RecruitingPhase 4NCT06861920

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

Targeting Interindividual Variability in NSAID Responses to Mitigate Chronic Pelvic Pain Risk in Dysmenorrhea (NSAID HEAL)


Sponsor

Endeavor Health

Enrollment

600 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 35 Years

Inclusion Criteria3

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

Exclusion Criteria31

  • 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.)

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Interventions

DRUGNaproxen Sodium 550mg

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.

DRUGPlacebo

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.

DRUGExtended Release Acetaminophen (650 mg)

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.


Locations(1)

Endeavor Health

Evanston, Illinois, United States

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NCT06861920


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