Phase
Condition
Chronic Pelvic Pain
Dysmenorrhea (Painful Periods)
Severe Premenstrual Symptom
Treatment
Placebo
Naproxen Sodium 550mg
Extended Release Acetaminophen (650 mg)
Clinical Study ID
Ages 18-35 Female
Study Summary
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
Connect with a study center
Endeavor Health
Evanston, Illinois 60201
United StatesActive - Recruiting
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