Not Yet RecruitingPhase 3

Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel

1,458 participantsStarted 2027-03

Plain-language 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. 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.

Who can participate

Age range

16 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

EC efficacy between the two study groups measured by pregnancy status four weeks after EC use.

Timeframe: One month after consuming study drug

Trial details

NCT IDNCT07449299

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-06

Contact for this trial

David Turok, MD, MPH

801-213-2995 david.turok@hsc.utah.edu

View on ClinicalTrials.gov More Emergency Contraception trials