NorthShore University Health System
Evanston, Illinois, 60201, United States
NCT Number: NCT03697720
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.
Looking for future studies?
Notify Me18 year–45 year
Female
Interventional
Phase 4
Evanston, Illinois, 60201, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Time frame: 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.
Time frame: 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.
Endeavor Health
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06842329
Agnosia, Distraction Methods
Samsun, Turkey (Türkiye)
View Trial DetailsNCT07633990
Dysmenorrhea, Dyssomnias
Siirt, Baykan, Turkey (Türkiye)
View Trial DetailsNCT07481552
Dysmenorrhea, Menstruation Disturbances
Çanakkale, Turkey (Türkiye)
View Trial DetailsNCT06896851
Dysmenorrhea, Menstruation Disturbances
Istanbul, Ataşehir, Turkey (Türkiye)
View Trial Details