Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT02708251
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2016-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glyceryl Trinitrate Versus Lidocaine Cream for 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-11', 'studyFirstSubmitDate': '2016-03-10', 'studyFirstSubmitQcDate': '2016-03-10', 'lastUpdatePostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean pain score during IUD insertion', 'timeFrame': '3 minutes'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction score after the procedure', 'timeFrame': '3 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['IUD Insertion']}, 'referencesModule': {'references': [{'pmid': '30898632', 'type': 'DERIVED', 'citation': 'Abbas AM, Ragab E, Abd Ellah NH, Sabra A, Ali SS, Mohamed A, Yosef AH. Effect of topical glyceryl trinitrate cream on pain perception during intrauterine device insertion in multiparous women: A randomized double-blinded placebo-controlled study. J Gynecol Obstet Hum Reprod. 2019 Nov;48(9):715-718. doi: 10.1016/j.jogoh.2019.03.007. Epub 2019 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive method that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Women not taken analgesics or anxiolytics in the 24 hours prior insertion\n2. Women not taken misoprostol prior to IUD insertion\n3. No contraindication to or history of allergic reaction to lidocaine or NO donors.\n4. Women who will accept to participate in the study\n\nExclusion criteria:\n\n1. Lidocaine allergy\n2. History of migraine or chronic headache\n3. Any contraindication to IUD placement'}, 'identificationModule': {'nctId': 'NCT02708251', 'acronym': 'GTN-IUD', 'briefTitle': 'Glyceryl Trinitrate Versus Lidocaine Cream for IUD Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Topical Glyceryl Trinitrate Versus Lidocaine Cream as Analgesia for IUD Insertion: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GTN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'glyceryl trinitrate cream', 'description': 'The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine. 1 mL glyceryl trinitrate cream will be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab.', 'interventionNames': ['Drug: glyceryl trinitrate cream']}, {'type': 'EXPERIMENTAL', 'label': 'lidocaine cream', 'description': 'The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine. 1 mL lidocaine creamwill be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab.', 'interventionNames': ['Drug: lidocaine cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo cream', 'description': 'The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine.1 mL placebo cream will be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab.', 'interventionNames': ['Drug: placebo cream']}], 'interventions': [{'name': 'glyceryl trinitrate cream', 'type': 'DRUG', 'armGroupLabels': ['glyceryl trinitrate cream']}, {'name': 'lidocaine cream', 'type': 'DRUG', 'armGroupLabels': ['lidocaine cream']}, {'name': 'placebo cream', 'type': 'DRUG', 'armGroupLabels': ['placebo cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Assiut', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ahmed Abbas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}