Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-17 @ 11:43 AM
Study NCT ID:
NCT03187392
Status:
UNKNOWN
Last Update Posted:
2018-02-27
First Post:
2017-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Relief for Birth Control Implants Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-09-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-25', 'studyFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2017-06-13', 'lastUpdatePostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean pain score during insertion of implant', 'timeFrame': '10 minutes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraception', 'Lidocaine']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during insertion of birth control implants'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female want use subcutaneous birth control\n\nExclusion Criteria:\n\n* previous scar at side of insertion'}, 'identificationModule': {'nctId': 'NCT03187392', 'briefTitle': 'Pain Relief for Birth Control Implants Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Topical Lidocaine-prilocaine Cream Versus Lidocaine Infiltration for Pain Relief During Insertion of Subcutaneous Birth Control Implants : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '123456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lidocaine injection', 'interventionNames': ['Drug: Lidocaine Injectable Product']}, {'type': 'EXPERIMENTAL', 'label': 'lidocaine-prilocaine cream', 'interventionNames': ['Drug: Lidocaine Topical Cream [LMX]']}], 'interventions': [{'name': 'Lidocaine Injectable Product', 'type': 'DRUG', 'description': '3 cm of Lidocaine- will be injected subcutaneous for 5 minutes before insertion of subcutaneous birth control implant', 'armGroupLabels': ['lidocaine injection']}, {'name': 'Lidocaine Topical Cream [LMX]', 'type': 'DRUG', 'description': '3 mg of Lidocaine- will be applied to skin for 5 minutes before insertion of subcutaneous birth control implant', 'armGroupLabels': ['lidocaine-prilocaine cream']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident physician', 'investigatorFullName': 'Armia Michael', 'investigatorAffiliation': 'Assiut University'}}}}