CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
IUDdevice
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/NCT01590563
NCT01590563N/ACompleted
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A Study to Evaluate the Safety and Initial Efficacy of a Spherical Copper Intrauterine Contraceptive Device the IUB(tm)

Ocon Medical Ltd.·interventional·Posted May 3, 2012·Updated Oct 14, 2020

In Brief

A clinical study evaluating IUD for Contraception. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Current intrauterine devices (IUD) pose such risks as uterine perforation during insertion, malposition and expulsion. The investigated device, the IUB(tm) SCu300A is an IUD which is inserted in a similar fashion into the uterus and takes a three dimensional spherical shape while curving away from the fundus. Apart for an anticipated reduction in the rate of stated complications, its smaller size and mallable characteristics are also expected to improve user experience. The clinical trial is intended to evaluate the safety and initial efficacy of this novel device.

Study Details

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

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 3, 2012
Enrollment StartApr 1, 2012
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.2 years ago

Interventions

IUDdevice

Insertion of a spherical IUD, one year follow-up