NCT07449299

Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,458 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: Female
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emergency Contraception
• Contraception
• COX-2 Inhibitor

Interventions

Type	Name	Description
DRUG	Levonorgestrel 1.5 mg and Piroxicam 40 mg	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.
DRUG	Oral LNG + Placebo	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.

Timeline

• Start date: 2027-03-01
• Primary completion: 2031-06-01
• Completion: 2031-11-01
• First posted: 2026-03-04
• Last updated: 2026-03-04

Regulatory

• FDA-regulated drug study