Levonorgestrel–piroxicam plus placebo vs ulipristal acetate plus placebo for emergency contraception

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial compares two emergency contraception regimens in women who need EC after unprotected intercourse. Participants are randomized to receive either LNG 1.5 mg with piroxicam 40 mg and a placebo matching ulipristal, or UPA 30 mg with placebos matching LNG and piroxicam, with blinding of participants and staff. The study collects hormonal data, diaries on bleeding and adverse effects, and follow-up over about six weeks to evaluate pregnancy failure rates, proportion of pregnancies prevented, menstrual cycle changes, and safety. Baseline assessments include medical history, vital signs, pregnancy testing, and serum hormone levels to estimate ovulatory status. Treatment is administered under supervision at sites affiliated with The University of Hong Kong and The Family Planning Association of Hong Kong.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Family Planning Association of Hong Kong
  Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Raymond Hang Wun Li, MD, FRCOG — The University of Hong Kong
• Study coordinator: Raymond Hang Wun Li, MD, FRCOG
• Email: raymondli@hku.hk
• Phone: +852 22554517

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.