Study Stopped
The study was withdrawn prior to patients enrolment due to sponsor's decision
A Study on the Safety and Efficacy of the SCu300A IUB Compared to the TCu380 Copper IUD
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2013
CompletedFirst Posted
Study publicly available on registry
January 14, 2014
CompletedStudy Start
First participant enrolled
January 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2014
CompletedJuly 6, 2018
July 1, 2018
Same day
December 23, 2013
July 4, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Menorrhagia and dysmenorrhea rates
12 months
Study Arms (2)
SCu300A IUB
EXPERIMENTALTCu380A
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \* 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
You may not qualify if:
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's Health Center
Netanya, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2013
First Posted
January 14, 2014
Study Start
January 14, 2014
Primary Completion
January 14, 2014
Study Completion
January 14, 2014
Last Updated
July 6, 2018
Record last verified: 2018-07