DysmenorrheaPhase 4NSAIDHEALNCT06861920
NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain (NSAID HEAL)
A Phase 4 study testing Naproxen Sodium 550mg and Extended Release Acetaminophen (650 mg) in people with Dysmenorrhea and Chronic Pelvic Pain, run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Dysmenorrhea, Chronic Pelvic Pain, Pelvic Pain
- What is being tested?
- Naproxen Sodium 550mg and Extended Release Acetaminophen (650 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2025to Jul 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-35
- individuals who menstruate, with painful periods
- regular menstrual cycles (every 22-35 days)
Who cannot join
- presence of active pelvic or abdominal malignancies (primary or metastatic)
- conditions associated with the absence of regular menses such as polycystic ovarian syndrome, pregnancy, or any current use of continuous hormonal medication or contraceptive
- unable to read or comprehend the informed consent in English
- presence of other diagnosed chronic back or pelvic pain conditions (including chronic back pain, fibromyalgia, bladder pain syndrome, irritable bowel syndrome, vulvar pain syndrome, and endometriosis-associated pelvic pain)
- having another diagnosed/symptomatic chronic pain condition besides migraines with an average pain score >3/10 in the last month when not consuming pain relievers, or that requires daily treatment with opioids (ex. hydrocodone, oxycodone, codeine, morphine, hydromorphone, tapentadol, tramadol) or neuromodulators (also known sometimes as antidepressants [ex. amitriptyline, nortriptyline, imipramine, duloxetine, milnacipran, venlafaxine] or antiseizure medications [ex. topiramate, gabapentin, pregabalin, carbamazepine, lamotrigine])
- current or past history of stomach ulcers
Show all 31Show fewer
- current or past history of gastrointestinal (GI) bleeding
- diagnosis of peptic ulcer disease
- current or past history of renal disorders
- current or past history of adrenal dysfunction
- diagnosis of liver disorders
- diagnosis of chronic acid reflex (i.e. GERD)
- Diagnosis of Crohn's disease or ulcerative colitis
- Coagulopathy
- Prolactinoma
- Von Willebrand disease
- Platelet disorders
- High blood pressure that is difficult to manage
- gastrointestinal conditions or surgeries that affect naproxen absorption
- bleeding disorders
- heart failure
- a history of stroke
- a history of heart attack
- active genitourinary or sexually transmitted infection
- allergy to non-steroidal anti-inflammatory drugs (NSAIDs) or their ingredients
- individuals who take the following medications: anticoagulants (i.e. warfarin), lithium, diuretics, antacids, angiotensin-converting enzyme (ACE) inhibitors, methotrexate, cholestyramine, or probenecids.
- Unmanaged diabetes (i.e. Fasting Blood Glucose: ≥ 126 mg/dL (≥ 7.0 mmol/L), Non-Fasting/Random Blood Glucose: ≥ 200 mg/dL (≥ 11.1 mmol/L), Hemoglobin A1c (HbA1c): ≥ 6.5%)
- Uncontrolled thyroid function (i.e. Hypothyroidism (Underactive Thyroid): Thyroid-Stimulating Hormone (TSH): > 4.5 mIU/L (mild) or > 10 mIU/L (severe) Free T4: Below the lower end of the reference range (usually < 0.9 ng/dL)
- Hyperthyroidism (overactive thyroid) (i.e. TSH: < 0.4 mIU/L (Suppressed or undetectable), Free T4: Above the upper end of the reference range (usually > 2.0 ng/dL)
- Liver dysfunction (i.e. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or bilirubin (unless known diagnosis of Gilbert's syndrome) ≥ 1.5 times the upper limit of the reference range)
- Kidney dysfunction (i.e. Serum creatinine > 1.1 mg/dL.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Kevin Hellman, PhD
Frank Tu, MD, MPH
About this study
Official title: Targeting Interindividual Variability in NSAID Responses to Mitigate Chronic Pelvic Pain Risk in Dysmenorrhea (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 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?
Read more
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
- Conditions
- Dysmenorrhea, Chronic Pelvic Pain, Pelvic Pain
- Being tested
- Naproxen Sodium 550mg, Placebo, Extended Release Acetaminophen (650 mg)
- Keywords
- Painful Periods, NSAIDs, Chronic Pelvic Pain, Pelvic Pain, Periods
- Medical subject headings
- Dysmenorrhea, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen Sodium 550mgDrug
Also called Aleve
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.
PlaceboDrug
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.
Extended Release Acetaminophen (650 mg)Drug
Also called Tylenol
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Drug Paradigm | Active comparator | Participants in this arm will be given naproxen sodium (550mg) as the study treatment, along with extended release acetaminophen (650mg) as a rescue medication. Participants are instructed to take 1 dose of naproxen sodium every 12 hours during the first 48 hours of their menstrual period. If participants do not feel adequate pain relief within 2 hours of taking a dose of naproxen sodium, they can take 1 dose of acetaminophen; they can repeat this process again in another 2 hours if needed for pain relief. Participants are instructed to follow this regime during each menstrual period for 1-year. Participants will not know whether or not they have received naproxen sodium or placebo, but they will know that they have been give acetaminophen as an optional rescue medication. Receives: Drug: Naproxen Sodium 550mg; Drug: Extended Release Acetaminophen (650 mg) |
| Placebo Paradigm | Placebo comparator | Participants in this arm will be given a placebo capsule that is visually identical to the active drug as the study treatment, along with extended release acetaminophen (650mg) as a rescue medication. Participants are instructed to take 1 dose of the placebo every 12 hours during the first 48 hours of their menstrual period. If participants do not feel adequate pain relief within 2 hours of taking a dose of the placebo, they can take 1 dose of acetaminophen; they can repeat this process again in another 2 hours if needed for pain relief. Participants are instructed to follow this regime during each menstrual period for 1-year. Participants will not know whether or not they have received naproxen sodium or placebo, but they will know that they have been give acetaminophen as an optional rescue medication. Receives: Drug: Placebo; Drug: Extended Release Acetaminophen (650 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
M1 = Non-Menstrual Pelvic Pain (NMPP) Mediation by Menstrual Pain
"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.
Measured: From enrollment to end of treatment at 1-year
V1= Non-Menstrual Pelvic Pain (NMPP) mediation by Visceral-Visceral Convergence (VVC)
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.
Measured: From enrollment to end of treatment at 1-year
Change in Non-Menstrual Pelvic Pain (NMPP) adjusted for holistic factors
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.
Measured: From enrollment to end of treatment at 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start7 Apr 2025
- Primary completionApr 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Chicago, University of Oklahoma
- Responsible party
- Principal investigator, Kevin Hellman, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861920
- Sponsor's protocol ID
- STUDY00000081
- Other IDs
- R01HD116714
- Acronym
- NSAIDHEAL
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share these HEAL common Data Elements (CDEs): 1. Pain Intensity (PEG), 2. PROMIS Pain Interference, 3. PROMIS Physical functioning/quality of life, 4. PROMIS Sleep, 5. Pain catastrophizing (Sullivan 1995), 6. PROMIS Depression, 7. PROMIS Anxiety, 8. Global Satisfaction with Treatment (PGIC), 9. Substance Abuse (TAPS 1). The investigators will also share these HEAL-recommended demographics: age, sex at birth, gender identity, ethnicity, race, highest level of education, employment status, relationship status, annual household income, applied for disability insurance, pain duration, and postal code. The investigators will also share several data elements that lack a unified standard.
Publications
Tu FF, Datta A, Atashroo D, Senapati S, Roth G, Clauw DJ, Hellman KM. Clinical profile of comorbid dysmenorrhea and bladder sensitivity: a cross-sectional analysis. Am J Obstet Gynecol. 2020 Jun;222(6):594.e1-594.e11. doi: 10.1016/j.ajog.2019.12.010. Epub 2019 Dec 20.
PubMed 31870730Hellman KM, Roth GE, Dillane KE, Garrison EF, Oladosu FA, Clauw DJ, Tu FF. Dysmenorrhea subtypes exhibit differential quantitative sensory assessment profiles. Pain. 2020 Jun;161(6):1227-1236. doi: 10.1097/j.pain.0000000000001826.
PubMed 32168005Kmiecik MJ, Tu FF, Silton RL, Dillane KE, Roth GE, Harte SE, Hellman KM. Cortical Mechanisms of Visual Hypersensitivity in Women at Risk for Chronic Pelvic Pain. medRxiv [Preprint]. 2021 Jan 18:2020.12.03.20242032. doi: 10.1101/2020.12.03.20242032.
PubMed 33501463Shlobin AE, Tu FF, Sain CR, Kmiecik MJ, Kantarovich D, Singh L, Wang CE, Hellman KM. Bladder Pain Sensitivity Is a Potential Risk Factor for Irritable Bowel Syndrome. Dig Dis Sci. 2023 Jul;68(7):3092-3102. doi: 10.1007/s10620-023-07868-7. Epub 2023 Mar 7.
PubMed 36879177Kmiecik MJ, Tu FF, Clauw DJ, Hellman KM. Multimodal hypersensitivity derived from quantitative sensory testing predicts pelvic pain outcome: an observational cohort study. Pain. 2023 Sep 1;164(9):2070-2083. doi: 10.1097/j.pain.0000000000002909. Epub 2023 Apr 27.
PubMed 37226937
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Interindividual Variability in NSAID Responses to Mitigate Chronic Pelvic Pain Risk in Dysmenorrhea (NSAID HEAL)
- ClinicalTrials.gov ID
- NCT06861920
- Acronym / sponsor ID
- NSAIDHEAL / STUDY00000081
- Conditions
- Dysmenorrhea, Chronic Pelvic Pain, Pelvic Pain
- Keywords
- Painful Periods, NSAIDs, Chronic Pelvic Pain, Pelvic Pain, Periods
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Chicago, University of Oklahoma
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Drug Paradigm | Active comparator | Drug: Naproxen Sodium 550mg, Drug: Extended Release Acetaminophen (650 mg)Participants in this arm will be given naproxen sodium (550mg) as the study treatment, along with extended release acetaminophen (650mg) as a rescue medication. Participants are instructed to take 1 dose of naproxen sodium every 12 hours during the first 48 hours of their menstrual period. If participants do not feel adequate pain relief within 2 hours of taking a dose of naproxen sodium, they can take 1 dose of acetaminophen; they can repeat this process again in another 2 hours if needed for pain relief. Participants are instructed to follow this regime during each menstrual period for 1-year. Participants will not know whether or not they have received naproxen sodium or placebo, but they will know that they have been give acetaminophen as an optional rescue medication. |
| Placebo Paradigm | Placebo comparator | Drug: Placebo, Drug: Extended Release Acetaminophen (650 mg)Participants in this arm will be given a placebo capsule that is visually identical to the active drug as the study treatment, along with extended release acetaminophen (650mg) as a rescue medication. Participants are instructed to take 1 dose of the placebo every 12 hours during the first 48 hours of their menstrual period. If participants do not feel adequate pain relief within 2 hours of taking a dose of the placebo, they can take 1 dose of acetaminophen; they can repeat this process again in another 2 hours if needed for pain relief. Participants are instructed to follow this regime during each menstrual period for 1-year. Participants will not know whether or not they have received naproxen sodium or placebo, but they will know that they have been give acetaminophen as an optional rescue medication. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 18-35
- individuals who menstruate, with painful periods
- regular menstrual cycles (every 22-35 days)
Key exclusion criteria (31 listed)
- presence of active pelvic or abdominal malignancies (primary or metastatic)
- conditions associated with the absence of regular menses such as polycystic ovarian syndrome, pregnancy, or any current use of continuous hormonal medication or contraceptive
- unable to read or comprehend the informed consent in English
- presence of other diagnosed chronic back or pelvic pain conditions (including chronic back pain, fibromyalgia, bladder pain syndrome, irritable bowel syndrome, vulvar pain syndrome, and endometriosis-associated pelvic pain)
- having another diagnosed/symptomatic chronic pain condition besides migraines with an average pain score >3/10 in the last month when not consuming pain relievers, or that requires daily treatment with opioids (ex. hydrocodone, oxycodone, codeine, morphine, hydromorphone, tapentadol, tramadol) or neuromodulators (also known sometimes as antidepressants [ex. amitriptyline, nortriptyline, imipramine, duloxetine, milnacipran, venlafaxine] or antiseizure medications [ex. topiramate, gabapentin, pregabalin, carbamazepine, lamotrigine])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naproxen Sodium 550mgAlso: AleveParticipants 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 | Active Drug Paradigm |
| PlaceboParticipants 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 | Placebo Paradigm |
| Extended Release Acetaminophen (650 mg)Also: TylenolParticipants 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. | Drug | Active Drug Paradigm, Placebo Paradigm |
Primary outcome
M1 = Non-Menstrual Pelvic Pain (NMPP) Mediation by Menstrual Pain
Time frame: 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.
V1= Non-Menstrual Pelvic Pain (NMPP) mediation by Visceral-Visceral Convergence (VVC)
Time frame: 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.
Change in Non-Menstrual Pelvic Pain (NMPP) adjusted for holistic factors
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 31870730Tu FF, Datta A, Atashroo D, Senapati S, Roth G, Clauw DJ, Hellman KM. Clinical profile of comorbid dysmenorrhea and bladder sensitivity: a cross-sectional analysis. Am J Obstet Gynecol. 2020 Jun;222(6):594.e1-594.e11. doi: 10.1016/j.ajog.2019.12.010. Epub 2019 Dec 20.
- Background: PubMed 32168005Hellman KM, Roth GE, Dillane KE, Garrison EF, Oladosu FA, Clauw DJ, Tu FF. Dysmenorrhea subtypes exhibit differential quantitative sensory assessment profiles. Pain. 2020 Jun;161(6):1227-1236. doi: 10.1097/j.pain.0000000000001826.
- Background: PubMed 33501463Kmiecik MJ, Tu FF, Silton RL, Dillane KE, Roth GE, Harte SE, Hellman KM. Cortical Mechanisms of Visual Hypersensitivity in Women at Risk for Chronic Pelvic Pain. medRxiv [Preprint]. 2021 Jan 18:2020.12.03.20242032. doi: 10.1101/2020.12.03.20242032.
- Background: PubMed 36879177Shlobin AE, Tu FF, Sain CR, Kmiecik MJ, Kantarovich D, Singh L, Wang CE, Hellman KM. Bladder Pain Sensitivity Is a Potential Risk Factor for Irritable Bowel Syndrome. Dig Dis Sci. 2023 Jul;68(7):3092-3102. doi: 10.1007/s10620-023-07868-7. Epub 2023 Mar 7.
- Background: PubMed 37226937Kmiecik MJ, Tu FF, Clauw DJ, Hellman KM. Multimodal hypersensitivity derived from quantitative sensory testing predicts pelvic pain outcome: an observational cohort study. Pain. 2023 Sep 1;164(9):2070-2083. doi: 10.1097/j.pain.0000000000002909. Epub 2023 Apr 27.
- NSAID HEAL websiteLink provided by the sponsor.
- Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators will share these HEAL common Data Elements (CDEs): 1. Pain Intensity (PEG), 2. PROMIS Pain Interference, 3. PROMIS Physical functioning/quality of life, 4. PROMIS Sleep, 5. Pain catastrophizing (Sullivan 1995), 6. PROMIS Depression, 7. PROMIS Anxiety, 8. Global Satisfaction with Treatment (PGIC), 9. Substance Abuse (TAPS 1). The investigators will also share these HEAL-recommended demographics: age, sex at birth, gender identity, ethnicity, race, highest level of education, employment status, relationship status, annual household income, applied for disability insurance, pain duration, and postal code. The investigators will also share several data elements that lack a unified standard.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen Sodium 550mg and Extended Release Acetaminophen (650 mg) in people with Dysmenorrhea and Chronic Pelvic Pain, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Hellman, PHD (773-338-1710, khellman@northshore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M1 = Non-Menstrual Pelvic Pain (NMPP) Mediation by Menstrual Pain (time frame: From enrollment to end of treatment at 1-year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06861920, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.