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Completed

NCT Number: NCT03697720

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

NorthShore University Health System

Evanston, Illinois, 60201, United States

About this study

Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity and cytokine concentrations producing moderate to severe pelvic pain in more than 20% of reproductive-age women. One out of every five of those women in turn will experience chronic pelvic pain (CPP) which may be in part due to cross-organ neural sensitization.

In this study we will establish whether prophylactic and adequate dosages of naproxen are capable of reducing menstrual pain more than *** use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naproxen

Drug

Participants will take naproxen 500mg BID before and for the first 3 days of their period.

Primary outcomes

  1. Change in Menstrual Pain

    Time frame: 6-8 months

    Score on a scale. Specifically, we used a Numeric Rating Scale (NRS)- 0 through 10 scale with 0 being no pain and 10 worst pain imaginable. Results for the worst menstrual pain score on an NRS from the 6-8 mth menstrual pain diary will be compared to baseline pretreatment diary worst pain score.

  2. Change in Participant Bladder Pain Sensitivity From Baseline

    Time frame: 6-8 months

    Score on a scale. Specifically, we used a Visual Analog Scale- 0 through 100 scale with 0 being no pain and 100 worst pain imaginable. Results from the visual analog scale (VAS) of the bladder filling test at the baseline and 6-8 mph followup visit will be compared to determine if naproxen treatment of menstrual pain affected bladder pain. Bladder pain ratings at first urge will be used at the outcome measure.

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2023
First posted
Oct 5, 2018
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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