To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB Clinical Trial
Official title:
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
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.
n/a