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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2023-09-27

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dysmenorrhea Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Primary Dysmenorrhea

We will look at the effects of naproxen 500mg use on pain starting just before and during menses.

Group Type EXPERIMENTAL

Naproxen

Intervention Type DRUG

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

Interventions

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Naproxen

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No