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

Phase 4

Completed

• Conditions: To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
• Interventions: Device: SCu300A IUB intrauterine device; Device: T380A IUD

• Registration Number: NCT02036177
• Lead Sponsor: Ocon Medical Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2014-01-12
• Study First Posted: 2014-01-14
• Study Start: 2014-06-12
• Primary Completion: 2017-07-15
• Study Completion: 2017-07-15
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 366

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCu300A IUB	SCu300A IUB intrauterine device	-
T380A copper IUD	T380A IUD	-

Primary Outcome Measures

Name	Time	Method
Safety issues	24 months	Perforations, expulsions, mal-position etc
Pregnancy rate	24 months
Patient experience	24 months	Recording of menstrual cramping, pain and bleeding irregularities during the trial period
Discontinuation rate	24 months

Secondary Outcome Measures

Name	Time	Method
Physician opinion	24 months	Ease of use in insertion and removal

Trial Locations

Locations (1)

Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie; 🇷🇴 Bucharest, Romania