NCT03697720

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

Completed Phase 4 Results posted Last updated 18 October 2023

What this trial tests

Phase 4 trial testing Naproxen in Dysmenorrhea in 26 participants. Completed in 27 September 2023.

Timeline

9 May 2018

Primary endpoint
23 November 2020

27 September 2023

Quick facts

Lead sponsor	Endeavor Health
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	9 May 2018
Primary completion	23 November 2020
Estimated completion	27 September 2023
Sites	1 location across United States

Drugs / interventions tested

• Naproxen (naproxen) — full drug profile →

Conditions studied

• Dysmenorrhea — all drugs for Dysmenorrhea →
• Pain — all drugs for Pain →

Sponsor

Endeavor Health — full company profile →

Who can join

Adults 18 to 45, female only, with Dysmenorrhea or Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Menstrual Pain Primary · 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.

Group	Value	95% CI
Primary Dysmenorrhea	4.1	± 2.4

Change in Participant Bladder Pain Sensitivity From Baseline Primary · 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.

Group	Value	95% CI
Primary Dysmenorrhea	10.7	± 10.6

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Primary Dysmenorrhea

Serious: 0/26 (0%)

Deaths: 0/26

Other adverse events (1 terms — click to expand)

Reaction	System	Primary Dysmenorrhea
Dyspepsia grade 1	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT03697720 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.