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Trial record 2 of 3 for:    ocon medical

A Study on the Safety and Efficacy of the SCu300A IUB Compared to the TCu380 Copper IUD

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Ocon Medical Ltd.
Sponsor:
Information provided by (Responsible Party):
Ocon Medical Ltd.
ClinicalTrials.gov Identifier:
NCT02036203
First received: December 23, 2013
Last updated: January 12, 2014
Last verified: January 2014
  Purpose

This study aims to evaluate the safety and efficacy of the IUB SCu300A spherical copper IUD compared to the standard T shaped copper IUD, the TCu380.

Participants will be followed for one year and quality of life measurements will be measured during this period as well.


Condition Intervention Phase
Reversible Prevention of Pregnancy
Device: SCu300A IUB
Device: TCu380A IUD
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Single Blind, Two Arms Controlled Study of the Safety and Efficacy of the SCu300A IUB™ Spherical Copper Intrauterine Ball in Comparison to TCu 380 IUD Intra-uterine Contraceptive Device

Further study details as provided by Ocon Medical Ltd.:

Primary Outcome Measures:
  • Perforation rate [ Time Frame: During device insertion ] [ Designated as safety issue: Yes ]
    Number of subjects with partial or complete perforation through the uterine wall

  • Device expulsion [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Number of subjects with partially or fully ejected devices

  • Efficacy in preventing pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Number of women who become pregnant during the trial period.

  • Device malposition [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Number of subjects with observed device malposition within the uterine cavity


Secondary Outcome Measures:
  • Menorrhagia and dysmenorrhea rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Recording of menstrual pain, cramps and irregular bleeding as reported by subjects.


Estimated Enrollment: 60
Study Start Date: April 2014
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCu300A IUB Device: SCu300A IUB
Spherical copper contraceptive
Active Comparator: TCu380A Device: TCu380A IUD
T-shaped copper IUD

  Eligibility

Ages Eligible for Study:   25 Years to 42 Years
Genders 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(major)

  • 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 post abortal endometritis in the past 3 month
  • Mucopurulent cervicitis
  • Endometrial thickness more than 12 mm on insertion date
  • Known 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036203

Locations
Israel
Women's Health Center Not yet recruiting
Netanya, Israel
Contact       info@oconmed.com   
Principal Investigator: Yael Barkan, MD         
Sponsors and Collaborators
Ocon Medical Ltd.
  More Information

No publications provided

Responsible Party: Ocon Medical Ltd.
ClinicalTrials.gov Identifier: NCT02036203     History of Changes
Other Study ID Numbers: AOS-2000-05
Study First Received: December 23, 2013
Last Updated: January 12, 2014
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on November 20, 2014