Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-16 @ 5:58 AM
Study NCT ID:
NCT03697720
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2018-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
Sponsor:
Endeavor Health
Organization:
Study Overview
Official Title:
Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
In this study we will establish whether prophylactic and adequate dosages of naproxen are capable of reducing menstrual pain more than \*\*\* use.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: