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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Reversible Prevention of Pregnancy
• Intervention / Treatment: Device: SCu300A IUB; Device: TCu380A IUD

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Netanya, Israel
    • Women's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 42 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCu300A IUB	Device: SCu300A IUB; Spherical copper contraceptive
Active Comparator: TCu380A	Device: TCu380A IUD; T-shaped copper IUD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perforation rate	Number of subjects with partial or complete perforation through the uterine wall	During device insertion
Device expulsion	Number of subjects with partially or fully ejected devices	12 months
Efficacy in preventing pregnancy	Number of women who become pregnant during the trial period.	12 months
Device malposition	Number of subjects with observed device malposition within the uterine cavity	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menorrhagia and dysmenorrhea rates	Recording of menstrual pain, cramps and irregular bleeding as reported by subjects.	12 months

Collaborators and Investigators

• Sponsor: Ocon Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2014
• Primary Completion (Actual): January 14, 2014
• Study Completion (Actual): January 14, 2014

Study Registration Dates

• First Submitted: December 23, 2013
• First Submitted That Met QC Criteria: January 12, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 4, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: AOS-2000-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No