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 - 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 - Menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament - Indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCPs) Exclusion Criteria: - Presence of active pelvic or abdominal malignancies (primary or metastatic) - Absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding) - Active genitourinary infection in the last four weeks - Unable to read or comprehend the informed consent in English - Unwilling to complete study procedures - Presence of hypertension or risk for developing hypertension - Unwillingness to take naproxen and/or placebo - Contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or intestinal ulcer or abnormal liver function) - Formal urological diagnosis such as overactive bladder or painful bladder syndrome.


NCT ID:

NCT03697720


Primary Contact:

Principal Investigator
Frank Tu, MD, MPH
NorthShore University HealthSystem

Genevieve Roth
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: January 21, 2020

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