NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain (NSAID HEAL)

PHASE4RecruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

April 7, 2025

Primary Completion Date

April 30, 2030

Study Completion Date

July 31, 2030

Conditions
DysmenorrheaChronic Pelvic PainPelvic Pain
Interventions
DRUG

Naproxen Sodium 550mg

Participants will receive Naproxen Sodium 550 mg oral tablet, administered twice daily for the first 48 hours of their menstrual period, for 1-year. Naproxen Sodium is a nonsteroidal anti-inflammatory drug (NSAID) used for pain relief and inflammation reduction. 550 mg naproxen sodium is the highest FDA-approved starting dosage, equivalent to 500 mg naproxen; the sodium formulation quickens absorption.

DRUG

Placebo

Participants will receive a placebo oral tablet, identical in appearance to Drug X, administered twice daily for the first 48 hours of their menstrual period, for 1-year. The placebo contains inactive ingredients with no known therapeutic effect.

DRUG

Extended Release Acetaminophen (650 mg)

Participants may take extended release acetaminophen 650mg oral tablet as needed for breakthrough menstrual pain. Participants will be instructed to take 1 dose of acetaminophen after 2 hours of taking a dose of either naproxen sodium or placebo, only if needed for pain relief. They are able to take an additional dose of acetaminophen after 2 more hours have elapsed for continued breakthrough symptoms. Use of rescue medication will be monitored and recorded.

Trial Locations (1)

60201

RECRUITING

Endeavor Health, Evanston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

University of Chicago

OTHER

collaborator

University of Oklahoma

OTHER

lead

Endeavor Health

OTHER