Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel

Sponsor
University of Utah
Study ID
NCT07449299
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • COX-2 Inhibitor
  • Contraception
  • Emergency Contraception

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 35 Years
Healthy Volunteers
Not accepted

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 + 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.

Study Details

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.

Key Dates

First listed
Mar 4, 2026
Start date
Mar 31, 2027
Status verified
Feb 2026
Primary completion
Jun 30, 2031
Completion
Nov 30, 2031

Study Design

Enrollment
1,458 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Oral LNG + Piroxicam
    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.
  • Placebo Comparator: 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.

Primary Outcome Measure

EC efficacy between the two study groups measured by pregnancy status four weeks after EC use. [ Time Frame: One month after consuming study drug ]

Central Contacts

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