Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel

NCT07449299 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 00180510
• Study Type: interventional
• Target: 1,458
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Emergency Contraception; Piroxicam; Contraception

Outcome Measures

Primary Outcomes (1)

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

  The study's primary outcome is a confirmed pregnancy at four weeks (+/- 5 days) after EC study drug consumption as determined by a positive high sensitivity urine pregnancy test or clinical documentation of a pregnancy at any time that dates back to a fertilization date that is within 5 days of EC study drug consumption.

  One month after consuming study drug

Secondary Outcomes (2)

• Pregnancy risk for participants weighing ≥75 kg compared between the two drug treatment groups.

  One month after consuming study drug

• Test hypothesis that LNG + piroxicam will yield superior proportion of pregnancies prevented among participants using EC on the day of ovulation and post-ovulation compared to LNG + placebo.

  One month after consuming study drug.

Study Arms (2)

Oral LNG + Piroxicam

EXPERIMENTAL

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.

Drug: Levonorgestrel 1.5 mg and Piroxicam 40 mg

Oral LNG + Placebo

PLACEBO COMPARATOR

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.

Drug: Oral LNG + Placebo

Interventions

Levonorgestrel 1.5 mg and Piroxicam 40 mg DRUG

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.

Oral LNG + Piroxicam

Oral LNG + Placebo DRUG

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.

Oral LNG + Placebo

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• University of Utah: lead

Related Publications (1)

• Li RHW, Lo SST, Gemzell-Danielsson K, Fong CHY, Ho PC, Ng EHY. Oral emergency contraception with levonorgestrel plus piroxicam: a randomised double-blind placebo-controlled trial. Lancet. 2023 Sep 9;402(10405):851-858. doi: 10.1016/S0140-6736(23)01240-0. Epub 2023 Aug 16.

  PMID: 37597523 BACKGROUND

MeSH Terms

Interventions

Levonorgestrel; Piroxicam

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Turok, MD, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Turok, MD, MPH

CONTACT

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

Sarah DeLuca, MPH

CONTACT

801-213-2995; sarah.deluca@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A recent study in Hong Kong tested a combination of levonorgestrel and piroxicam pills for emergency contraception and found a pregnancy rate of 0.2%, an order of magnitude more effective than the most commonly used U.S. method of emergency contraception, levonorgestrel alone. 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.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): November 1, 2031
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share