Emergency ContraceptionPhase 2/3NCT03614494
Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception
A Phase 2/3 study testing Piroxicam 40 mg and Levonorgestrel 1.5mg in people with Emergency Contraception, run by Dr. Hang Wun Raymond Li at 2 sites in Hong Kong.
Trial summary
This is a randomised controlled trial aimed at comparing the efficacy of levonorgestrel (LNG) co-administered with piroxicam or placebo for oral emergency contraception (EC). Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) commonly used as a pain-killer in inflammatory conditions. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emergency Contraception
- What is being tested?
- Piroxicam 40 mg and Levonorgestrel 1.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 860 participants
- Where
- 2 sitesHong Kong
- Study dates
- 20 Aug 2018to 5 Oct 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy women aged 18 years or above;
- requesting emergency contraception within 72 h of a single act of unprotected intercourse in the current menstrual cycle;
- having menstrual cycles between 24 and 42 days
- willing to abstain from further acts of unprotected intercourse and;
- available for follow-up over the next 6 weeks.
Who cannot join
- post-abortion or postpartum and period have not yet returned,
- being on prescription drugs currently
- having unprotected intercourse in this cycle more than 72 hours or more than once 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,
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- uncertain about the date of the last menstrual period,
- having used hormonal contraceptive (including EC pill) or NSAID in the current or past one cycle,
- having history of asthma, urticarial or other allergic reactions to piroxicam, aspirin or other NSAIDs,
- having history of ischaemic heart disease in the past one year
- having history of pelvic ulcer disease and/or gastrointestinal bleeding
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
The Family Planning Association of Hong Kong
Hong Kong
About this study
Official title: Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception: Randomised Controlled Trial
This is a randomised controlled trial aimed at comparing the efficacy of levonorgestrel (LNG) co-administered with piroxicam or placebo for oral emergency contraception (EC). Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) commonly used as a pain-killer in inflammatory conditions. Efficacy will be measured as the percentage of pregnancies prevented.
Read the detailed description
Objective: To compare the percentage of pregnancies prevented by LNG co-administered with piroxicam or placebo for oral emergency contraception (EC) by a randomised controlled trial.
Hypothesis to be tested: LNG plus piroxicam has higher percentage of pregnancies prevented compared with LNG plus placebo for oral emergency contraception.
Design and subjects: This will be a prospective, randomised placebo-controlled clinical trial. Women attending the Family Planning Association of Hong Kong for oral EC within 72 hours of unprotected sexual intercourse will be recruited.
Study instruments: Prospective follow-up of subjects in the clinic for the primary and secondary outcomes.
Interventions: Eligible subjects will be randomised to receive one of the two treatment regimens, i.e. Group A: a single dose of LNG 1.5 mg and piroxicam 40 mg, or Group B: a single dose of LNG 1.5mg and placebo under direct supervision.
Main outcome measures: Percentage of pregnancies prevented (PPP) is the primary outcome measure. Secondary outcome measures include failure rate, rate of occurrence of side effects and pattern of the menstruation following EC.
Data analysis:The percentage of pregnancies prevented, failure rate and rate of occurrence of side effects will be compared between groups using Fisher-Exact test. Continuous variables regarding menstrual pattern between the two groups will be compared by Mann-Whitney U test.
Expected results: LNG plus piroxicam has a higher PPP compared to LNG plus placebo.
- Conditions
- Emergency Contraception
- Being tested
- Piroxicam 40 mg, Levonorgestrel 1.5mg
- Keywords
- Piroxicam, Levonorgestrel, Placebo, Randomised controlled control, Emergency contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piroxicam 40 mgDrug
Additional co-treatment
Levonorgestrel 1.5mgDrug
Standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Piroxicam | Active comparator | Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose Receives: Drug: Piroxicam 40 mg; Drug: Levonorgestrel 1.5mg |
| Placebo | Placebo comparator | Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose Receives: Drug: Levonorgestrel 1.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Pregnancies Prevented
(number of expected pregnancies - number of observed pregnancies) / number of expected pregnancies. The number of expected pregnancies is calculated based on the cycle day on which unprotected sexual intercourse occurred in each woman according to the model published by Trussel et al (Trussell J et al, Contraception 2003; 67:259-265).
Measured: 1 month
Secondary outcomes (1)
Pregnancy Rate
number of participants who were pregnant / number of efficacy-evaluable participants
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 posted3 Aug 2018
- Study start20 Aug 2018
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency ContraceptionStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 860 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Hang Wun Raymond Li
- Sponsor type
- University, hospital or other
- Collaborators
- The Family Planning Association of Hong Kong
- Responsible party
- Sponsor-investigator, Dr. Hang Wun Raymond Li, The University of Hong Kong
- Investigators
- Hang Wun Raymond Li, MD, FRCOG, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614494
- Sponsor's protocol ID
- UW18-003
- Status last verified
- Nov 2023
- First submitted
- 29 Jul 2018
- Last updated
- 6 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be assessed and endorsed by the investigation team based on the exact study protocol suggested by the other researchers.
Publications
Li RHW, Lo SST, Gemzell-Danielsson K, Fong CHY, Ho PC, Ng EHY. Oral emergency contraception with levonorgestrel plus piroxicam: a randomised double-blind placebo-controlled trial. Lancet. 2023 Sep 9;402(10405):851-858. doi: 10.1016/S0140-6736(23)01240-0. Epub 2023 Aug 16.
PubMed 37597523
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03614494
- Acronym / sponsor ID
- UW18-003
- Conditions
- Emergency Contraception
- Keywords
- Piroxicam, Levonorgestrel, Placebo, Randomised controlled control, Emergency contraception
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- Dr. Hang Wun Raymond LiUniversity, hospital or other
- Collaborators
- The Family Planning Association of Hong Kong
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 6 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised controlled trial aimed at comparing the efficacy of levonorgestrel (LNG) co-administered with piroxicam or placebo for oral emergency contraception (EC). Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) commonly used as a pain-killer in inflammatory conditions. Efficacy will be measured as the percentage of pregnancies prevented.
Detailed description
Objective: To compare the percentage of pregnancies prevented by LNG co-administered with piroxicam or placebo for oral emergency contraception (EC) by a randomised controlled trial.
Hypothesis to be tested: LNG plus piroxicam has higher percentage of pregnancies prevented compared with LNG plus placebo for oral emergency contraception.
Design and subjects: This will be a prospective, randomised placebo-controlled clinical trial. Women attending the Family Planning Association of Hong Kong for oral EC within 72 hours of unprotected sexual intercourse will be recruited.
Study instruments: Prospective follow-up of subjects in the clinic for the primary and secondary outcomes.
Interventions: Eligible subjects will be randomised to receive one of the two treatment regimens, i.e. Group A: a single dose of LNG 1.5 mg and piroxicam 40 mg, or Group B: a single dose of LNG 1.5mg and placebo under direct supervision.
Main outcome measures: Percentage of pregnancies prevented (PPP) is the primary outcome measure. Secondary outcome measures include failure rate, rate of occurrence of side effects and pattern of the menstruation following EC.
Data analysis:The percentage of pregnancies prevented, failure rate and rate of occurrence of side effects will be compared between groups using Fisher-Exact test. Continuous variables regarding menstrual pattern between the two groups will be compared by Mann-Whitney U test.
Expected results: LNG plus piroxicam has a higher PPP compared to LNG plus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piroxicam | Active comparator | Drug: Piroxicam 40 mg, Drug: Levonorgestrel 1.5mgPiroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose |
| Placebo | Placebo comparator | Drug: Levonorgestrel 1.5mgPlacebo (2 tablets) + levonorgestrel 1.5 mg single oral dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- healthy women aged 18 years or above;
- requesting emergency contraception within 72 h of a single act of unprotected intercourse in the current menstrual cycle;
- having menstrual cycles between 24 and 42 days
- willing to abstain from further acts of unprotected intercourse and;
- 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 prescription drugs currently
- having unprotected intercourse in this cycle more than 72 hours or more than once 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 |
|---|---|---|
| Piroxicam 40 mgAdditional co-treatment | Drug | Piroxicam |
| Levonorgestrel 1.5mgStandard treatment | Drug | Piroxicam, Placebo |
Primary outcome
Percentage of Pregnancies Prevented
Time frame: 1 month
(number of expected pregnancies - number of observed pregnancies) / number of expected pregnancies. The number of expected pregnancies is calculated based on the cycle day on which unprotected sexual intercourse occurred in each woman according to the model published by Trussel et al (Trussell J et al, Contraception 2003; 67:259-265).
1 secondary outcome
Pregnancy Rate
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37597523Li RHW, Lo SST, Gemzell-Danielsson K, Fong CHY, Ho PC, Ng EHY. Oral emergency contraception with levonorgestrel plus piroxicam: a randomised double-blind placebo-controlled trial. Lancet. 2023 Sep 9;402(10405):851-858. doi: 10.1016/S0140-6736(23)01240-0. Epub 2023 Aug 16.
- Individual participant dataSharing planned: Yes. To be assessed and endorsed by the investigation team based on the exact study protocol suggested by the other researchers.
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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. This study is not recruiting at the moment.
Hang Wun Raymond Li, MD, FRCOG principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Piroxicam 40 mg and Levonorgestrel 1.5mg in people with Emergency Contraception, run by Dr. Hang Wun Raymond Li at 2 sites 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 5 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: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 6 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Pregnancies Prevented (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03614494, which also lists 1 linked publication.
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 6 May 2024.