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NSAID HEAL: Naproxen for Menstrual Pain and Chronic Pelvic Pain

This study, called NSAID HEAL, is looking at whether naproxen sodium (an NSAID, or nonsteroidal anti-inflammatory drug, like ibuprofen) can help treat painful periods (dysmenorrhea) and prevent chronic pelvic pain. Researchers want to see if reducing menstrual pain with naproxen sodium can also lead to less non-menstrual pelvic pain. You would take either naproxen sodium 550mg or a placebo (an inactive pill that looks the same) twice a day for the first two days of your period, every month for one year. You can also take extended-release acetaminophen for breakthrough pain. The study is for women aged 18-35 who have regular, painful periods. The goal is to understand if naproxen sodium works better than a placebo to reduce pain.

Study design
This is an interventional study comparing naproxen sodium to a placebo. It plans to enroll 600 participants.
What's involved
You would take either naproxen sodium or a placebo twice daily for the first 48 hours of your menstrual period, for one year.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured from enrollment to the end of treatment at 1-year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06861920

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

Recruiting
PHASE4Ages 18–35InterventionalTreatment
Endeavor Health
~600 participants
Updated 2025-08-07 on ClinicalTrials.gov
What's tested:Naproxen Sodium 550mgPlaceboExtended Release Acetaminophen (650 mg)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
M1 = Non-Menstrual Pelvic Pain (NMPP) Mediation by Menstrual Pain
Measured over From enrollment to end of treatment at 1-year
+2 more outcomes measured

Conditions

Dysmenorrhea
Chronic Pelvic Pain
Pelvic Pain

Explore related trials

DysmenorrheaPelvic Pain

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Kevin Hellman, PHD
[email protected]
773-338-1710
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

aged 18-35
individuals who menstruate, with painful periods
regular menstrual cycles (every 22-35 days)

Exclusion

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
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.)

What this trial measures

  • M1 = Non-Menstrual Pelvic Pain (NMPP) Mediation by Menstrual PainFrom 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)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 factorsFrom 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.