Using NSAIDs to treat menstrual pain and prevent chronic pelvic pain
Targeting Interindividual Variability in NSAID Responses to Mitigate Chronic Pelvic Pain Risk in Dysmenorrhea (NSAID HEAL)
This study is testing if taking naproxen sodium can help young adults with painful periods feel better and possibly prevent long-term pelvic pain.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Endeavor Health Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Evanston, Illinois) |
| Trial ID | NCT06861920 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are menstruating individuals aged 18-35 who experience painful periods and have regular menstrual cycles.
Not a fit: Patients with active pelvic or abdominal malignancies, other chronic pain conditions, or those on continuous hormonal medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new approach to managing menstrual pain and preventing chronic pelvic pain in young women.
How similar studies have performed: Other studies have shown positive outcomes with NSAIDs for menstrual pain, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Evanston, Illinois
- Endeavor Health — Evanston, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Kevin Hellman, PHD
- Email: khellman@northshore.org
- Phone: 773-338-1710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.