Trial record 2 of 4 for:    ocon medical

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ocon Medical Ltd.
ClinicalTrials.gov Identifier:
NCT02036177
First received: December 19, 2013
Last updated: March 11, 2015
Last verified: March 2015
  Purpose

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 Intervention Phase
Prevention of Pregnancy
Device: SCu300A IUB intrauterine device
Device: T380A 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 to Confirm the Safety and Verify Performance of the IUB™ SCu300A Intrauterine Device in Comparison to TCu380 IUD Intra-uterine Contraceptive Device

Further study details as provided by Ocon Medical Ltd.:

Primary Outcome Measures:
  • Number of uterine perforations during insertion [ Time Frame: At insertion visit ] [ Designated as safety issue: Yes ]
  • Expulsion and malposition rates [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Recording of the number of women who become pregnant during the trial period.


Secondary Outcome Measures:
  • Dysmenorrhea and menorrhagia severity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Recording of menstrual cramping, pain and bleeding irregularities during the trial period as reported by subjects.


Enrollment: 363
Study Start Date: May 2014
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCu300A IUB Device: SCu300A IUB intrauterine device
Spherical copper IUD
Active Comparator: T380A copper IUD Device: T380A 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:

  • 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
  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: NCT02036177

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

No publications provided

Responsible Party: Ocon Medical Ltd.
ClinicalTrials.gov Identifier: NCT02036177     History of Changes
Other Study ID Numbers: AOS-2000-04
Study First Received: December 19, 2013
Last Updated: March 11, 2015
Health Authority: Romania: Ministry of Health
Bulgaria: Ministry of Health

ClinicalTrials.gov processed this record on July 28, 2015