Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

Sponsor
The University of Hong Kong
Study ID
NCT06727734
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Contraception

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Levonorgestrel — DRUG
    Levonorgestrel 1.5 mg
  • Piroxicam — DRUG
    Piroxicam 40 mg
  • Ulipristal Acetate — DRUG
    Ulipristal 30 mg
  • Placebo - LNG — DRUG
    Placebo of levonorgestrel
  • Placebo - Piroxicam — DRUG
    Placebo of piroxicam
  • Placebo - UPA — DRUG
    Placebo of ulipristal acetate

Study Details

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.

Key Dates

First listed
Dec 11, 2024
Start date
Jan 18, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
980 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LNG-piroxicam
    Levonorgestrel-piroxicam combination
  • Active Comparator: UPA
    Ulipristal only

Primary Outcome Measure

Pregnancy rate [ Time Frame: 1 month ]

Central Contacts

Related Studies