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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Single Blind, Two Arms Controlled Study of the Safety and Efficacy of the SCu300A IUB™ Spherical Copper Intrauterine Ball in Comparison to TCu 380 IUD Intra-uterine Contraceptive Device

Conditions
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Reversible Prevention of Pregnancy

Intervention / Treatment
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* Device: SCu300A IUB
* Device: TCu380A IUD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCu300A IUB<br> | Device: SCu300A IUB<br>* Spherical copper contraceptive<br>|
| Active Comparator: TCu380A<br> | Device: TCu380A IUD<br>* T-shaped copper IUD<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menorrhagia and dysmenorrhea rates | Recording of menstrual pain, cramps and irregular bleeding as reported by subjects. | 12 months |