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Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception
Sponsor: The University of Hong Kong
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.
Official title: Levonorgestrel-piroxicam Combination Versus Ulipristal Acetate for Emergency Contraception: a Randomised Double-blind Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
980
Start Date
2024-12
Completion Date
2027-10
Last Updated
2024-12-27
Healthy Volunteers
Yes
Conditions
Interventions
Levonorgestrel
Levonorgestrel 1.5 mg
Piroxicam
Piroxicam 40 mg
Ulipristal Acetate
Ulipristal 30 mg
Placebo - LNG
Placebo of levonorgestrel
Placebo - Piroxicam
Placebo of piroxicam
Placebo - UPA
Placebo of ulipristal acetate