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NCT02519231 · ClinicalTrials.gov registry record · Phase 4
Copper IUD Treatment Observation Study
A Phase 4 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
NCT02519231 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 34 participants.
The verdict
NCT02519231, a Phase 4 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
Study Summary
Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
Interventions
- DRUG Placebo
- DRUG Naproxen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-02 |
| Est. Completion | 2017-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02519231
The ClinicalTrials.gov registry entry for NCT02519231 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02519231 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02519231 about?
NCT02519231 is a clinical study titled "Copper IUD Treatment Observation Study". Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with...
What is the current status of trial NCT02519231?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2016-02. Estimated completion is 2017-11.
What interventions are being tested in trial NCT02519231?
The interventions under investigation include: Placebo (DRUG), Naproxen (DRUG).
Who is sponsoring clinical trial NCT02519231?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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