Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT00689494
Status:
UNKNOWN
Last Update Posted:
2008-06-03
First Post:
2008-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Device Contraception-2 (Nanopaz)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-06-02', 'studyFirstSubmitDate': '2008-05-19', 'studyFirstSubmitQcDate': '2008-06-02', 'lastUpdatePostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood progesterone measure in blood', 'timeFrame': 'one to two months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nanopaz device', 'Blood progesterone measure in using the device', 'Delivery progesterone', 'Progesterone levonorgestrel'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Measure blood progesterone by using cervical device contraception.', 'detailedDescription': 'A very small cervical device that releases small amount of progesterone 20 mcgm/day.\n\nThe target of the research is to measure blood progesterone by using the cervical device.\n\nThis small device delivers progesterone by nanotechnology method.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'minimumAge': '1 Month', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 10 healthy women are candidate for hysterectomy\n\nExclusion Criteria:\n\n* Women with neoplastic malignancy disease or thrombophylia'}, 'identificationModule': {'nctId': 'NCT00689494', 'acronym': 'NANOPAZ', 'briefTitle': 'Cervical Device Contraception-2 (Nanopaz)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bnai Zion Medical Center'}, 'officialTitle': 'Cervical Device Contraception', 'orgStudyIdInfo': {'id': 'BnaiZionMC-08-BP-003-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nanopaz contraception device', 'type': 'OTHER', 'otherNames': ['levonorgestrel device for cervical contraception-nantechnolgy method'], 'description': 'levonorgestrel and levonorgestrel device for cervical contraception-nantechnolgy method'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bnai Zion Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Baram Paz', 'oldOrganization': 'Bnai Zion MC'}}}}