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

Ocon Medical

Status: Withdrawn

Conditions: Reversible Prevention of Pregnancy

Treatments: Device: TCu380A IUD; Device: SCu300A IUB

Study type: Interventional

Funder types: Industry

Identifiers

NCT02036203

AOS-2000-05

Details and patient eligibility

About

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.

Sex: Female

Ages: 25 to 42 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

SCu300A IUB

Experimental group

Treatment:

Device: SCu300A IUB

TCu380A

Active Comparator group

Treatment:

Device: TCu380A IUD