Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-03-03 @ 4:48 PM
Study NCT ID:
NCT01496105
Status:
UNKNOWN
Last Update Posted:
2011-12-21
First Post:
2011-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-20', 'studyFirstSubmitDate': '2011-12-13', 'studyFirstSubmitQcDate': '2011-12-20', 'lastUpdatePostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS score of Pain', 'timeFrame': '5 minutes from lidocaine spraying ( after application of tenaculum)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Drug Usage']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the topical use of lidocaine spray 10% on the cervix is an effective way to reduce pain during IUCD insertion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-45\n* Speak Arabic or English\n\nExclusion Criteria:\n\n* History of cervical surgery\n* Known hypersensitivity to topical analgesics\n* First trimester abortion or miscarriage in the previous six weeks\n* Second trimester abortion or miscarriage in the previous 12 weeks'}, 'identificationModule': {'nctId': 'NCT01496105', 'briefTitle': 'Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'orgStudyIdInfo': {'id': 'ali elyan 2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lidocaine spray 10%', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'interventionNames': ['Drug: saline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'armGroupLabels': ['lidocaine spray 10%']}, {'name': 'saline', 'type': 'DRUG', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Ibrahim Emeira, Lecturer', 'role': 'CONTACT', 'email': 'emeira2@gmail.com', 'phone': '+201224456471'}], 'facility': 'Ain shams university hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed S.Eldin Elsafty, Lecturer', 'role': 'CONTACT', 'email': 'emeira2@gmail.com', 'phone': '+201003922211'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology', 'investigatorFullName': 'Mohamed Saied Eldin Elsafty', 'investigatorAffiliation': 'Ain Shams University'}}}}