Endeavor Health
Evanston, Illinois, 60201, United States
Location status: Recruiting
Location contact
Frank Tu, MD, MPH
SUB_INVESTIGATOR
Kevin Hellman, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06861920
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
Interested in participating?
Request Info18 year–35 year
Female
Interventional
Phase 4
Evanston, Illinois, 60201, United States
Location status: Recruiting
Frank Tu, MD, MPH
SUB_INVESTIGATOR
Kevin Hellman, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Aleve
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.
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.
Other names: Tylenol
Time frame: From enrollment to end of treatment at 1-year
"Non-menstrual pelvic pain (NMPP) will be assessed as the average of bladder, bowel, and non-menstrual pelvic pain ratings (0-10 scale) on non-bleeding days, excluding the two days before menstruation. Daily menstrual pain will be recorded during Menses (0-10 scale). The primary outcome is the reduction in NMPP at cycles 3,6,9, and 12, modeled using structural equation modeling to examine mediation by menstrual pain response to NSAIDs, accounting for endometrial inflammation (effluent cytokine levels). The mediation effect (M1) will be quantified using standardized path coefficients and indirect effects with bootstrapped 95% confidence intervals to determine the proportion of the NSAID effect on NMPP reduction. This outcome ranges from -1 to +1, with positive values indicating a worsening and negative values indicating a better mediation outcome.
Time frame: From enrollment to end of treatment at 1-year
In a structural equation model, VVC (bladder pain at first urge on 0-100 visual analog scale) and Multimodal Hypersensitivity) (reflecting widespread increased experimental sensitivity during the visual task, audio task, pressure pain tests, cold pressor, and conditioned pain modulation) will be constructed as a latent variable) mediation of the effect of NSAIDS on reductions in NMPP using a structural equation model. The mediation effect (V1) will be quantified using standardized path coefficients and indirect effects with bootstrapped 95% confidence intervals to determine the proportion of the VVC effect on NMPP. This outcome ranges from -1 to +1, with positive values indicating an worsening outcome and negative values indicating a better outcome.
Time frame: From enrollment to end of treatment at 1-year
Non-menstrual pelvic pain (NMPP) will be measured as the average of bladder, bowel, and non-menstrual pelvic pain ratings (0-10 scale) on non-bleeding days, excluding the two days before menstruation. Change in NMPP over time will be modeled using Structural Equation Modeling, adjusting for uterine inflammation (effluent prostaglandin concentration), sex hormones (estradiol, progesterone), and psychosocial factors (anxiety, depression, stress, sleep). The change in NMPP will be reported on a -10 to +10 scale, where -10 indicates improvement and +10 indicates worsening.
Time frame: From enrollment to end of treatment at 1-year
The impact of NSAIDs on non-menstrual pelvic pain (NMPP) will be assessed by comparing participants using NSAIDs to those on placebo. Treatment effects will be measured as the difference in NMPP scores between the NSAID and placebo groups over time (Baseline, 4, 8, and 12 months) using electronic daily diaries. NMPP will be recorded on a 0-10 scale, where 0 indicates no pain (better outcome) and 10 indicates severe pain (worse outcome)
Time frame: From enrollment to end of treatment at 1-year
The impact of NSAIDs on chronic pelvic pain (CPP) will be assessed by comparing participants using NSAIDs to those on placebo. Treatment effects will be measured by the proportion of participants meeting diagnostic criteria for CPP based on electronic daily diaries at Baseline, 4, 8, and 12 months. CPP status will be reported as a percentage, where 0% indicates no CPP (best outcome) and 100% indicates all participants meeting CPP criteria (worst outcome).
Contact information is provided by the study sponsor or research team.
Endeavor Health
Other
Targeting Interindividual Variability in NSAID Responses to Mitigate Chronic Pelvic Pain Risk in Dysmenorrhea (NSAID HEAL)
Acronym: NSAIDHEAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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