SCu300A IUB intrauterine device
DeviceSpherical copper IUD
NCT Number: NCT02036177
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.
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Notify Me18 year–45 year
Female
Interventional
Phase 4
Sofia, Bulgaria
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Spherical copper IUD
T-shaped copper IUD
Time frame: 24 months
Time frame: 24 months
Perforations, expulsions, mal-position etc
Time frame: 24 months
Time frame: 24 months
Recording of menstrual cramping, pain and bleeding irregularities during the trial period
Time frame: 24 months
Ease of use in insertion and removal
Ocon Medical Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.