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

Not Applicable

Withdrawn

• Conditions: Reversible Prevention of Pregnancy
• Interventions: Device: SCu300A IUB; Device: TCu380A IUD

• Registration Number: NCT02036203
• Lead Sponsor: Ocon Medical Ltd.

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 available

Study Timeline

• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2014-01-12
• Study Start: 2014-01-14
• Primary Completion: 2014-01-14
• Study Completion: 2014-01-14
• Study First Posted: 2014-01-14
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCu300A IUB	SCu300A IUB	-
TCu380A	TCu380A IUD	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Women's Health Center; 🇮🇱 Netanya, Israel