NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain

Last updated: March 5, 2025
Sponsor: Endeavor Health
Overall Status: Active - Recruiting

Phase

4

Condition

Chronic Pelvic Pain

Dysmenorrhea (Painful Periods)

Severe Premenstrual Symptom

Treatment

Placebo

Naproxen Sodium 550mg

Extended Release Acetaminophen (650 mg)

Clinical Study ID

NCT06861920
STUDY00000081
R01HD116714
  • Ages 18-35
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • aged 18-35

  • individuals who menstruate, with painful periods

  • regular menstrual cycles (every 22-35 days)

Exclusion

Exclusion Criteria:

  • presence of active pelvic or abdominal malignancies (primary or metastatic)

  • conditions associated with the absence of regular menses such as polycystic ovariansyndrome, pregnancy, or any current use of continuous hormonal medication orcontraceptive

  • unable to read or comprehend the informed consent in English

  • presence of other diagnosed chronic back or pelvic pain conditions (includingchronic 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 withan average pain score >3/10 in the last month when not consuming pain relievers, orthat requires daily treatment with opioids (ex. hydrocodone, oxycodone, codeine,morphine, hydromorphone, tapentadol, tramadol) or neuromodulators (also knownsometimes 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) FreeT4: Below the lower end of the reference range (usually < 0.9 ng/dL)

  • Hyperthyroidism (overactive thyroid) (i.e. TSH: < 0.4 mIU/L (Suppressed orundetectable), Free T4: Above the upper end of the reference range (usually > 2.0ng/dL)

  • Liver dysfunction (i.e. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or bilirubin (unless known diagnosis of Gilbert's syndrome) ≥ 1.5 times theupper limit of the reference range)

  • Kidney dysfunction (i.e. Serum creatinine > 1.1 mg/dL.)

Study Design

Total Participants: 600
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 4
Study Start date:
April 01, 2025
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • Endeavor Health

    Evanston, Illinois 60201
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.