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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: Completed Phase 4 study, sponsored by University of Washington.
NCT02519231 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 34 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of bleeding and spotting, spotting only and bleeding only days given as mean. We calculated the mean difference and 95% confidence interval between the two treatment groups and provided the p-value of means.
Interventions
- DRUG Placebo
- DRUG Naproxen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-02 |
| Est. Completion | 2017-11 |
| Phase | Phase 4 |
What the finished NCT02519231 record still lists
NCT02519231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02519231 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02519231's enrollment target sits among peer trials
34 1520th of 2000 higher than 473 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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