Phase 4
N=26
Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
Dysmenorrhea · Pain
Bottom Line
View on ClinicalTrials.gov: NCT03697720 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Change in Menstrual Pain — 4.1 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Naproxen (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Endeavor Health
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Menstrual Pain |
4.1 | <0.0001 sig |
| PRIMARY Change in Participant Bladder Pain Sensitivity From Baseline |
10.7 | .119 |
Summary
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.
Eligibility 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 bladder pain syndrome.
Data sourced from ClinicalTrials.gov (NCT03697720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.