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

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

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.

Study Overview

• Status: Completed
• Conditions: To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
• Intervention / Treatment: Device: SCu300A IUB intrauterine device; Device: T380A IUD

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
• Romania
  • Bucharest, Romania
    • Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

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 intrauterine device; Spherical copper IUD
Active Comparator: T380A copper IUD	Device: T380A IUD; T-shaped copper IUD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate		24 months
Safety issues	Perforations, expulsions, mal-position etc	24 months
Discontinuation rate		24 months
Patient experience	Recording of menstrual cramping, pain and bleeding irregularities during the trial period	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician opinion	Ease of use in insertion and removal	24 months

Collaborators and Investigators

• Sponsor: Ocon Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2014
• Primary Completion (Actual): July 15, 2017
• Study Completion (Actual): July 15, 2017

Study Registration Dates

• First Submitted: December 19, 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

• Keywords: IUB
• Other Study ID Numbers: AOS-C2000

Drug and device information, study documents

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