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Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD

NCT02036177 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2018-07-06

No results posted yet for this study

Summary

The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.

The Primary Endpoints for comparison are based on the objective and subjective parameters.

The objective parameters are pregnancy rate, perforation, expulsion and mal -position rates, changes in the endometrial thickness, rate of complications such as infection and anemia and discontinuation rates after 2 years.

The subjective parameters including Quality of Life (QoL) are: pain during insertion, menstrual characteristics and pain, bleeding in correlation to the bleeding pattern prior to insertion.

The Secondary Endpoints are physician opinion (ease of use in insertion and removal) and subject satisfaction.

Conditions

  • To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB

Interventions

DEVICE

SCu300A IUB intrauterine device

Spherical copper IUD

DEVICE

T380A IUD

T-shaped copper IUD

Sponsors & Collaborators

  • Ocon Medical Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-06-12
Primary Completion
2017-07-15
Completion
2017-07-15

Countries

  • Bulgaria
  • Romania

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 NCT02036177 on ClinicalTrials.gov