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NOT YET RECRUITING
NCT06727734
PHASE3

Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

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

DRUG

Levonorgestrel

Levonorgestrel 1.5 mg

DRUG

Piroxicam

Piroxicam 40 mg

DRUG

Ulipristal Acetate

Ulipristal 30 mg

DRUG

Placebo - LNG

Placebo of levonorgestrel

DRUG

Placebo - Piroxicam

Placebo of piroxicam

DRUG

Placebo - UPA

Placebo of ulipristal acetate