Clinical profile of comorbid dysmenorrhea and bladder sensitivity: a cross-sectional analysis.
Frank F Tu, Avisek Datta, Diana Atashroo...
https://pubmed.ncbi.nlm.nih.gov/31870730Actively Recruiting
Phase 4
Age: 18Years - 35Years
FEMALE
ID06861920
Targeting Interindividual Variability in NSAID Responses to Mitigate Chronic Pelvic Pain Risk in Dysmenorrhea (NSAID HEAL)
Led by Endeavor Health · Updated on 2025-08-07
600
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
E
Endeavor Health
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether NSAIDs, specifically naproxen sodium, can effectively treat menstrual pain and prevent the development of chronic pelvic pain in adult women who experience painful periods. The study aims to understand if reductions in menstrual pain predict lower non-menstrual pelvic pain and whether decreases in multi-site sensitivity after NSAID treatment relate to pain outcomes. This Phase 4 trial will compare naproxen sodium with a placebo to evaluate its impact on dysmenorrhea and chronic pelvic pain risk. Participants will be randomly assigned to receive either naproxen sodium (550 mg) or a placebo twice daily during the first 48 hours of their menstrual period each month for one year. They may also take extended release acetaminophen (650 mg) as needed for breakthrough pain, following specific dosing guidelines. Neither participants nor researchers will know who receives the active drug or placebo, but acetaminophen use will be allowed and monitored as rescue medication. During the study, participants will complete computerized questionnaires and tests from home every three months and perform hormone urine tests every few days for the year. They will collect small blood and menstrual blood samples twice during the year and visit the research site twice for sensory assessments and blood draws. Researchers will measure changes in non-menstrual pelvic pain and related factors over the treatment year to develop a model describing pain medication effectiveness and chronic pain risk.
CONDITIONS
Brief Title
NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain (NSAID HEAL)
Who Can Participate
Age: 18Years - 35Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Aged 18 to 35 years
- Individuals who menstruate with painful periods
- Have regular menstrual cycles every 22 to 35 days
You will not qualify if you...
- Presence of active pelvic or abdominal cancers
- Conditions causing absence of regular menses such as polycystic ovarian syndrome, pregnancy, or continuous hormonal medication use
- Unable to understand informed consent in English
- Other diagnosed chronic back or pelvic pain conditions including fibromyalgia, bladder pain syndrome, irritable bowel syndrome, vulvar pain syndrome, and endometriosis-associated pelvic pain
- Other chronic pain conditions besides migraines with average pain score above 3/10 or requiring daily opioid or neuromodulator treatment
- History of stomach ulcers or gastrointestinal bleeding
- Diagnosis of peptic ulcer disease
- History of kidney, adrenal, or liver disorders
- Chronic acid reflux, Crohn's disease, or ulcerative colitis
- Coagulopathy, prolactinoma, Von Willebrand disease, or platelet disorders
- Difficult to manage high blood pressure
- Gastrointestinal conditions or surgeries affecting naproxen absorption
- Heart failure, stroke, or heart attack history
- Active genitourinary or sexually transmitted infections
- Allergy to NSAIDs or their ingredients
- Use of anticoagulants, lithium, diuretics, antacids, ACE inhibitors, methotrexate, cholestyramine, or probenecids
- Unmanaged diabetes or uncontrolled thyroid function
- Liver or kidney dysfunction indicated by specific lab values
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 year
Participants take either naproxen sodium or a placebo twice daily for the first 48 hours of their menstrual period, repeated during each menstrual cycle for 1 year. Participants may also take extended release acetaminophen as needed for breakthrough pain following specific instructions.
Visits scheduled around menstrual periods over 1 year to monitor treatment and pain relief
Trial Site Locations
Total: 1 location
1
Endeavor Health
Evanston, Illinois, United States, 60201
Actively Recruiting
Loading map...
Research Team
K
Kevin Hellman, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Dysmenorrhea subtypes exhibit differential quantitative sensory assessment profiles.
Kevin M Hellman, Genevieve E Roth, Katlyn E Dillane...
https://pubmed.ncbi.nlm.nih.gov/32168005Cortical Mechanisms of Visual Hypersensitivity in Women at Risk for Chronic Pelvic Pain.
Matthew J Kmiecik, Frank F Tu, Rebecca L Silton...
https://pubmed.ncbi.nlm.nih.gov/33501463Bladder Pain Sensitivity Is a Potential Risk Factor for Irritable Bowel Syndrome.
Arielle E Shlobin, Frank F Tu, Cody R Sain...
https://pubmed.ncbi.nlm.nih.gov/36879177Multimodal hypersensitivity derived from quantitative sensory testing predicts pelvic pain outcome: an observational cohort study.
Matthew J Kmiecik, Frank F Tu, Daniel J Clauw...
https://pubmed.ncbi.nlm.nih.gov/37226937