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
Name: T380A IUD
Description: Perforations, expulsions, mal-position etcMeasure: Safety issues Time: 24 months
Description: Recording of menstrual cramping, pain and bleeding irregularities during the trial periodMeasure: Patient experience Time: 24 months
Description: Ease of use in insertion and removalMeasure: Physician opinion Time: 24 months
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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 ---