Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06861920 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: NSAIDHEAL
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Start date changed from estimate of Apr 2025 to Apr 7, 2025
    • Study title expanded, about 2 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if NSAIDs (i.e. naproxen sodium) can treat menstrual pain and prevent the development of chronic pelvic pain in menstruating adults with painful periods. The main questions it aims to answer are: * Can non-menstrual pelvic pain reduction be predicted by menstrual pain response to NSAIDs? * Will participants with the largest reductions in multi-site sensitivity following NSAID therapy have the largest reductions in non-menstrual pelvic pain? Researchers will compare naproxen sodium to a placebo (a look-alike substance that contains no drug) to see if naproxen sodium works to treat painful periods. Participants will: * Take naproxen sodium or placebo during several days of their menstrual period every month for 1 year. * Complete computer questionnaires and tests from home every 3 months. * Complete at-home urine tests to measure hormones every few days for 1-year. * Use a pin-prick to collect a small spot of blood, and use a pad or tampon to collect a sample of menstrual blood, and bring it to the research site twice over a 1-year period. * Come to the research site twice over a 1-year period to complete sensory assessments and undergo a blood draw. The major goal of the study is to develop a multivariable statistical model (see https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-021.html ) describing the factors that effectiveness of pain medication and risk for chronic pain
Trial Details
NCT Number NCT06861920
Lead Sponsor Endeavor Health
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Chicago, University of Oklahoma
Conditions
(from sponsor)
Dysmenorrhea, Chronic Pelvic Pain, Pelvic Pain
Related terms Dysmenorrhea, Pelvic Pain
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov