Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Emergency Contraception, Contraception, COX-2 Inhibitor

In brief

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.

Key facts

Study ID

NCT07449299

Run by

University of Utah

People needed

1458

Starts

2027-03-01

Expected to finish

2031-11-01

Last updated by the study team

2026-03-04

Who can join

Age: 16 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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