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NCT06861920 · ClinicalTrials.gov registry record · Phase 4
NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain (NSAID HEAL)
A Phase 4 study of Pelvic Pain and Chronic Pelvic Pain, sponsored by Endeavor Health.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 600
- Enrollment target
- 1
- Study location
NCT06861920: Recruiting Phase 4 study of Pelvic Pain and Chronic Pelvic Pain, sponsored by Endeavor Health.
NCT06861920 is a Phase 4 study of Pelvic Pain and Chronic Pelvic Pain that is actively recruiting participants, run by Endeavor Health. The registered enrollment target is 600 participants, above the 346-participant average among 23 other Pelvic Pain trials with a reported enrollment target (73% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06861920, a Phase 4 study of Pelvic Pain and Chronic Pelvic Pain, is actively recruiting participants, sponsored by Endeavor Health.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 600 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
"Non-menstrual pelvic pain (NMPP) will be assessed as the average of bladder, bowel, and non-menstrual pelvic pain ratings (0-10 scale) on non-bleeding days, excluding the two days before menstruation. Daily menstrual pain will be recorded during Menses (0-10 scale). The primary outcome is the reduction in NMPP at cycles 3,6,9, and 12, modeled using structural equation modeling to examine mediation by menstrual pain response to NSAIDs, accounting for endometrial inflammation (effluent cytokine l
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Naproxen Sodium 550mg
- DRUG Extended Release Acetaminophen (650 mg)
Study Locations (1)
Illinois
- Endeavor Health - Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2025-04-07 |
| Est. Completion | 2030-07 |
| Phase | Phase 4 |
What NCT06861920 shows while recruiting
NCT06861920 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 346-participant average among 23 other Pelvic Pain trials with a reported enrollment target (73% higher).
The record links to 3 conditions, with Pelvic Pain appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06861920 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06861920 about?
NCT06861920 is a clinical study titled "NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain (NSAID HEAL)". 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 m...
What is the current status of trial NCT06861920?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 600 participants. The study started on 2025-04-07. Estimated completion is 2030-07.
What conditions does trial NCT06861920 study?
This clinical trial studies the following conditions: Pelvic Pain, Chronic Pelvic Pain, Dysmenorrhea.
What interventions are being tested in trial NCT06861920?
The interventions under investigation include: Placebo (DRUG), Naproxen Sodium 550mg (DRUG), Extended Release Acetaminophen (650 mg) (DRUG).
Who is sponsoring clinical trial NCT06861920?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06861920 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06861920's enrollment target sits among peer trials
600 4th of 23 higher than 20 of 23 other Pelvic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pelvic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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