Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-01-23 @ 1:19 AM
Study NCT ID:
NCT02738203
Status:
COMPLETED
Last Update Posted:
2019-06-06
First Post:
2016-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self-Administered Lidocaine Gel for Pain Management With IUD Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'C042973', 'term': 'K-Y jelly'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'familyplanningresearch@stanford.edu', 'phone': '6507211562', 'title': 'Research Manager', 'organization': 'Stanford University, Department of OB/GYN'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data for each subject was assessed from time of consent to time of appointment discharge. On average this was 90 minutes.', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental, IUD Insertion Group', 'description': 'If the subject is assigned to the experimental group (vaginal lidocaine jelly):\n\nShe will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nVaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 0, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control, IUD Insertion Group', 'description': 'If the subject is assigned to the control group (sterile, surgical lubricant jelly):\n\n•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nSurgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 0, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '(IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental, IUD Insertion Group', 'description': 'If the subject is assigned to the experimental group (vaginal lidocaine jelly):\n\nShe will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nVaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly'}, {'id': 'OG001', 'title': 'Control, IUD Insertion Group', 'description': 'If the subject is assigned to the control group (sterile, surgical lubricant jelly):\n\n•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nSurgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '99'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0-3 minutes after procedure completed', 'description': 'Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Anticipated Pain as Measured by a Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental, IUD Insertion Group', 'description': 'If the subject is assigned to the experimental group (vaginal lidocaine jelly):\n\nShe will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nVaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly'}, {'id': 'OG001', 'title': 'Control, IUD Insertion Group', 'description': 'If the subject is assigned to the control group (sterile, surgical lubricant jelly):\n\n•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nSurgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '87'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '94'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 Minutes prior to procedure', 'description': 'Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Baseline Pain as Measured by a Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental, IUD Insertion Group', 'description': 'If the subject is assigned to the experimental group (vaginal lidocaine jelly):\n\nShe will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nVaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly'}, {'id': 'OG001', 'title': 'Control, IUD Insertion Group', 'description': 'If the subject is assigned to the control group (sterile, surgical lubricant jelly):\n\n•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nSurgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '77'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately prior to procedure; upon arrival to procedure room', 'description': 'Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Pain After Speculum Placement as Measured by a Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental, IUD Insertion Group', 'description': 'If the subject is assigned to the experimental group (vaginal lidocaine jelly):\n\nShe will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nVaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly'}, {'id': 'OG001', 'title': 'Control, IUD Insertion Group', 'description': 'If the subject is assigned to the control group (sterile, surgical lubricant jelly):\n\n•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nSurgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '81'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Intraoperative', 'description': 'Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Pain After Tenaculum Placement as Measured by a Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental, IUD Insertion Group', 'description': 'If the subject is assigned to the experimental group (vaginal lidocaine jelly):\n\nShe will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nVaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly'}, {'id': 'OG001', 'title': 'Control, IUD Insertion Group', 'description': 'If the subject is assigned to the control group (sterile, surgical lubricant jelly):\n\n•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nSurgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '86'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Intraoperative', 'description': 'Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental, IUD Insertion Group', 'description': 'If the subject is assigned to the experimental group (vaginal lidocaine jelly):\n\nShe will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nVaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly'}, {'id': 'FG001', 'title': 'Control, IUD Insertion Group', 'description': 'If the subject is assigned to the control group (sterile, surgical lubricant jelly):\n\n•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nSurgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Failed IUD Insertion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental, IUD Insertion Group', 'description': 'If the subject is assigned to the experimental group (vaginal lidocaine jelly):\n\nShe will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nVaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly'}, {'id': 'BG001', 'title': 'Control, IUD Insertion Group', 'description': 'If the subject is assigned to the control group (sterile, surgical lubricant jelly):\n\n•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.\n\nSurgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '48'}, {'value': '27', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '51'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '51'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous Intrauterine Device Insertion', 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participant had a previous intrauterine device insertion.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Per protocol analysis'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-01', 'size': 177181, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-14T14:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-04', 'studyFirstSubmitDate': '2016-04-04', 'resultsFirstSubmitDate': '2018-08-07', 'studyFirstSubmitQcDate': '2016-04-13', 'lastUpdatePostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-17', 'studyFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '(IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion', 'timeFrame': '0-3 minutes after procedure completed', 'description': 'Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.'}], 'secondaryOutcomes': [{'measure': 'Anticipated Pain as Measured by a Visual Analog Scale', 'timeFrame': '30 Minutes prior to procedure', 'description': 'Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.'}, {'measure': 'Baseline Pain as Measured by a Visual Analog Scale', 'timeFrame': 'Immediately prior to procedure; upon arrival to procedure room', 'description': 'Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.'}, {'measure': 'Pain After Speculum Placement as Measured by a Visual Analog Scale', 'timeFrame': 'Intraoperative', 'description': 'Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.'}, {'measure': 'Pain After Tenaculum Placement as Measured by a Visual Analog Scale', 'timeFrame': 'Intraoperative', 'description': 'Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain Management', 'IUD insertion'], 'conditions': ['IUD Insertion']}, 'referencesModule': {'references': [{'pmid': '30444982', 'type': 'DERIVED', 'citation': 'Conti JA, Lerma K, Schneyer RJ, Hastings CV, Blumenthal PD, Shaw KA. Self-administered vaginal lidocaine gel for pain management with intrauterine device insertion: a blinded, randomized controlled trial. Am J Obstet Gynecol. 2019 Feb;220(2):177.e1-177.e7. doi: 10.1016/j.ajog.2018.11.1085. Epub 2018 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nElective IUD insertion (any type of IUD, copper or hormonal); at an out-patient setting at Stanford; English or Spanish speaking, and ability to give informed consent.\n\nExclusion Criteria:\n\nAny pre-operative use of misoprostol; or use of PO pain control medication (i.e. ibuprofen or acetaminophen) prior to procedure. Allergy to study medications: lidocaine, or surgical lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of tampons.'}, 'identificationModule': {'nctId': 'NCT02738203', 'acronym': 'SALUD', 'briefTitle': 'Self-Administered Lidocaine Gel for Pain Management With IUD Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Self-Administered Lidocaine Gel for Pain Management With IUD Insertion: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '32825'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental, IUD Insertion group', 'description': 'If the subject is assigned to the experimental group (vaginal lidocaine jelly):\n\nShe will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.', 'interventionNames': ['Drug: Vaginal 2% Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control, IUD Insertion group', 'description': 'If the subject is assigned to the control group (sterile, surgical lubricant jelly):\n\n•She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.', 'interventionNames': ['Drug: Surgical Lubricant Jelly']}], 'interventions': [{'name': 'Vaginal 2% Lidocaine', 'type': 'DRUG', 'description': 'Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly', 'armGroupLabels': ['Experimental, IUD Insertion group']}, {'name': 'Surgical Lubricant Jelly', 'type': 'DRUG', 'otherNames': ['K-Y Jelly'], 'description': 'Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly', 'armGroupLabels': ['Control, IUD Insertion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Gynecology Clinic', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Jennifer A Conti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Instructor', 'investigatorFullName': 'Jennifer Conti', 'investigatorAffiliation': 'Stanford University'}}}}