Trial · NCT06861920
NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain (NSAID HEAL)
NCT06861920, Phase 4, Recruiting, Endeavor Health
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain (NSAID HEAL). Trials, record NCT06861920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06861920
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain (NSAID HEAL)
- NCT number
- NCT06861920
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 600 participants, estimated
- Lead sponsor
- Endeavor Health
- Conditions
- Dysmenorrhea, Chronic Pelvic Pain, Pelvic Pain
- Interventions
- Naproxen Sodium 550mg, Placebo, Extended Release Acetaminophen (650 mg)
- First posted
- 2025-03-06
- Last updated
- 2025-08-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | M1 = Non-Menstrual Pelvic Pain (NMPP) Mediation by Menstrual Pain | From enrollment to end of treatment at 1-year | "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 levels). The mediation effect (M1) will be quantified using standardized path coefficients and indirect effects with bootstrapped 95% confidence intervals to determine the proportion of the NSAID effect on NMPP reduction. This outcome ranges from -1 to +1, with positive values indicating a worsening and negative values indicating a better mediation outcome. |
| Primary | V1= Non-Menstrual Pelvic Pain (NMPP) mediation by Visceral-Visceral Convergence (VVC) | From enrollment to end of treatment at 1-year | In a structural equation model, VVC (bladder pain at first urge on 0-100 visual analog scale) and Multimodal Hypersensitivity) (reflecting widespread increased experimental sensitivity during the visual task, audio task, pressure pain tests, cold pressor, and conditioned pain modulation) will be constructed as a latent variable) mediation of the effect of NSAIDS on reductions in NMPP using a structural equation model. The mediation effect (V1) will be quantified using standardized path coefficients and indirect effects with bootstrapped 95% confidence intervals to determine the proportion of the VVC effect on NMPP. This outcome ranges from -1 to +1, with positive values indicating an worsening outcome and negative values indicating a better outcome. |
| Primary | Change in Non-Menstrual Pelvic Pain (NMPP) adjusted for holistic factors | From enrollment to end of treatment at 1-year | Non-menstrual pelvic pain (NMPP) will be measured 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. Change in NMPP over time will be modeled using Structural Equation Modeling, adjusting for uterine inflammation (effluent prostaglandin concentration), sex hormones (estradiol, progesterone), and psychosocial factors (anxiety, depression, stress, sleep). The change in NMPP will be reported on a -10 to +10 scale, where -10 indicates improvement and +10 indicates worsening. |
| Other | Trial effects of NSAIDs on Non-Menstrual Pelvic Pain (NMPP) | From enrollment to end of treatment at 1-year | The impact of NSAIDs on non-menstrual pelvic pain (NMPP) will be assessed by comparing participants using NSAIDs to those on placebo. Treatment effects will be measured as the difference in NMPP scores between the NSAID and placebo groups over time (Baseline, 4, 8, and 12 months) using electronic daily diaries. NMPP will be recorded on a 0-10 scale, where 0 indicates no pain (better outcome) and 10 indicates severe pain (worse outcome) |
| Other | Trial effects of NSAIDs on chronic pelvic pain | From enrollment to end of treatment at 1-year | The impact of NSAIDs on chronic pelvic pain (CPP) will be assessed by comparing participants using NSAIDs to those on placebo. Treatment effects will be measured by the proportion of participants meeting diagnostic criteria for CPP based on electronic daily diaries at Baseline, 4, 8, and 12 months. CPP status will be reported as a percentage, where 0% indicates no CPP (best outcome) and 100% indicates all participants meeting CPP criteria (worst outcome). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD116714 | Targeting Interindividual Variability in NSAID Responses to Mitigate Chronic Pelvic Pain Risk in Dysmenorrhea | HELLMAN, KEVIN | ENDEAVOR HEALTH CLINICAL OPERATIONS | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2024 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06861920
GET https://conductscience.org/api/trials/v1/NCT06861920/registered