Actively Recruiting

Phase 4
Age: 18Years - 35Years
FEMALE
NCT06861920

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

Led by Endeavor Health · Updated on 2025-08-07

600

Participants Needed

1

Research Sites

273 weeks

Total Duration

On this page

Sponsors

E

Endeavor Health

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 35Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-35 years
  • Individuals who menstruate and have painful periods
  • Regular menstrual cycles occurring every 22 to 35 days
Not Eligible

You will not qualify if you...

  • Presence of active pelvic or abdominal malignancies
  • Conditions causing absence of regular menses such as polycystic ovarian syndrome, pregnancy, or current use of continuous hormonal medications or contraceptives
  • Unable to read or understand informed consent in English
  • Diagnosed chronic back or pelvic pain conditions including fibromyalgia, bladder pain syndrome, irritable bowel syndrome, vulvar pain syndrome, and endometriosis-associated pelvic pain
  • Other chronic pain conditions besides migraines with average pain >3/10 in the last month without pain relievers or requiring daily opioid or neuromodulator treatment
  • Current or past history of stomach ulcers, gastrointestinal bleeding, peptic ulcer disease, renal disorders, adrenal dysfunction, liver disorders, chronic acid reflux, Crohn's disease, or ulcerative colitis
  • Coagulopathy, prolactinoma, Von Willebrand disease, platelet disorders
  • Difficult-to-manage high blood pressure
  • Gastrointestinal conditions or surgeries affecting naproxen absorption
  • Bleeding disorders, heart failure, history of stroke or heart attack
  • Active genitourinary or sexually transmitted infections
  • Allergy to NSAIDs or their ingredients
  • Use of medications such as anticoagulants, lithium, diuretics, antacids, ACE inhibitors, methotrexate, cholestyramine, or probenecids
  • Unmanaged diabetes (specific blood glucose or HbA1c thresholds)
  • Uncontrolled thyroid function (specific TSH and Free T4 levels)
  • Liver dysfunction indicated by elevated liver enzymes or bilirubin (except Gilbert's syndrome)
  • Kidney dysfunction with serum creatinine >1.1 mg/dL

AI-Screening

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Trial Site Locations

Total: 1 location

1

Endeavor Health

Evanston, Illinois, United States, 60201

Actively Recruiting

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Research Team

K

Kevin Hellman, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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