Health TrialsbyHealthPanel

Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

ConditionContraception
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

women aged 18-45 years;

requesting an oral EC within 120 hours of a single or the first act of unprotected intercourse in the current menstrual cycle;

available for follow-up over the next 6 weeks.

Disqualifiers

post-abortion or postpartum and period have not yet returned,

being on the following drugs currently: anticoagulants, cyclosporine, tacrolimus, corticosteroids, lithium, serotonin reuptake inhibitors (SSRIs), quinolones

having unprotected intercourse in this cycle more than 120 hours before attending the clinic,

being found pregnant at the time of presentation,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

980 Participants
are divided into 2 treatment groups
Group A: LNG-piroxicamExperimental treatment 3 interventions
Group B: UPAActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Pregnancy rate

Percentage of women having positive hCG test within one month

Time frame
1 month

Secondary outcomes

1

Percentage of pregnancies prevented

Percentage of pregnancies (based on published theoretical model) that are prevented in the treatment group

Time frame
1 month
2

Percentage of participants with advancement or delay of next menses

Percentage of women experiencing advancement or delay of next menstruation within one month

Time frame
1 month
3

Adverse effects

Percentage of women experiencing other adverse effects within one month

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

The Family Planning Association of Hong Kong

Collaborator

Source ClinicalTrials.gov
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