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

NCT ID: NCT02036203

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-14
• Study Completion Date: 2014-01-14

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.

Conditions

Reversible Prevention of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

SCu300A IUB

Group Type: EXPERIMENTAL

SCu300A IUB

Intervention Type: DEVICE

Spherical copper contraceptive

TCu380A

Group Type: ACTIVE_COMPARATOR

TCu380A IUD

Intervention Type: DEVICE

T-shaped copper IUD

Interventions

SCu300A IUB

Spherical copper contraceptive

Intervention Type: DEVICE

TCu380A IUD

T-shaped copper IUD

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ocon Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Women's Health Center

Netanya, , Israel

Countries

Israel

Other Identifiers

AOS-2000-05

Identifier Type: -

Identifier Source: org_study_id