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

Sponsor

NorthShore University HealthSystem (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03697720

Collaborator

(none)

Enrollment

Location

Arm

47.7

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysmenorrhea Pain	Drug: Naproxen	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 9, 2018

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Primary Dysmenorrhea We will look at the effects of naproxen 500mg use on pain starting just before and during menses.	Drug: Naproxen Participants will take naproxen 500mg BID before and for the first 3 days of their period.

Arm

Intervention/Treatment

Experimental: Primary Dysmenorrhea

We will look at the effects of naproxen 500mg use on pain starting just before and during menses.

Drug: Naproxen

Participants will take naproxen 500mg BID before and for the first 3 days of their period.

Outcome Measures

Primary Outcome Measures

Menstrual Pain [6-8 months]
Daily Diary data on menstrual pain-is it improved with the use of naproxen?
Bladder Pain [6-8 months]
Experimental Bladder Pain sensitivity using a naturalistic paradigm-is it improved when menstrual pain is treated with naproxen?

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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 painful bladder syndrome.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NorthShore University Health System	Evanston	Illinois	United States	60201

Sponsors and Collaborators

NorthShore University HealthSystem

Investigators

Principal Investigator: Frank Tu, MD, MPH, NorthShore University HealthSystem

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Frank Tu, Division Director MIS/Clinical Associate Professor, NorthShore University HealthSystem

ClinicalTrials.gov Identifier:

NCT03697720

Other Study ID Numbers:

EH18-128

First Posted:

Oct 5, 2018

Last Update Posted:

Feb 4, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Frank Tu, Division Director MIS/Clinical Associate Professor, NorthShore University HealthSystem

cross-organ sensitivity

bladder pain

NSAID

visceral pain

Additional relevant MeSH terms:

Dysmenorrhea

Naproxen

Study Results

No Results Posted as of Feb 4, 2022