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NCT Number: NCT07449299

Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel

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.

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Key information

Conditions

Emergency Contraception COX-2 Inhibitor Contraception

Age range

16 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 + 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.

Primary outcomes

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

    Time frame: One month after consuming study drug

    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.

Secondary outcomes

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

    Time frame: One month after consuming study drug

    The primary outcome for this aim will be the pregnancy risk for participants weighing ≥75 kg compared between the two drug treatment groups. We will compare the pregnancy risk among the subset of participants weighing ≥75 kg randomized to LNG + piroxicam vs. LNG + placebo.

  2. 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.

    Time frame: One month after consuming study drug.

    Aim 3 statistical analyses will use superiority design to test the 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Turok, MD, MPH

CONTACT

[email protected]

801-213-2995

Sarah DeLuca, MPH

CONTACT

[email protected]

801-213-2995

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Acronym: RAPPEL

Important dates

Study start
2027
Primary completion
2031
Study completion
2031
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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