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Copper IUD Treatment Observation Study

NCT02519231 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-10-14

Study results available
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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.

Conditions

  • Menorrhagia

Interventions

DRUG

Naproxen

Naproxen 440mg 1x pid

DRUG

Placebo

Placebo tablet 440mg 1x pid

Sponsors & Collaborators

  • Cook County Hospital

    collaborator OTHER

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • University of Washington

    lead OTHER

Principal Investigators

  • Emily Godfrey, MD,MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02519231 on ClinicalTrials.gov