Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-20 @ 12:45 PM
Study NCT ID:
NCT02036203
Status:
WITHDRAWN
Last Update Posted:
2018-07-06
First Post:
2013-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Safety and Efficacy of the SCu300A IUB Compared to the TCu380 Copper IUD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': "The study was withdrawn prior to patients enrolment due to sponsor's decision", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2014-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-04', 'studyFirstSubmitDate': '2013-12-23', 'studyFirstSubmitQcDate': '2014-01-12', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perforation rate', 'timeFrame': 'During device insertion', 'description': 'Number of subjects with partial or complete perforation through the uterine wall'}, {'measure': 'Device expulsion', 'timeFrame': '12 months', 'description': 'Number of subjects with partially or fully ejected devices'}, {'measure': 'Efficacy in preventing pregnancy', 'timeFrame': '12 months', 'description': 'Number of women who become pregnant during the trial period.'}, {'measure': 'Device malposition', 'timeFrame': '12 months', 'description': 'Number of subjects with observed device malposition within the uterine cavity'}], 'secondaryOutcomes': [{'measure': 'Menorrhagia and dysmenorrhea rates', 'timeFrame': '12 months', 'description': 'Recording of menstrual pain, cramps and irregular bleeding as reported by subjects.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reversible Prevention of Pregnancy']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants will be followed for one year and quality of life measurements will be measured during this period as well.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\* Adult females aged 25-42\n\n* Free and willing to fully comply with treatment process\n* Healthy women seeking LARC\n* Married or in a steady relationship (at least 1 year)\n* Blood hemoglobin \\>11.5gr%\n* Signed informed consent form\n* If took COCP at least had one cycle after use of OC\n\nExclusion Criteria(major)\n\n* Use IUB/IUD as an emergency contraception\n* A previously placed IUD that has not been removed\n* Pregnancy or suspicion of pregnancy\n* Use of other contraception method (condom for either male or female, oral contraceptives, diaphragms, spermicides, hormonal patches, injections or ring, cervical cap)\n* History of pelvic inflammatory disease, recent or remote.\n* Postpartum endometritis or post abortal endometritis in the past 3 month\n* Mucopurulent cervicitis\n* Endometrial thickness more than 12 mm on insertion date\n* Known anemia\n* History of previous IUD complications\n* Dysfunctional uterine bleeding\n* Undiagnosed uterine bleeding\n* Malignancy or suspected malignant disease of female inner or outer genitalia\n* Distortions of the uterine cavity by uterine fibroids or known anatomical abnormalities\n* Known intolerance or allergy to nitinol or copper and/or copper IUDs - Wilson's disease.\n* Medication that may interfere with the subject's ability to complete the protocol\n* Use of injectable contraception in the previous year\n* Any other significant disease or condition that could interfere with the subject's ability to complete the protocol\n* A history of alcohol or drug abuse\n* Known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C\n* Pregnancy or pregnancy planned during the year\n* Enrollment (less than 30 days after completing another study) in or planned to be enrolled in another study"}, 'identificationModule': {'nctId': 'NCT02036203', 'briefTitle': 'A Study on the Safety and Efficacy of the SCu300A IUB Compared to the TCu380 Copper IUD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ocon Medical Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AOS-2000-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCu300A IUB', 'interventionNames': ['Device: SCu300A IUB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TCu380A', 'interventionNames': ['Device: TCu380A IUD']}], 'interventions': [{'name': 'SCu300A IUB', 'type': 'DEVICE', 'description': 'Spherical copper contraceptive', 'armGroupLabels': ['SCu300A IUB']}, {'name': 'TCu380A IUD', 'type': 'DEVICE', 'description': 'T-shaped copper IUD', 'armGroupLabels': ['TCu380A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'country': 'Israel', 'facility': "Women's Health Center", 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ocon Medical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}