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

NCT03697720 | Completed Phase 4 Results FDA Drug

• 1 other identifier: EH18-128
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea; Pain

Keywords

cross-organ sensitivity; bladder pain; NSAID; visceral pain

Outcome Measures

Primary Outcomes (2)

• Change in Menstrual Pain

  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.

  6-8 months

• Change in Participant Bladder Pain Sensitivity From Baseline

  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.

  6-8 months

Study Arms (1)

Primary Dysmenorrhea

EXPERIMENTAL

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

Drug: Naproxen

Interventions

Naproxen DRUG

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

Primary Dysmenorrhea

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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 bladder pain syndrome.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Related Publications (3)

• Chan WY, Dawood MY, Fuchs F. Prostaglandins in primary dysmenorrhea. Comparison of prophylactic and nonprophylactic treatment with ibuprofen and use of oral contraceptives. Am J Med. 1981 Mar;70(3):535-41. doi: 10.1016/0002-9343(81)90576-3.

  PMID: 7011011 BACKGROUND

• Oladosu FA, Tu FF, Hellman KM. Nonsteroidal antiinflammatory drug resistance in dysmenorrhea: epidemiology, causes, and treatment. Am J Obstet Gynecol. 2018 Apr;218(4):390-400. doi: 10.1016/j.ajog.2017.08.108. Epub 2017 Sep 6.

  PMID: 28888592 BACKGROUND

• Tu FF, Datta A, Atashroo D, Senapati S, Roth G, Clauw DJ, Hellman KM. Clinical profile of comorbid dysmenorrhea and bladder sensitivity: a cross-sectional analysis. Am J Obstet Gynecol. 2020 Jun;222(6):594.e1-594.e11. doi: 10.1016/j.ajog.2019.12.010. Epub 2019 Dec 20.

  PMID: 31870730 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Pain; Visceral Pain

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Neurologic Manifestations; Signs and Symptoms; Nociceptive Pain

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

There was some loss to follow-up. We did not systematically query for adverse events.

Results Point of Contact

• Title: Kevin Hellman, Research Associate Professor
• Organization: NorthShore University HealthSystem

khellman@northshore.org

847-570-2622

Study Officials

• Frank Tu, MD, MPH

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director MIS/Clinical Professor

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 5, 2018
• Study Start: May 9, 2018
• Primary Completion: November 23, 2020
• Study Completion: September 27, 2023
• Last Updated: October 18, 2023
• Results First Posted: October 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)