Emergency ContraceptionPhase 3RAPPELNCT07449299
Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel
A Phase 3 study testing Levonorgestrel 1.5 mg and Piroxicam 40 mg in people with Emergency Contraception and Contraception, run by University of Utah.
Trial summary
This randomized controlled trial will test oral levonorgestrel + piroxicam vs. levonorgestrel + placebo for emergency contraception in a representative U.S. population that has higher pregnancy risk than in the prior study because of higher weights, different intercourse patterns, and different clinic accessibility. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women only
- Conditions the study is for
- Emergency Contraception, Contraception, COX-2 Inhibitor
- What is being tested?
- Levonorgestrel 1.5 mg and Piroxicam 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,458 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Nov 2031
- 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 16 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between 16-35 years old and desire LNG for EC
- Unprotected intercourse within 72 hours
- Biologically capable of pregnancy
- Regular menstrual cycle 21-35 days long with known LMP +/- 3 days
- Working cell phone number that receives text messages (for Aim 3 participants phone with capability to download and use the Oova application and submit data)
- Fluent in English and/or Spanish
- Willing to comply with the study requirements including 1-month urine pregnancy test
- No known contraindications to oral LNG or piroxicam - For secondary outcome assessing pregnancy risk for participants receiving study drug on day of ovulation or later - are currently using a menstrual cycle tracking application and can demonstrate according to the application that they are on the day of ovulation or post ovulation.
Who cannot join
- Current pregnancy (+urine pregnancy test in clinic)
- Breastfeeding, post abortion or postpartum without resuming menstruation
- Use of hormonal contraception (including oral EC) within seven days of enrollment
- Use of NSAIDs (ibuprofen, naproxen, celecoxib, diclofenac, aspirin) in the prior week
- Highly effective contraception including permanent contraception (including partner with vasectomy), IUD, or contraceptive implant
- Allergy to LNG or piroxicam
- Desires UPA for EC
- History of stroke, myocardia infarction, ischemic heart disease, uncontrolled hypertension, congestive heart failure, peptic ulcer disease, renal or hepatic failure. Currently taking anticoagulants, corticosteroids, cyclosporine, lithium, methotrexate, or tacrolimus.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This randomized controlled trial will test oral levonorgestrel + piroxicam vs. levonorgestrel + placebo for emergency contraception in a representative U.S. population that has higher pregnancy risk than in the prior study because of higher weights, different intercourse patterns, and different clinic accessibility. Data from this project will inform clinical practice in the U.S. and beyond for those desiring the most effective method of emergency contraception pills.
- Conditions
- Emergency Contraception, Contraception, COX-2 Inhibitor
- Being tested
- Levonorgestrel 1.5 mg and Piroxicam 40 mg, Oral LNG + Placebo
- Keywords
- Emergency Contraception, Piroxicam, Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel 1.5 mg and Piroxicam 40 mgDrug
The study intervention is a combination of Levonorgestrel 1.5 mg and Piroxicam 40 mg for emergency contraception. Participants will be randomized 3:1 to this vs. Levonorgestrel 1.5 mg and placebo.
Oral LNG + PlaceboDrug
The study intervention is a combination of Levonorgestrel 1.5 mg and placebo for emergency contraception. Participants will be randomized 3:1 to Levonorgestrel 1.5 mg and Piroxicam vs. this option.
| Study group | Role | What they receive |
|---|---|---|
| Oral LNG + Piroxicam | Experimental | Compare EC efficacy among 1,458 U.S. participants randomly assigned 3:1 to oral LNG + piroxicam vs. oral LNG + placebo. This ARM will provide participants Oral LNG plus Piroxicam. Receives: Drug: Levonorgestrel 1.5 mg and Piroxicam 40 mg |
| Oral LNG + Placebo | Placebo comparator | Compare EC efficacy among 1,458 U.S. participants randomly assigned 3:1 to oral LNG + piroxicam vs. oral LNG + placebo. This Arm will assign participants to oral lng plus a placebo. Receives: Drug: Oral LNG + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EC efficacy between the two study groups measured by pregnancy status four weeks after EC use.
The study's primary outcome is a confirmed pregnancy at four weeks (+/- 5 days) after EC study drug consumption as determined by a positive high sensitivity urine pregnancy test or clinical documentation of a pregnancy at any time that dates back to a fertilization date that is within 5 days of EC study drug consumption.
Measured: One month after consuming study drug
Secondary outcomes (2)
Pregnancy risk for participants weighing ≥75 kg compared between the two drug treatment groups.
The primary outcome for this aim will be the pregnancy risk for participants weighing ≥75 kg compared between the two drug treatment groups. We will compare the pregnancy risk among the subset of participants weighing ≥75 kg randomized to LNG + piroxicam vs. LNG + placebo.
Measured: One month after consuming study drug
Test hypothesis that LNG + piroxicam will yield superior proportion of pregnancies prevented among participants using EC on the day of ovulation and post-ovulation compared to LNG + placebo.
Aim 3 statistical analyses will use superiority design to test the hypothesis that LNG + piroxicam will yield superior proportion of pregnancies prevented among participants using EC on the day of ovulation and post-ovulation compared to LNG + placebo.
Measured: One month after consuming study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startMar 2027 (estimated)
- Primary completionJun 2031 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency ContraceptionStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A recent study in Hong Kong tested a combination of levonorgestrel and piroxicam pills for emergency contraception and found a pregnancy rate of 0.2%, an order of magnitude more effective than the most commonly used U.S. method of emergency contraception, levonorgestrel alone. This randomized controlled trial will test oral levonorgestrel + piroxicam vs. levonorgestrel + placebo for emergency contraception in a representative U.S. population that has higher pregnancy risk than in the prior study because of higher weights, different intercourse patterns, and different clinic accessibility. Data from this project will inform clinical practice in the U.S. and beyond for those desiring the most effective method of emergency contraception pills.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,458 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Turok, MD, MPH, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449299
- Sponsor's protocol ID
- 00180510
- Acronym
- RAPPEL
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel
- ClinicalTrials.gov ID
- NCT07449299
- Acronym / sponsor ID
- RAPPEL / 00180510
- Conditions
- Emergency Contraception, Contraception, COX-2 Inhibitor
- Keywords
- Emergency Contraception, Piroxicam, Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,458 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 4 Mar 2026 (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.
This randomized controlled trial will test oral levonorgestrel + piroxicam vs. levonorgestrel + placebo for emergency contraception in a representative U.S. population that has higher pregnancy risk than in the prior study because of higher weights, different intercourse patterns, and different clinic accessibility. Data from this project will inform clinical practice in the U.S. and beyond for those desiring the most effective method of emergency contraception pills.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A recent study in Hong Kong tested a combination of levonorgestrel and piroxicam pills for emergency contraception and found a pregnancy rate of 0.2%, an order of magnitude more effective than the most commonly used U.S. method of emergency contraception, levonorgestrel alone. This randomized controlled trial will test oral levonorgestrel + piroxicam vs. levonorgestrel + placebo for emergency contraception in a representative U.S. population that has higher pregnancy risk than in the prior study because of higher weights, different intercourse patterns, and different clinic accessibility. Data from this project will inform clinical practice in the U.S. and beyond for those desiring the most effective method of emergency contraception pills.
| Arm | Type | Receives |
|---|---|---|
| Oral LNG + Piroxicam | Experimental | Drug: Levonorgestrel 1.5 mg and Piroxicam 40 mgCompare EC efficacy among 1,458 U.S. participants randomly assigned 3:1 to oral LNG + piroxicam vs. oral LNG + placebo. This ARM will provide participants Oral LNG plus Piroxicam. |
| Oral LNG + Placebo | Placebo comparator | Drug: Oral LNG + PlaceboCompare EC efficacy among 1,458 U.S. participants randomly assigned 3:1 to oral LNG + piroxicam vs. oral LNG + placebo. This Arm will assign participants to oral lng plus a placebo. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Between 16-35 years old and desire LNG for EC
- Unprotected intercourse within 72 hours
- Biologically capable of pregnancy
- Regular menstrual cycle 21-35 days long with known LMP +/- 3 days
- Working cell phone number that receives text messages (for Aim 3 participants phone with capability to download and use the Oova application and submit data)
Key exclusion criteria (8 listed)
- Current pregnancy (+urine pregnancy test in clinic)
- History of stroke, myocardia infarction, ischemic heart disease, uncontrolled hypertension, congestive heart failure, peptic ulcer disease, renal or hepatic failure. Currently taking anticoagulants, corticosteroids, cyclosporine, lithium, methotrexate, or tacrolimus.
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 |
|---|---|---|
| Levonorgestrel 1.5 mg and Piroxicam 40 mgThe study intervention is a combination of Levonorgestrel 1.5 mg and Piroxicam 40 mg for emergency contraception. Participants will be randomized 3:1 to this vs. Levonorgestrel 1.5 mg and placebo. | Drug | Oral LNG + Piroxicam |
| Oral LNG + PlaceboThe study intervention is a combination of Levonorgestrel 1.5 mg and placebo for emergency contraception. Participants will be randomized 3:1 to Levonorgestrel 1.5 mg and Piroxicam vs. this option. | Drug | Oral LNG + Placebo |
Primary outcome
EC efficacy between the two study groups measured by pregnancy status four weeks after EC use.
Time frame: One month after consuming study drug
The study's primary outcome is a confirmed pregnancy at four weeks (+/- 5 days) after EC study drug consumption as determined by a positive high sensitivity urine pregnancy test or clinical documentation of a pregnancy at any time that dates back to a fertilization date that is within 5 days of EC study drug consumption.
2 secondary outcomes
Pregnancy risk for participants weighing ≥75 kg compared between the two drug treatment groups.
Time frame: One month after consuming study drug
Test hypothesis that LNG + piroxicam will yield superior proportion of pregnancies prevented among participants using EC on the day of ovulation and post-ovulation compared to LNG + placebo.
Time frame: One month after consuming study drug.
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 4 Mar 2026.
- Background: 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: No
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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.
David Turok, MD, MPH principal investigator
University of Utah
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levonorgestrel 1.5 mg and Piroxicam 40 mg in people with Emergency Contraception and Contraception, run by University of Utah.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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 David Turok, MD, MPH (801-213-2995, david.turok@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EC efficacy between the two study groups measured by pregnancy status four weeks after EC use. (time frame: One month after consuming study drug). 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 NCT07449299, 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 4 Mar 2026.