NCT03697720

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Dysmenorrhea
• Pain

Interventions

Type	Name	Description
DRUG	Naproxen	Participants will take naproxen 500mg BID before and for the first 3 days of their period.

Timeline

• Start date: 2018-05-09
• Primary completion: 2020-11-23
• Completion: 2023-09-27
• First posted: 2018-10-05
• Last updated: 2023-10-18
• Results posted: 2023-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study