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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
366
Spherical copper IUD
T-shaped copper IUD
Unnamed facility
Sofia, Bulgaria
Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie
Bucharest, Romania
Pregnancy rate
Time frame: 24 months
Safety issues
Perforations, expulsions, mal-position etc
Time frame: 24 months
Discontinuation rate
Time frame: 24 months
Patient experience
Recording of menstrual cramping, pain and bleeding irregularities during the trial period
Time frame: 24 months
Physician opinion
Ease of use in insertion and removal
Time frame: 24 months
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