ContraceptionPhase 3NCT06727734
Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception
A Phase 3 study testing Levonorgestrel, Piroxicam and Ulipristal Acetate in people with Contraception, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel, Piroxicam and Ulipristal Acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 980 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Jan 2025to Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Family Planning Association of Hong Kong
Hong Kong
Sue Seen Tsing Lo, MD, FRCOG, +852 29197726, stlo@famplan.org.hk
Raymond Hang Wun Li, MD, FRCOG
About this study
Official title: Levonorgestrel-piroxicam Combination Versus Ulipristal Acetate for Emergency Contraception: a Randomised Double-blind Controlled 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:
- whether the LNG-piroxicam combination regimen has a lower failure rate than UPA for EC;
- whether the LNG-piroxicam combination regimen has a higher percentage of pregnancies prevented than UPA for EC
- whether there is any difference in the change in the subsequent menstrual cycle and adverse effect profile between the two regimens
Read more
Participants will:
- 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.
- Have a blood test for serum LH, oestradiol an progesterone.
- Keep a diary of their vaginal bleeding episodes, adverse effects symptoms, any further acts of intercourse and the type of contraception used.
- Have a follow-up either in person by phone about 1-2 weeks after the next expected menstruation.
- If normal menstrual bleeding has not occurred by that time, a pregnancy test will be carried out.
Read the detailed description
Participating women will be randomised to either the LNG-piroxicam group or UPA group in 1:1 ratio according to a computer-generated randomisation list in varying blocks. Serially numbered vouchers bearing the drug code in sealed envelopes will be prepared, according to which the study medication will be prepacked by another research nurse not directly involved in patient contact in this study. The subjects, clinicians and research staff with patient contact will be blinded to the group assignment. The codes for the treatment groups will only be revealed to the investigators after completion of the whole study and statistical analyses.
Baseline assessment of subjects:
- Medical and menstrual history will be taken.
- Measurement of body height, weight and blood pressure.
- Pregnancy test
- Measurement of serum LH, oestradiol and progesterone to classify the subject as pre-ovulatory versus post-ovulatory. The serum hormonal levels will be used to estimate the phase of the menstrual cycle at the time of presentation in relation to the day of ovulation.
Treatment:
The recruited subjects will receive the assigned study medications under direct supervision. Those in the LNG-piroxicam group will receive piroxicam 40 mg, LNG 1.5 mg and a placebo pill resembling UPA. Those in the UPA group will receive UPA 30 mg and placebo pills resembling LNG and piroxicam respectively. They will be given a diary chart to record vaginal spotting and bleeding, possible side effects and further acts of intercourse, if any, and the contraceptive method used.
Follow-up:
A follow-up (either in person or by phone as pre-agreed at recruitment) will be arranged by the research nurse about 1-2 weeks after the next expected menstruation (this is incorporated into her routine clinic follow-up). Information collected at the follow-up visit will include side effects and vaginal bleeding/spotting marked by the subject on her diary card, time of onset, duration and amount of menstrual bleeding, any further acts of intercourse and the type of contraception used. If normal menstrual bleeding has not occurred by that time, a pregnancy test will be carried out, and a positive result denotes treatment failure and the woman will be counselled accordingly. Those deciding to continue with pregnancy will be referred for antenatal care. An additional research follow-up will be arranged post-delivery to record any antenatal, postnatal and neonatal complications. If the woman opts for terminating the pregnancy, she will be referred to the appropriate services. If the woman misses the appointment and does not contact the clinic, the researchers will reach her by phone (either voice call or text messaging) as soon as possible after the missed visit.
- Conditions
- Contraception
- Being tested
- Levonorgestrel, Piroxicam, Ulipristal Acetate, Placebo - LNG, Placebo - Piroxicam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevonorgestrelDrug
Also called Anlitin
Levonorgestrel 1.5 mg
PiroxicamDrug
Also called CP-Pirox
Piroxicam 40 mg
Ulipristal AcetateDrug
Also called Ella
Ulipristal 30 mg
Placebo - LNGDrug
Placebo of levonorgestrel
Placebo - PiroxicamDrug
Placebo of piroxicam
Placebo - UPADrug
Placebo of ulipristal acetate
| Study group | Role | What they receive |
|---|---|---|
| LNG-piroxicam | Experimental | Levonorgestrel-piroxicam combination Receives: Drug: Levonorgestrel; Drug: Piroxicam; Drug: Placebo - UPA |
| UPA | Active comparator | Ulipristal only Receives: Drug: Ulipristal Acetate; Drug: Placebo - LNG; Drug: Placebo - Piroxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Percentage of women having positive hCG test within one month
Measured: 1 month
Secondary outcomes (3)
Percentage of pregnancies prevented
Percentage of pregnancies (based on published theoretical model) that are prevented in the treatment group
Measured: 1 month
Percentage of participants with advancement or delay of next menses
Percentage of women experiencing advancement or delay of next menstruation within one month
Measured: 1 month
Adverse effects
Percentage of women experiencing other adverse effects within one month
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start18 Jan 2025
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Family Planning Association of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Raymond Hang Wun Li, MD, FRCOG, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727734
- Sponsor's protocol ID
- UW 24-054
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levonorgestrel-piroxicam Combination Versus Ulipristal Acetate for Emergency Contraception: a Randomised Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT06727734
- Acronym / sponsor ID
- UW 24-054
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 980 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Family Planning Association of Hong Kong
- Study start
- 18 Jan 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- whether the LNG-piroxicam combination regimen has a lower failure rate than UPA for EC;
- whether the LNG-piroxicam combination regimen has a higher percentage of pregnancies prevented than UPA for EC
- whether there is any difference in the change in the subsequent menstrual cycle and adverse effect profile between the two regimens
Participants will:
- 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.
- Have a blood test for serum LH, oestradiol an progesterone.
- Keep a diary of their vaginal bleeding episodes, adverse effects symptoms, any further acts of intercourse and the type of contraception used.
- Have a follow-up either in person by phone about 1-2 weeks after the next expected menstruation.
- If normal menstrual bleeding has not occurred by that time, a pregnancy test will be carried out.
Detailed description
Participating women will be randomised to either the LNG-piroxicam group or UPA group in 1:1 ratio according to a computer-generated randomisation list in varying blocks. Serially numbered vouchers bearing the drug code in sealed envelopes will be prepared, according to which the study medication will be prepacked by another research nurse not directly involved in patient contact in this study. The subjects, clinicians and research staff with patient contact will be blinded to the group assignment. The codes for the treatment groups will only be revealed to the investigators after completion of the whole study and statistical analyses.
Baseline assessment of subjects:
- Medical and menstrual history will be taken.
- Measurement of body height, weight and blood pressure.
- Pregnancy test
- Measurement of serum LH, oestradiol and progesterone to classify the subject as pre-ovulatory versus post-ovulatory. The serum hormonal levels will be used to estimate the phase of the menstrual cycle at the time of presentation in relation to the day of ovulation.
Treatment:
The recruited subjects will receive the assigned study medications under direct supervision. Those in the LNG-piroxicam group will receive piroxicam 40 mg, LNG 1.5 mg and a placebo pill resembling UPA. Those in the UPA group will receive UPA 30 mg and placebo pills resembling LNG and piroxicam respectively. They will be given a diary chart to record vaginal spotting and bleeding, possible side effects and further acts of intercourse, if any, and the contraceptive method used.
Follow-up:
A follow-up (either in person or by phone as pre-agreed at recruitment) will be arranged by the research nurse about 1-2 weeks after the next expected menstruation (this is incorporated into her routine clinic follow-up). Information collected at the follow-up visit will include side effects and vaginal bleeding/spotting marked by the subject on her diary card, time of onset, duration and amount of menstrual bleeding, any further acts of intercourse and the type of contraception used. If normal menstrual bleeding has not occurred by that time, a pregnancy test will be carried out, and a positive result denotes treatment failure and the woman will be counselled accordingly. Those deciding to continue with pregnancy will be referred for antenatal care. An additional research follow-up will be arranged post-delivery to record any antenatal, postnatal and neonatal complications. If the woman opts for terminating the pregnancy, she will be referred to the appropriate services. If the woman misses the appointment and does not contact the clinic, the researchers will reach her by phone (either voice call or text messaging) as soon as possible after the missed visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNG-piroxicam | Experimental | Drug: Levonorgestrel, Drug: Piroxicam, Drug: Placebo - UPALevonorgestrel-piroxicam combination |
| UPA | Active comparator | Drug: Ulipristal Acetate, Drug: Placebo - LNG, Drug: Placebo - PiroxicamUlipristal only |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevonorgestrelAlso: AnlitinLevonorgestrel 1.5 mg | Drug | LNG-piroxicam |
| PiroxicamAlso: CP-PiroxPiroxicam 40 mg | Drug | LNG-piroxicam |
| Ulipristal AcetateAlso: EllaUlipristal 30 mg | Drug | UPA |
| Placebo - LNGPlacebo of levonorgestrel | Drug | UPA |
| Placebo - PiroxicamPlacebo of piroxicam | Drug | UPA |
| Placebo - UPAPlacebo of ulipristal acetate | Drug | LNG-piroxicam |
Primary outcome
Pregnancy rate
Time frame: 1 month
Percentage of women having positive hCG test within one month
3 secondary outcomes
Percentage of pregnancies prevented
Time frame: 1 month
Percentage of participants with advancement or delay of next menses
Time frame: 1 month
Adverse effects
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raymond Hang Wun Li, MD, FRCOG principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levonorgestrel, Piroxicam and Ulipristal Acetate in people with Contraception, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raymond Hang Wun Li, MD, FRCOG (+852 22554517, raymondli@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.