

  • Levonorgestrel
  • Piroxicam
  • Ulipristal Acetate
  • Placebo - LNG
  • Placebo - Piroxicam
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Where

1 site
The Family Planning Association of Hong Kong
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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