Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT04339361
Status:
UNKNOWN
Last Update Posted:
2020-04-09
First Post:
2020-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in IUD Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 111}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-07', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-07', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain during IUD insertion', 'timeFrame': '2 minutes', 'description': 'pain during IUD insertion assessed by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst pain imaginable'}], 'secondaryOutcomes': [{'measure': 'insertion duration', 'timeFrame': '5 minutes', 'description': 'duration of LNG-IUD insertion from speculum in to speculum out'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'the aim of this study is to compare the safety and Efficacy of Lidocaine Spray Versus Vaginal dinoprostone in relieving pain during levonorgestrel IUD Insertion in nulliparous women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nulliparous women requesting levonorgestrel IUD insertion\n\nExclusion Criteria:\n\n* multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion'}, 'identificationModule': {'nctId': 'NCT04339361', 'briefTitle': 'Comparative Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in IUD Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Safety and Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in Relieving Pain During Levonorgestrel IUD Insertion', 'orgStudyIdInfo': {'id': 'lidocaine spray IUD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lidocaine spray', 'description': 'four puffs (50ml, 10 mg/puff) of lidocaine spray will be applied to the cervical canal and cervix before tenaculum placement plus vaginal placebo will be given 3 hours before IUD insertion', 'interventionNames': ['Drug: lidocaine spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vaginal dinoprostone', 'description': 'vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement', 'interventionNames': ['Drug: vaginal dinoprostone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'lidocaine spray', 'type': 'DRUG', 'description': 'four puffs (50 ml, 10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion', 'armGroupLabels': ['lidocaine spray']}, {'name': 'vaginal dinoprostone', 'type': 'DRUG', 'description': 'vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement', 'armGroupLabels': ['vaginal dinoprostone']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'AHMED SAMY', 'role': 'CONTACT', 'email': 'ahmedsamy8233@gmail.com', 'phone': '+201100681167'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor obstetrics and gynecology', 'investigatorFullName': 'Ahmed Samy aly ashour', 'investigatorAffiliation': 'Cairo University'}}}}