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Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02036177
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ocon Medical Ltd.

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: SCu300A IUB Device: SCu300A IUB intrauterine device
Spherical copper IUD
Active Comparator: T380A copper IUD Device: T380A IUD
T-shaped copper IUD


Outcome Measures
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Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 24 months ]
  2. Safety issues [ Time Frame: 24 months ]
    Perforations, expulsions, mal-position etc

  3. Discontinuation rate [ Time Frame: 24 months ]
  4. Patient experience [ Time Frame: 24 months ]
    Recording of menstrual cramping, pain and bleeding irregularities during the trial period


Secondary Outcome Measures :
  1. Physician opinion [ Time Frame: 24 months ]
    Ease of use in insertion and removal


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Adult females aged 18-45
  • Free and willing to fully comply with treatment process
  • Healthy women seeking LARC
  • Married or in a steady relationship (at least 1 year)
  • Blood hemoglobin >11.5gr/dL
  • Signed informed consent form
  • If took COCP at least had one cycle after use of OC

Exclusion criteria:

  • Use IUB/IUD as an emergency contraception
  • A previously placed IUD that has not been removed
  • Pregnancy or suspicion of pregnancy
  • Immediately post-abortion or post-partum - unless had at least one free cycle
  • Use of other contraception method (condom for either male or female, oral contraceptives, diaphragms, spermicides, hormonal patches, injections or ring, cervical cap)
  • History of pelvic inflammatory disease, recent or remote.
  • Postpartum endometritis or postabortal endometritis in the past 3 month
  • Mucupurulent cervicitis
  • Endometrial thickness more than 12 mm on insertion date
  • Known anemia (except thalassemia, sickle cell, chronic anemia)
  • Severe Mennorrhagia or severe Dysmenorrhea
  • History of previous IUD complications
  • Dysfunctional uterine bleeding
  • Undiagnosed uterine bleeding
  • Malignancy or suspected malignant disease of female inner or outer genitalia
  • Distortions of the uterine cavity by uterine fibroids or known anatomical abnormalities
  • Known intolerance or allergy to nitinol or copper and/or copper IUDs - Wilson's disease.
  • Medication that may interfere with the subject's ability to complete the protocol
  • Use of injectable contraception in the previous year
  • Any other significant disease or condition that could interfere with the subject's ability to complete the protocol
  • A history of alcohol or drug abuse
  • Known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
  • Pregnancy or pregnancy planned during the year
  • Enrollment (less than 30 days after completing another study) in or planned to be enrolled in another study
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Bulgaria
Sofia, Bulgaria
Romania
Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie
Bucharest, Romania
Sponsors and Collaborators
Ocon Medical Ltd.
More Information
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Responsible Party: Ocon Medical Ltd.
ClinicalTrials.gov Identifier: NCT02036177    
Other Study ID Numbers: AOS-C2000
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ocon Medical Ltd.:
IUB