Actively Recruiting

Phase 3
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT06727734

Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

Led by The University of Hong Kong · Updated on 2026-05-14

980

Participants Needed

1

Research Sites

140 weeks

Total Duration

On this page

Sponsors

T

The University of Hong Kong

Lead Sponsor

T

The Family Planning Association of Hong Kong

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 45 years
  • Requesting oral emergency contraception within 120 hours of a single or first unprotected intercourse in the current menstrual cycle
  • Available for follow-up over the next 6 weeks
Not Eligible

You will not qualify if you...

  • Post-abortion or postpartum with menstruation not yet returned
  • Currently taking anticoagulants, cyclosporine, tacrolimus, corticosteroids, lithium, SSRIs, or quinolones
  • More than 120 hours since unprotected intercourse in this cycle
  • Pregnant at time of presentation
  • Breastfeeding
  • Sterilized or partner sterilized, or having an intrauterine contraceptive device
  • Uncertain about date of last menstrual period
  • Used hormonal contraceptive, progestogen medication, or NSAID in the past week
  • History of asthma, urticaria, or allergic reactions to piroxicam, aspirin, or other NSAIDs
  • History of ischemic heart disease, heart failure, hypertension, cerebrovascular disease, or kidney failure requiring dialysis
  • History of peptic ulcer disease or gastrointestinal bleeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Family Planning Association of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

R

Raymond Hang Wun Li, MD, FRCOG

CONTACT

S

Sue Seen Tsing Lo, MD, FRCOG

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception | DecenTrialz