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.
Name: SCu300A IUB intrauterine device
Description: Spherical copper IUDType: DeviceSCu300A IUB
Name: T380A IUD
Description: T-shaped copper IUDType: DeviceT380A copper IUD
Description: Perforations, expulsions, mal-position etc
Measure: Safety issues Time: 24 monthsDescription: Recording of menstrual cramping, pain and bleeding irregularities during the trial period
Measure: Patient experience Time: 24 monthsDescription: Ease of use in insertion and removal
Measure: Physician opinion Time: 24 monthsAllocation: Randomized
Parallel Assignment
There is one SNP
Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD 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. --- T380A ---