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

NCT ID: NCT02036177

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-12
• Study Completion Date: 2017-07-15

Brief Summary

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.

Conditions

To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB

Study Design

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

Study Groups

SCu300A IUB

Group Type: EXPERIMENTAL

SCu300A IUB intrauterine device

Intervention Type: DEVICE

Spherical copper IUD

T380A copper IUD

Group Type: ACTIVE_COMPARATOR

T380A IUD

Intervention Type: DEVICE

T-shaped copper IUD

Interventions

SCu300A IUB intrauterine device

Spherical copper IUD

Intervention Type: DEVICE

T380A IUD

T-shaped copper IUD

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ocon Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sofia, , Bulgaria

Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie

Bucharest, , Romania

Countries

Bulgaria; Romania

Other Identifiers

AOS-C2000

Identifier Type: -

Identifier Source: org_study_id