| Registry | NCT07449299, acronym RAPPEL |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 1458 (Estimated) |
| Sponsor | University of Utah (Other) |
| Conditions | Emergency Contraception, Contraception, COX-2 Inhibitor |
| Interventions | Levonorgestrel 1.5 mg and Piroxicam 40 mg, Oral LNG + Placebo (Drug) |
| Dates | start 2027-03-01 (estimated), primary completion 2031-06-01 (estimated), completion 2031-11-01 (estimated), first posted 2026-03-04, last updated 2026-03-04 |
Related Papers Related Patents Related Grants Related Experts
All trials for Emergency Contraception All trials for Contraception All trials of Levonorgestrel 1.5 mg and Piroxicam 40 mg All trials of Oral LNG + Placebo
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 | Interventions | Description |
|---|---|---|---|
| Oral LNG + Piroxicam | Experimental | Drug: Levonorgestrel 1.5 mg and Piroxicam 40 mg | 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. |
| Oral LNG + Placebo | Placebo comparator | Drug: Oral LNG + Placebo | 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. |
Sex: Female, ages: 16 Years to 35 Years
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 or hepatic failure. Currently taking anticoagulants, corticosteroids, cyclosporine, lithium, methotrexate, or tacrolimus.