CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
IUBdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01973777
NCT01973777N/ACompleted
CompareCT.gov

A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A Spherical Copper Intrauterine Contraceptive Device.

Wiebe, Ellen, M.D.·interventional·Posted Nov 1, 2013·Updated Sep 6, 2019

In Brief

A clinical study evaluating IUB for Contraception. Completed, enrolled 51 participants across 1 site.

Detailed Summary

The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial pilot of 15 women, there were no complications during the 12 months. This observational pilot study of 50 women will determine that the early expulsion rate is not greater than 10% and that there is patient and physician acceptance, so that we can plan a larger randomized controlled trial for efficacy and safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 1, 2013
Enrollment StartDec 1, 2013
Primary CompletionMay 1, 2015
Study CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.7 years ago

Interventions

IUBdevice

intrauterine contraceptive device