Recruiting

NSAID

Sponsor:

Endeavor Health

Code:

NCT06861920

Conditions

Dysmenorrhea

Chronic Pelvic Pain

Pelvic Pain

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Naproxen Sodium 550mg

Placebo

Extended Release Acetaminophen (650 mg)

Study Details

Brief summary:

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. The main questions it aims to answer are:

  • Can non-menstrual pelvic pain reduction be predicted by menstrual pain response to NSAIDs?
  • Will participants with the largest reductions in multi-site sensitivity following NSAID therapy have the largest reductions in non-menstrual pelvic pain?

Researchers will compare naproxen sodium to a placebo (a look-alike substance that contains no drug) to see if naproxen sodium works to treat painful periods.

Participants will:

  • Take naproxen sodium or placebo during several days of their menstrual period every month for 1 year.
  • Complete computer questionnaires and tests from home every 3 months.
  • Complete at-home urine tests to measure hormones every few days for 1-year.
  • Use a pin-prick to collect a small spot of blood, and use a pad or tampon to collect a sample of menstrual blood, and bring it to the research site twice over a 1-year period.
  • Come to the research site twice over a 1-year period to complete sensory assessments and undergo a blood draw.

The major goal of the study is to develop a multivariable statistical model (see https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-021.html ) describing the factors that effectiveness of pain medication and risk for chronic pain

Conditions

Dysmenorrhea

Chronic Pelvic Pain

Pelvic Pain

Study ID

NCT06861920

Start date

Apr 7, 2025

Status verified date

Aug, 2025

Completion date

Jul, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active Drug Paradigm

Participants in this arm will be given naproxen sodium (550mg) as the study treatment, along with extended release acetaminophen (650mg) as a rescue medication. Participants are instructed to take 1 dose of naproxen sodium every 12 hours during the first 48 hours of their menstrual period. If participants do not feel adequate pain relief within 2 hours of taking a dose of naproxen sodium, they can take 1 dose of acetaminophen; they can repeat this process again in another 2 hours if needed for pain relief. Participants are instructed to follow this regime during each menstrual period for 1-year. Participants will not know whether or not they have received naproxen sodium or placebo, but they will know that they have been give acetaminophen as an optional rescue medication.

placebo comparator: Placebo Paradigm

Participants in this arm will be given a placebo capsule that is visually identical to the active drug as the study treatment, along with extended release acetaminophen (650mg) as a rescue medication. Participants are instructed to take 1 dose of the placebo every 12 hours during the first 48 hours of their menstrual period. If participants do not feel adequate pain relief within 2 hours of taking a dose of the placebo, they can take 1 dose of acetaminophen; they can repeat this process again in another 2 hours if needed for pain relief. Participants are instructed to follow this regime during each menstrual period for 1-year. Participants will not know whether or not they have received naproxen sodium or placebo, but they will know that they have been give acetaminophen as an optional rescue medication.

Interventions

Naproxen Sodium 550mg

Participants will receive Naproxen Sodium 550 mg oral tablet, administered twice daily for the first 48 hours of their menstrual period, for 1-year. Naproxen Sodium is a nonsteroidal anti-inflammatory drug (NSAID) used for pain relief and inflammation reduction. 550 mg naproxen sodium is the highest FDA-approved starting dosage, equivalent to 500 mg naproxen; the sodium formulation quickens absorption.

Placebo

Participants will receive a placebo oral tablet, identical in appearance to Drug X, administered twice daily for the first 48 hours of their menstrual period, for 1-year. The placebo contains inactive ingredients with no known therapeutic effect.

Extended Release Acetaminophen (650 mg)

Participants may take extended release acetaminophen 650mg oral tablet as needed for breakthrough menstrual pain. Participants will be instructed to take 1 dose of acetaminophen after 2 hours of taking a dose of either naproxen sodium or placebo, only if needed for pain relief. They are able to take an additional dose of acetaminophen after 2 more hours have elapsed for continued breakthrough symptoms. Use of rescue medication will be monitored and recorded.

Primary outcome measure

  • M1 = Non-Menstrual Pelvic Pain (NMPP) Mediation by Menstrual Pain [ Time Frame: From enrollment to end of treatment at 1-year ]
  • V1= Non-Menstrual Pelvic Pain (NMPP) mediation by Visceral-Visceral Convergence (VVC) [ Time Frame: From enrollment to end of treatment at 1-year ]
  • Change in Non-Menstrual Pelvic Pain (NMPP) adjusted for holistic factors [ Time Frame: From enrollment to end of treatment at 1-year ]

Central Contacts and Locations

Central contacts

Kevin Hellman, PHD

773-338-1710khellman@northshore.org

Locations

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

Principal Investigator:

Kevin Hellman, PhD

More Information

Sponsor

Endeavor Health

Last update posted

Aug 7, 2025

Last verified

Aug, 2025

Keywords

  • Painful Periods
  • NSAIDs
  • Chronic Pelvic Pain
  • Pelvic Pain
  • Periods

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2025-08-07.