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 : August 31, 2017
The 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:
Comparison of objective parameters - Pregnancy rate, perforation, expulsion and malposition rates, changes in the endometrial thickness, rate of complications such as infection and anemia and discontinuation rates after 1 year.
Comparison of Subjective parameters - pain during insertion, menstrual characteristics and pain, bleeding in correlation to the bleeding pattern prior to insertion.
Physician opinion: ease of use in insertion and removal. Subject satisfaction.
It is expected that subjects using the copper IUB will demonstrate less safety events, equal effectiveness and equal or improved menstrual bleeding and pain related profiles compared with users of the T shaped copper IUD.
|Condition or disease||Intervention/treatment||Phase|
|Prevention of Pregnancy||Device: SCu300A IUB intrauterine device Device: T380A IUD||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||367 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 :||May 2014|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||August 2017|
|Experimental: SCu300A IUB||
Device: SCu300A IUB intrauterine device
Spherical copper IUD
|Active Comparator: T380A copper IUD||
Device: T380A IUD
T-shaped copper IUD
- Number of uterine perforations during insertion [ Time Frame: At insertion visit ]
- Expulsion and malposition rates [ Time Frame: 12 months ]Number of women who experience partial or full device expulsion or device malposition during the trial period.
- Efficacy in preventing pregnancy [ Time Frame: 12 months ]Recording of the number of women who become pregnant during the trial period.
- Dysmenorrhea and menorrhagia severity [ Time Frame: 12 months ]Recording of menstrual cramping, pain and bleeding irregularities during the trial period as reported by subjects.
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|