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New treatment option for Dysmenorrhea
Official title NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain (NSAID HEAL)
ClinicalTrials.gov ID: NCT06861920
What this study is testing
What is Naproxen Sodium 550mg?
Naproxen Sodium 550mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for dysmenorrhea.
Also referred to as Aleve.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35, women only
You may be able to join if
- aged 18-35
- individuals who menstruate, with painful periods
- regular menstrual cycles (every 22-35 days)
You likely can't join if
- 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...
- 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...
- having another diagnosed/symptomatic chronic pain condition besides migraines with an average pain score \>3/10 in the last month when not consuming...
- current or past history of stomach ulcers
See the full eligibility criteria
- aged 18-35
- individuals who menstruate, with painful periods
- regular menstrual cycles (every 22-35 days)
- 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...
- 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...
- 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 \<...
- Hyperthyroidism (overactive thyroid) (i.e. TSH: \ 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.)
The study team makes the final eligibility decision.
Where it's taking place
- Evanston, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Evanston, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.