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Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel

NCT07449299 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1458

Last updated 2026-03-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • David Turok, MD, MPH · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-31
Primary Completion
2031-06-30
Completion
2031-11-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07449299 on ClinicalTrials.gov