Evanston, Illinois 60201


Purpose:

The goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea will improve pain report from baseline. In addition, we will determine whether cross-organ influences from the uterus on bladder pain sensitivity change from baseline after reduced menstrual pain experience over six months. Finally, a battery of quantitative sensory tests and EEG measures of sensory sensitivity will be used to evaluate mechanisms associated with improvements in menstrual and bladder pain.


Criteria:

Inclusion Criteria: Reproductive-age women (age 18-45) with dysmenorrhea will be recruited. Cases will have: a) average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least one day during menses or during withdrawal uterine bleeding from cyclic OCs without painkillers, b) menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament, and c) indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCPs). Participants who endorse bladder symptoms (subclinical urgency, frequency, bladder pain) on the phone screen or bladder symptoms will represent at least 50% of enrolled participants); those who do not endorse bladder symptoms may be determined ineligible. They must not have a formal urological diagnosis such as overactive bladder or painful bladder syndrome. Exclusion Criteria: Includes: a) presence of active pelvic or abdominal malignancies (primary or metastatic), b) absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding), c) active genitourinary infection in the last four weeks, d) unable to read or comprehend the informed consent in English, e) unwilling to complete study procedures, and f) presence of hypertension or risk for developing hypertension, g) unwillingness to take naproxen and/or placebo, h) or contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or intestinal ulcer or abnormal liver function). Participants with a history of epilepsy will not complete the visual unpleasantness task.


NCT ID:

NCT03697720


Primary Contact:

Principal Investigator
Frank Tu, MD, MPH
NorthShore University HealthSystem

Nicole Steiner
Phone: 847-570-2622
Email: pelvicpainresearch@northshore.org


Backup Contact:

N/A


Location Contact:

Evanston, Illinois 60201
United States

Nicole Steiner, BS
Phone: 847-570-2622
Email: pelvicpainresearch@northshore.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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