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NCT04145518 · ClinicalTrials.gov registry record · Phase 4
Mechanistic Characterization of Uterine Pain
A Phase 4 study, sponsored by Endeavor Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 183
- Enrollment target
NCT04145518 is a Phase 4 study that has completed, run by Endeavor Health. The registered enrollment target is 183 participants.
The verdict
NCT04145518, a Phase 4 study, has completed, sponsored by Endeavor Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 183 participants
- Enrollment target
Study Summary
There are limited treatment options for management of dysmenorrhea, and the physiological processes they affect are not completely understood. For example, NSAIDs are effective in reducing menstrual pain in some women by inhibition of prostaglandin synthesis, but whether those effects are mediated by affecting contractility, perfusion, or hypoxemia is unknown. Understanding how these drugs relieve menstrual pain (and why they fail) would be of substantial clinical significance. Given the foregoing, Two Specific Aims are proposed: Aim #1: Characterize menstrual pain phenotypes associated with impairments in myometrial activity, perfusion, and/or oxygenation. Continuous MRI scans of the uterus will be performed with simultaneous measurement of self-reported pain in healthy women and those experiencing menstrual pain. The investigators will include cohorts of women with imaging diagnosed leiomyoma and surgically-confirmed endometriosis to evaluate the contribution of structurally identifiable factors. Based on preliminary data, the investigators anticipate finding four phenotypes with menstrual pain related to: 1) myometrial activity, 2) inadequate perfusion and/or oxygenation, 3) a combination of phenotypes 1 \& 2, and 4) a non-uterine source. Aim #2: Evaluate the effects of naproxen on myometrial activity, perfusion, and/or oxygenation with respect to pain relief. In women with primary dysmenorrhea, the investigators will acquire pelvic MRI scans and evaluate self-reported menstrual cramping pain before and after administration of randomized naproxen or placebo. Naproxen could principally affect one or more potential sources of uterine pain such as myometrial activity, perfusion, and/or oxygenation. The investigators will corroborate preliminary data findings, which suggest menstrual phenotypes with myometrial activity will be more likely to respond. Conversely, Aim 2 will also elucidate the mechanisms responsible for inadequate pain relief from naproxen. Bioavai
Interventions
- DRUG Naproxen Sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2019-10-25 |
| Est. Completion | 2025-07-23 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04145518
The ClinicalTrials.gov registry entry for NCT04145518 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 183 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Naproxen Sodium is the first listed.
NCT04145518 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04145518 about?
NCT04145518 is a clinical study titled "Mechanistic Characterization of Uterine Pain". There are limited treatment options for management of dysmenorrhea, and the physiological processes they affect are not completely understood. For example, NSAIDs are effective in reducing menstrual pain in some women by inhibition of prostaglandin synthesis, but whether those effects are mediated b...
What is the current status of trial NCT04145518?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 183 participants. The study started on 2019-10-25. Estimated completion is 2025-07-23.
What interventions are being tested in trial NCT04145518?
The interventions under investigation include: Naproxen Sodium (DRUG).
Who is sponsoring clinical trial NCT04145518?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
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