Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain

EH18-128

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.

2018-05-09

2020-11-23

2023-09-27

Completed

Early phase I

26

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 bladder pain syndrome.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}

2023-10-18