NCT02036177

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

A Prospective, Randomized, Single Blind, Two Arms Controlled Study to Confirm the Safety and Verify Performance of the IUB™ SCu300A Intrauterine Device in Comparison to TCu380 IUD Intra-uterine Contraceptive Device

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Ocon Medical Ltd. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	SCu300A IUB intrauterine device	Spherical copper IUD
DEVICE	T380A IUD	T-shaped copper IUD

Timeline

• Start date: 2014-06-12
• Primary completion: 2017-07-15
• Completion: 2017-07-15
• First posted: 2014-01-14
• Last updated: 2018-07-06

Locations

2 sites across 2 countries: Bulgaria, Romania