Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

NCT06727734 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: UW 24-054
• Study Type: interventional
• Target: 980
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.whether the LNG-piroxicam combination regimen has a lower failure rate than UPA for EC;
2. 2.whether the LNG-piroxicam combination regimen has a higher percentage of pregnancies prevented than UPA for EC
3. 3.whether there is any difference in the change in the subsequent menstrual cycle and adverse effect profile between the two regimens
4. 4.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.
5. 5.Have a blood test for serum LH, oestradiol an progesterone.
6. 6.Keep a diary of their vaginal bleeding episodes, adverse effects symptoms, any further acts of intercourse and the type of contraception used.
7. 7.Have a follow-up either in person by phone about 1-2 weeks after the next expected menstruation.
8. 8.If normal menstrual bleeding has not occurred by that time, a pregnancy test will be carried out.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  Percentage of women having positive hCG test within one month

  1 month

Secondary Outcomes (3)

• Percentage of pregnancies prevented

  1 month

• Change in bleeding pattern

  1 month

• Adverse effects

  1 month

Study Arms (2)

LNG-piroxicam

EXPERIMENTAL

Levonorgestrel-piroxicam combination

Drug: Levonorgestrel; Drug: Piroxicam; Drug: Placebo - UPA

UPA

ACTIVE COMPARATOR

Ulipristal only

Drug: Ulipristal Acetate; Drug: Placebo - LNG; Drug: Placebo - Piroxicam

Interventions

Levonorgestrel DRUG

Levonorgestrel 1.5 mg

Also known as: Anlitin

LNG-piroxicam

Piroxicam DRUG

Piroxicam 40 mg

Also known as: CP-Pirox

LNG-piroxicam

Ulipristal Acetate DRUG

Ulipristal 30 mg

Also known as: Ella

UPA

Placebo - LNG DRUG

Placebo of levonorgestrel

UPA

Placebo - Piroxicam DRUG

Placebo of piroxicam

UPA

Placebo - UPA DRUG

Placebo of ulipristal acetate

LNG-piroxicam

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Biological gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• breastfeeding,
• having been sterilized (or partner having been sterilized) or having intrauterine contraceptive device in-situ,
• uncertain about the date of the last menstrual period,
• having used a hormonal contraceptive (including EC), progestogen-containing medication or NSAID in the recent one week,
• having history of asthma, urticaria or other allergic reactions to piroxicam, aspirin or other NSAIDs,
• having history of ischaemic heart disease, heart failure, hypertension, cerebrovascular disease or kidney failure requiring dialysis
• having history of peptic ulcer disease and/or gastrointestinal bleeding.

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Family Planning Association of Hong Kong: collaborator

MeSH Terms

Interventions

Levonorgestrel; Piroxicam; ulipristal acetate

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Raymond Hang Wun Li, MD, FRCOG

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Hang Wun Li, MD, FRCOG

CONTACT

+852 22554517; raymondli@hku.hk

Sue Seen Tsing Lo, MD, FRCOG

CONTACT

+852 29197726; stlo@famplan.org.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: From commencement of the study till 3 years after study completion
• Access Criteria: Upon reasonably request made to the principal investigator