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Trial record 46 of 1664 for:    ( Map: Bulgaria )

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
Sponsor:
Information provided by (Responsible Party):
Ocon Medical Ltd.

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

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



Primary Outcome Measures :
  1. Number of uterine perforations during insertion [ Time Frame: At insertion visit ]
  2. 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.

  3. Efficacy in preventing pregnancy [ Time Frame: 12 months ]
    Recording of the number of women who become pregnant during the trial period.


Secondary Outcome Measures :
  1. Dysmenorrhea and menorrhagia severity [ Time Frame: 12 months ]
    Recording of menstrual cramping, pain and bleeding irregularities during the trial period as reported by subjects.



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Ages Eligible for Study:   25 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Adult females aged 25-42
  • 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%
  • 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
  • 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)
  • 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

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
Bulgaria
Sofia, Bulgaria
Romania
Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie
Bucharest, Romania
Sponsors and Collaborators
Ocon Medical Ltd.

Responsible Party: Ocon Medical Ltd.
ClinicalTrials.gov Identifier: NCT02036177     History of Changes
Other Study ID Numbers: AOS-2000-04
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Copper
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs