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

Ocon Medical

Status and phase

Completed

Phase 4

Conditions

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

Treatments

Device: T380A IUD

Device: SCu300A IUB intrauterine device

Study type

Interventional

Funder types

Industry

Identifiers

NCT02036177

AOS-C2000

Details and patient eligibility

About

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.

Enrollment

366 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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