Overview

Copper IUD Treatment Observation Study

Status:
Completed
Trial end date:
2017-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Washington
Collaborators:
Cook County Hospital
Teva Pharmaceuticals USA
Treatments:
Copper
Naproxen