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Non-Steroidal Anti-Inflammatory Drug

Sodium Naproxen first for Menstrual Pain

Phase 4

Recruiting

Led By Laura Payne, PhD

Research Sponsored by Mclean Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)

Awards & highlights

Study Summary

This trial aims to understand why some women do not get relief from over-the-counter medications like ibuprofen for menstrual pain. The study will investigate how changes in the nervous system may affect pain processing and

Who is the study for?

This trial is for women aged 18-50 who experience severe menstrual pain, rating it at least a 6 out of 10. They should have had regular menstrual cycles over the past year and be able to use a smartphone and email. Participants must understand English and consent to the study.Check my eligibility

What is being tested?

The study tests if Sodium Naproxen, an NSAID, can relieve severe menstrual cramps compared to a placebo. It also examines how the central nervous system's response might influence chronic pain development in these women.See study design

What are the potential side effects?

NSAIDs like Sodium Naproxen may cause digestive issues (like stomach pain or heartburn), headaches, dizziness, allergic reactions, or increase bleeding risk. Long-term use can sometimes lead to kidney problems or high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Conditioned pain modulation (CPM)

Overall NSAID response

Urinary naproxen concentration

Secondary outcome measures

NSAID cycle response

Pain at bladder first sensation

Pain at bladder first urge

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sodium Naproxen firstExperimental Treatment2 Interventions

Participants take the dose of sodium naproxen during the first menstrual cycle and take the placebo during the second menstrual cycle.

Group II: Placebo firstExperimental Treatment2 Interventions

Participants take the dose of placebo during the first menstrual cycle and take the sodium naproxen during the second menstrual cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor

213 Previous Clinical Trials

21,624 Total Patients Enrolled

United States Department of DefenseFED

865 Previous Clinical Trials

327,629 Total Patients Enrolled

NorthShore University HealthSystemOTHER

132 Previous Clinical Trials

737,588 Total Patients Enrolled

Frequently Asked Questions

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

Are there ongoing efforts to enroll participants in this medical study at the moment?

"As per information available on clinicaltrials.gov, this research is presently in the recruitment phase. The trial was initially listed on March 8th, 2024 and last modified on March 9th, 2024."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical trial?

"Indeed, the details on clinicaltrials.gov highlight that this particular clinical trial is actively pursuing eligible candidates. The trial was first shared on March 8th, 2024 and most recently revised on March 9th, 2024. A total of 70 participants will be enrolled at a single designated site."

Answered by AI

What are the potential risks of Sodium Naproxen when used by individuals for the first time?

"Rated as a 3 on the scale, our evaluation at Power deems Sodium Naproxen's safety to be high due to its Phase 4 trial status, marking it as an approved treatment."

Answered by AI

Is the clinical trial open to participants younger than 30 years old?

"Individuals aged 50 years are the target population for this trial, with criteria specifying that participants must not be younger or older than this age range."

Answered by AI

Which specific individuals meet the eligibility criteria to participate in this research endeavor?

"This trial seeks to enroll 70 participants experiencing menstrual discomfort aged between 18 and 50. Specifically, eligible candidates must be female, report a minimum pain level of 6 out of 10 for all menstrual cycles within the last half-year, have maintained regular monthly periods over the past year (minimum of nine in the previous twelve months), state an average cycle length ranging from 22 to 35 days, possess both smartphone and email access as well as readiness to receive text messages, demonstrate proficiency in English comprehension, and exhibit capability along with willingness to furnish written informed consent."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea

Laura Payne 2024. "Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05900336.