Copper IUD Treatment Observation Study
Public ClinicalTrials.gov record NCT02519231. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center, Double-Blinded, Randomized, Phase IV 6-Month Pilot Study to Compare Bleeding Patterns, Satisfaction and Quality of Life Among New Copper 380A IUD Users Treated With Naproxen Sodium (440mg Twice Daily) Versus Placebo
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02519231
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 34 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2016
- Primary completion
- Oct 31, 2017
- Completion
- Oct 31, 2017
- Last update posted
- Oct 13, 2020
2016 – 2017
United States locations
- U.S. sites
- 5
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | — |
| Harborview Medical Center | Seattle | Washington | 98104 | — |
| UW Neighborhood Clinic Northgate | Seattle | Washington | 98125 | — |
| Hall Health Center | Seattle | Washington | 98195 | — |
| University of Washington Medical Centers | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02519231, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2020 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02519231 live on ClinicalTrials.gov.