Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
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|ClinicalTrials.gov Identifier: NCT02036177|
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : July 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB||Device: SCu300A IUB intrauterine device Device: T380A IUD||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||366 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||June 12, 2014|
|Actual Primary Completion Date :||July 15, 2017|
|Actual Study Completion Date :||July 15, 2017|
|Experimental: SCu300A IUB||
Device: SCu300A IUB intrauterine device
Spherical copper IUD
|Active Comparator: T380A copper IUD||
Device: T380A IUD
T-shaped copper IUD
- Pregnancy rate [ Time Frame: 24 months ]
- Safety issues [ Time Frame: 24 months ]Perforations, expulsions, mal-position etc
- Discontinuation rate [ Time Frame: 24 months ]
- Patient experience [ Time Frame: 24 months ]Recording of menstrual cramping, pain and bleeding irregularities during the trial period
- Physician opinion [ Time Frame: 24 months ]Ease of use in insertion and removal
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036177
|Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie|