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NCT05900336 · ClinicalTrials.gov registry record · Phase 4
Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea
A Phase 4 study, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
NCT05900336 is a Phase 4 study that has completed, run by Mclean Hospital. The registered enrollment target is 70 participants.
The verdict
NCT05900336, a Phase 4 study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG Sodium Naproxen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-03-25 |
| Est. Completion | 2025-08-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05900336
The ClinicalTrials.gov registry entry for NCT05900336 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05900336 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05900336 about?
NCT05900336 is a clinical study titled "Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea". 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, ibu...
What is the current status of trial NCT05900336?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2024-03-25. Estimated completion is 2025-08-01.
What interventions are being tested in trial NCT05900336?
The interventions under investigation include: Placebo (DRUG), Sodium Naproxen (DRUG).
Who is sponsoring clinical trial NCT05900336?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
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