NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain

Launched by ENDEAVOR HEALTH · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called naproxen sodium can help relieve menstrual pain and potentially prevent chronic pelvic pain in women aged 18 to 35 who experience painful periods. Researchers want to understand if how well naproxen works for menstrual pain can predict its effectiveness for pelvic pain that occurs at other times. Participants will take either naproxen or a placebo (a sugar pill with no active drug) during their menstrual periods for one year. They will also fill out questionnaires and take hormone tests at home, and they will visit the research site twice during the year for additional assessments.

To be eligible for the study, participants must be menstruating women aged 18 to 35 with regular menstrual cycles and painful periods. However, those with certain medical conditions, such as active pelvic diseases, gastrointestinal issues, or specific chronic pain conditions, will not be able to participate. This trial aims to gather important information that could help improve treatment for menstrual and pelvic pain in the future.

Gender

FEMALE

Eligibility 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.)