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Nonsteroidal Anti-inflammatory Drug

Naproxen Sodium for Menstrual Cramps (MCUP Trial)

Phase 4
Recruiting
Led By Kevin M Hellman, PhD
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Endometriosis Group: Symptomatic for endometriosis and planned surgical excision with confirmed diagnosis of Stage 2, 3, or 4 endometriosis following surgery
Primary Dysmenorrhea Group: Pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament, and average pain rating greater than or equal to 6/10 during menses without NSAIDs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 16 weeks
Awards & highlights

MCUP Trial Summary

This trial will use MRI to investigate different profiles of menstrual pain in women, and how these profiles respond to naproxen.

Who is the study for?
This trial is for women aged 18-45 with severe menstrual pain, small to medium fibroids, or confirmed endometriosis stages 2-4. Healthy controls with minimal pain can also join. Exclusions include those with certain medical conditions, BMI >40, allergies to naproxen, and metallic implants affecting MRI scans.Check my eligibility
What is being tested?
The study tests how Naproxen Sodium affects uterine pain by looking at muscle activity, blood flow and oxygen levels in the uterus using MRI scans. It compares the effects of Naproxen versus a placebo in relieving menstrual cramps.See study design
What are the potential side effects?
Naproxen may cause side effects like stomach issues (e.g., ulcers), heartburn, headaches, dizziness, allergic reactions (rash), kidney problems and increased risk of bleeding.

MCUP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have symptoms of endometriosis and am scheduled for surgery to remove it, with a diagnosis of Stage 2-4 confirmed after surgery.
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I experience severe menstrual pain above a 6/10 without taking pain relievers.
Select...
I have been diagnosed with medium-sized fibroids in my uterus.

MCUP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Calculate phenotype consistency
Calculate response profiles of MRI signals associated with NSAID-resistance
Calculate response profiles of MRI signals for each menstrual pain phenotype
Secondary outcome measures
Anatomical effects
Calculate the relationship between Naproxen absorption and NSAID resistance.
Covariate analysis

MCUP Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Naproxen/Placebo CrossoverActive Control1 Intervention
Participants will be randomized to take either a placebo pill or a single 550 mg naproxen sodium pill. Randomization with a block size only known by the statistician, will be programmed to be allocated out of REDcap. Our clinical research pharmacy will provide naproxen and an identical looking placebo in containers with codes only known to the statistician to provide a double-blinded experimental design. On a subsequent episode of menstrual pain (1-2 months later), participants will receive the opposite treatment and undergo the exact same assessments.
Group II: Placebo/Naproxen CrossoverPlacebo Group1 Intervention
Participants will receive placebo first in this arm.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,672,345 Total Patients Enrolled
16 Trials studying Endometriosis
4,668 Patients Enrolled for Endometriosis
NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,646 Total Patients Enrolled
1 Trials studying Endometriosis
353 Patients Enrolled for Endometriosis
National Institutes of Health (NIH)NIH
2,700 Previous Clinical Trials
7,506,662 Total Patients Enrolled
4 Trials studying Endometriosis
640 Patients Enrolled for Endometriosis

Media Library

Naproxen Sodium (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04145518 — Phase 4
Endometriosis Research Study Groups: Placebo/Naproxen Crossover, Naproxen/Placebo Crossover
Endometriosis Clinical Trial 2023: Naproxen Sodium Highlights & Side Effects. Trial Name: NCT04145518 — Phase 4
Naproxen Sodium (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04145518 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions can be addressed with this form of therapy?

"This particular therapeutic intervention is capable of reducing symptoms related to nasal congestion, seasonal allergic rhinitis, and collagen-based diseases."

Answered by AI

Has this medication been granted approval from the Federal Drug Administration?

"The safety of this particular treatment has been assessed at a level 3 due to the completion of Phase 4 clinical trials, which suggest that it is now approved."

Answered by AI

Has any further research been performed regarding this therapy?

"Currently, there are 10 research projects studying this treatment with 4 of them in the advanced Phase 3 stage. Most studies originate from Philadelphia, Pennsylvania but 18 sites across America are participating."

Answered by AI

How many individuals are being evaluated in this research trial?

"Affirmative. According to information from clinicaltrials.gov, this medical trial is still actively looking for participants; the inaugural post was on October 25th 2019 and it has been updated as recently as May 26th 2022. In total, 214 people are needed at one facility."

Answered by AI

Are octogenarians and beyond being accepted into this experiment?

"As stated in the trial's requirements, only individuals between 18 and 45 years of age can apply for enrollment."

Answered by AI

Are there any available slots for enrolment in this research endeavor?

"Affirmative. Per clinicaltrials.gov, this research initiative is still seeking participants and was initially posted on October 25th 2019. At present, 214 patients are required at a single facility for the investigation to be successful."

Answered by AI

What criteria must be met for potential participants to partake in this clinical trial?

"This clinical trial is seeking 214 volunteers between 18 and 45 years old who have endometrial diseases. Additionally, healthy controls (n=20) must report an average menstrual pain of 2/10 or lower over the past 6 months without taking NSAIDs, with no concurrent pain diagnoses confirmed via questionnaires, medical exams and other criteria established by NIH PROMIS scales, Rome Foundation IBS criteria (Palsson et al., 2016), AUA bladder pain syndrome criteria (Hanno et. al. 2012), and the Complex Medical Symptom Inventory (Williams and Schilling 2009). Furthermore, age-matched pregnancy history will be used"

Answered by AI

Who else is applying?

What site did they apply to?
NorthShore University HealthSystem
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Mechanistic Characterization of Uterine Pain
Kevin Hellman 2019. "Mechanistic Characterization of Uterine Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04145518.
All > Uterine Fibroids > Endometriosis
~15 spots leftby Sep 2024
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