A Study on the Safety and Efficacy of the SCu300A IUB Com... | NCT02036203

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

NCT02036203

Sponsor

Ocon Medical Ltd.

Status

Withdrawn

Last Update Posted

Jul 6, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Reversible Prevention of Pregnancy

Interventions

SCu300A IUB
TCu380A IUD

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was withdrawn prior to patients enrolment due to sponsor's decision

Expanded Access Info

Start Date

Jan 14, 2014Actual

Primary Completion Date

Jan 14, 2014Actual

Completion Date

Jan 14, 2014Actual

First Submitted Date

Dec 23, 2013

First Submission Date that Met QC Criteria

Jan 12, 2014

First Posted Date

Jan 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2018

Last Update Posted Date

Jul 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
SCu300A IUB	Experimental		Device: SCu300A IUB
TCu380A	Active Comparator		Device: TCu380A IUD

Name	Type	Description	Arm Group Labels	Other Names
SCu300A IUB	Device	Spherical copper contraceptive	SCu300A IUB
TCu380A IUD

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided