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A Study to Evaluate the Safety and Initial Efficacy of a Novel Intrauterine Device

NCT01590563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-10-14

Study results available
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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.

Conditions

  • Contraception

Interventions

DEVICE

IUD

Insertion of a spherical IUD, one year follow-up

Sponsors & Collaborators

  • Ocon Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Beata Szoczei, MD · Synexus Hungary Kft.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Hungary

Study Locations

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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 NCT01590563 on ClinicalTrials.gov