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

StatusCompleted
PhasePhase 4
Started2024-03-25
View on ClinicalTrials.gov ↗

Amendment history

2026-09-23
notable
Results posted: 2026-09-22
2026-08-02
minor
Study Status, Outcome Measures, Outcome Measures (Results) v12
Secondary endpointsdetails revised at 1 of 4 entries
2026-06-29
minor
Study Status, Outcome Measures, Baseline Characteristics, Outcome Measures (Results), Adverse Events v11
Secondary endpoints15 to 4 entries
pain50 pain70 Pressure Pain Sensitivity (PPS) Pressure Pain Tolerance (PPT) Trapezius Pressure Pain Sensitivity (TPPS) Time to Bladder First Sensation Pain at Bladder First Sensation Time to Bladder First Urge Pain at Bladder First Urge Time to Bladder Maximum Tolerance Pain at Bladder Maximum Toler [...]
Primary endpoints3 to 2 entries
Conditioned Pain Modulation (CPM)
2026-05-28
minor
Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v10
Secondary endpoints15 entries, revised
Non-steroidal Anti-inflammatory Drug (NSAID) Cycle Response
Primary endpoints3 entries, revised
Overall Non-steroidal Anti-inflammatory Drug (NSAID) Response
2026-04-20
minor
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v9
Secondary endpoints15 entries, revised
Placebo cycleCycle responseResponse NSAID cycleCycle responseResponse Urinary PGF2α concentrationConcentration Urinary PGE concentrationConcentration Pressure painPain sensitivitySensitivity (PPS) Pressure painPain toleranceTolerance (PPT) Trapezius pressurePressure painPain sensitivitySensitivity (TPPS) Time to bladderBladder firstFirst sensationSensation Pain at bladderBladder firstFirst sensationSensation Time to bladderBladder firstFirst urgeUrge Pain at bladderBladder firstFirst urgeUrge Time to bladderBladder maximumMaximum toleranceTolerance Pain at bladderBladder maximumMaximum toleran [...] [...]
Primary endpoints3 entries, revised
Conditioned painPain modulationModulation (CPM) Overall NSAID responseResponse Urinary naproxenNaproxen concentrationConcentration
Show 8 earlier versions
2026-02-10
minor
Study Status, Oversight, Document Section v8
Re-verified, no change to tracked fields
2025-09-15
notable
Active, Not Recruiting→Completed Study Status, Study Design, Eligibility v7
Trial statusActive, Not Recruiting→Completed
Primary completion dateestimated 2025-07-31→confirmed 2025-08-01
Completion dateestimated 2025-07-31→confirmed 2025-08-01
2025-07-08
minor
Study Status v6
Re-verified, no change to tracked fields
2025-05-25
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-05-31→2025-07-31
Completion date2025-05-31→2025-07-31
Study sitesdetails revised at 1 of 1 site
2025-05-05
minor
Study Status, Oversight, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
2024-03-26
minor
Study Status v3
Start dateestimated 2024-03-08→confirmed 2024-03-25
2024-03-09
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2024-01-01→2024-03-08
Study sites0→1
2023-10-17
minor
Study Status v1
Start date2023-09-01→2024-01-01
2023-06-08
minor
Original filing
53 trials monitored
See 1 trial at risk
Menstrual pain is the most common gynecological complaint and the leading cause of school and work absences in reproductive-age girls and women. One of the primary treatments for menstrual pain is use of nonsteroidal anti-inflammatory drugs (NSAIDs; over-the-counter medications such as naproxen, ibuprofen, or aspirin), although up to 18% of women do not get pain relief from these medications. One reason for this may be due to central sensitization of pain, which is when alterations in the central nervous system change how pain is processed in the brain and experienced. Determining the role of central sensitization in menstrual pain is important because central sensitization is associated with the development of chronic pain. Understanding the relationship between NSAID response and central sensitization is important because it could indicate women who may go on to develop chronic pain later in life. This study would directly address this question. Identifying women at risk for chronic pain would help target new treatments to this vulnerable group to ideally prevent pain from becoming chronic. This is particularly important for women in the military because the severity of menstrual pain is associated with missed work, such that in active-duty military women, less than 4.4% with mild menstrual pain missed work, whereas 20.7% of women with moderate to severe menstrual pain missed work. Addressing the significant impact of menstrual pain for military women will help reducing suffering and potentially decrease the risk of developing future chronic pain problems in this population.
Trial Details
NCT Number NCT05900336
Lead Sponsor Mclean Hospital
Collaborators: United States Department of Defense, Endeavor Health
Conditions Dysmenorrhea, Menstrual Pain, Non-steroidal Anti-inflammatory Drug
Enrollment 70 participants
Start Date 2024-03-25
Primary Completion 2025-08-01 (estimated)
Study Completion 2025-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-22