Using NSAIDs to treat menstrual pain and prevent chronic pelvic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of naproxen sodium, a nonsteroidal anti-inflammatory drug (NSAID), in treating menstrual pain and preventing chronic pelvic pain in menstruating adults aged 18-35 with painful periods. Participants will take either naproxen sodium or a placebo during their menstrual periods for one year and will complete questionnaires and hormone tests at home. The study aims to determine if the reduction in menstrual pain can predict the reduction in non-menstrual pelvic pain and if those with the greatest sensitivity reduction will experience the most significant pain relief.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* 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.)

Where it's running

• Endeavor Health
  Evanston, Illinois, United States Recruiting

Study contacts

• Study coordinator: Kevin Hellman, PHD
• Email: khellman@northshore.org
• Phone: 773-338-1710

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.