Using Naproxen Sodium to Treat Painful Periods and Prevent Chronic Pelvic Pain in Women Ages 18 to 35

What this Trial Is About

Researchers are investigating whether NSAIDs, specifically naproxen sodium, can effectively treat menstrual pain and prevent the development of chronic pelvic pain in adult women who experience painful periods. The study aims to understand if reductions in menstrual pain predict lower non-menstrual pelvic pain and whether decreases in multi-site sensitivity after NSAID treatment relate to pain outcomes. This Phase 4 trial will compare naproxen sodium with a placebo to evaluate its impact on dysmenorrhea and chronic pelvic pain risk. Participants will be randomly assigned to receive either naproxen sodium 550 mg or a placebo twice daily during the first 48 hours of their menstrual period each month for one year. They may also take extended release acetaminophen 650 mg as needed for breakthrough pain, following specific dosing guidelines. Neither participants nor researchers will know who receives the active drug or placebo, but acetaminophen use will be allowed and monitored as rescue medication. During the study, participants will complete computerized questionnaires and tests from home every three months and perform hormone urine tests every few days for the year. They will collect small blood and menstrual blood samples twice during the year and visit the research site twice for sensory assessments and blood draws. Researchers will measure changes in non-menstrual pelvic pain and related factors over the treatment year to develop a model describing pain medication effectiveness and chronic pain risk.

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