Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01534520
Status:
COMPLETED
Last Update Posted:
2016-12-22
First Post:
2012-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'dbest@upmc.edu', 'phone': '412-641-5496', 'title': 'Dionne Best', 'organization': 'UPittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Intravaginal insertion of 4mL placebo gel\n\nPlacebo: KY Jelly', 'otherNumAtRisk': 29, 'otherNumAffected': 1, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Study Drug', 'description': 'Intravaginal insertion of 4mL 2% lidocaine gel\n\nLidocaine: Intravaginal insertion of 4mL 2% lidocaine gel', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Intolerable Pain', 'notes': 'Pain at time of IUD insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain From Baseline to IUD Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Intravaginal 2% Lidocaine Gel', 'description': 'Intravaginal insertion of 4mL of 2% lidocaine gel\n\nPlacebo: KY Jelly'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Placebo Gel', 'description': 'Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)\n\nLidocaine: Intravaginal insertion of 5mL 2% lidocaine gel'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '71'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '58', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'change in pain score from baseline (before IUD insertion) to time of IUD insertion', 'description': "To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient's life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel).", 'unitOfMeasure': 'change in visual analog scale score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Intravaginal 2% Lidocaine Gel', 'description': 'Intravaginal insertion of 4mL of 2% lidocaine gel\n\nPlacebo: KY Jelly'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Placebo Gel', 'description': 'Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)\n\nLidocaine: Intravaginal insertion of 5mL 2% lidocaine gel'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After inserting the gel but prior to IUD insertion', 'description': 'Number of participants who rated self-application of study gel as "some what easy" or "very easy" on Likert scale', 'unitOfMeasure': 'participants who found gel easy to use', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of IUDs Considered by Physicians Easy to Insert', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Intravaginal 2% Lidocaine Gel', 'description': 'Intravaginal insertion of 4mL of 2% lidocaine gel\n\nLidocaine: Intravaginal insertion of 4mL 2% lidocaine gel'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Placebo Gel', 'description': 'Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)\n\nPlacebo: KY Jelly'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '96'}, {'value': '64', 'groupId': 'OG001', 'lowerLimit': '44', 'upperLimit': '81'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Directly after IUD insertion', 'description': 'The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be "easy" was calculated for each study group.', 'unitOfMeasure': 'percentage of insertions declared easy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in each group self-administered the study gel as per instruction followed by insertion of the IUD by the physician 5 to 15 minutes later.'}, {'type': 'SECONDARY', 'title': 'Need for Pain Medication up to 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Intravaginal 2% Lidocaine Gel', 'description': '4 ml of 2% lidocaine gel for self vaginal insertion'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Placebo Gel', 'description': 'Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days post-insertion', 'description': 'Number of women taking pain medication for at least one day following IUD insertion', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Intravaginal 2% Lidocaine Gel', 'description': '4 ml of 2% lidocaine gel for self vaginal insertion'}, {'id': 'FG001', 'title': 'Group 2: Intravaginal Placebo Gel', 'description': 'Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'comment': '1 subject withdrew consent at time of uterine sound attempt due to intolerable pain', 'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'In total, 79 women presenting for IUD insertion at OPC, UPP, and GMO were approached for participation.', 'preAssignmentDetails': '* 2 patients were removed from the study. Patients were considered screen failures before randomization to an arm.\n* 18 declined participation; 10 (56%) reported "time concerns" as their primary reason for declining.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Intravaginal 2% Lidocaine Gel', 'description': '4mL of 2% lidocaine gel for vaginal self-administration\n\n)'}, {'id': 'BG001', 'title': 'Group 2: Intravaginal Placebo Gel', 'description': '4mL placebo gel (K-Y Jelly) for vaginal self-administration'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 14-50', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Randomization was blinded.', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomization is blinded.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2012-02-13', 'resultsFirstSubmitDate': '2016-05-20', 'studyFirstSubmitQcDate': '2012-02-13', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-27', 'studyFirstPostDateStruct': {'date': '2012-02-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain From Baseline to IUD Insertion', 'timeFrame': 'change in pain score from baseline (before IUD insertion) to time of IUD insertion', 'description': "To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient's life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel)."}], 'secondaryOutcomes': [{'measure': 'To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD', 'timeFrame': 'After inserting the gel but prior to IUD insertion', 'description': 'Number of participants who rated self-application of study gel as "some what easy" or "very easy" on Likert scale'}, {'measure': 'Percentage of IUDs Considered by Physicians Easy to Insert', 'timeFrame': 'Directly after IUD insertion', 'description': 'The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be "easy" was calculated for each study group.'}, {'measure': 'Need for Pain Medication up to 7 Days', 'timeFrame': '7 days post-insertion', 'description': 'Number of women taking pain medication for at least one day following IUD insertion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intrauterine Device', 'Pain', 'Lidocaine'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '27500351', 'type': 'DERIVED', 'citation': 'Rapkin RB, Achilles SL, Schwarz EB, Meyn L, Cremer M, Boraas CM, Chen BA. Self-Administered Lidocaine Gel for Intrauterine Device Insertion in Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2016 Sep;128(3):621-8. doi: 10.1097/AOG.0000000000001596.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.', 'detailedDescription': 'Intrauterine devices (IUDs) are among the most effective forms of reversible contraception. Numerous studies demonstrate their safety and efficacy in nulliparous women, however, uptake of IUDs in this group is low. One of the major barriers to women obtaining IUDs is fear of pain during insertion, as studies do demonstrate that nulliparous women experience more pain than parous women during IUD insertion. Studies evaluating various methods for pain control during IUD insertion have shown conflicting results, leaving the question unanswered as to what is the best method to decrease pain during IUD insertion.\n\nThis study aims to evaluate a novel approach to pain control by having women self-insert lidocaine gel into the vagina at least 5 minutes prior to IUD insertion. This will overcome some of the barriers from other studies where there may not have been ample time for the lidocaine to take effect, while at the same time eliminating the need for women to have multiple speculum exams. Although this is a novel approach to administering an anesthetic, we believe women will be interested in any intervention that may potentially alleviate pain during IUD insertion.\n\nIf this study does demonstrate that pain is decreased with self-inserted lidocaine compared to placebo gel, this will potentially eliminate one large barrier to nulliparous women receiving IUDs. Increased uptake of highly effective contraception in nulliparous women is just one of the many steps necessary towards decreasing unintended pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age\n* Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD)\n* No history of pregnancy in the last 6 weeks\n* Able to provide written informed consent in English and comply with all study procedures\n\nExclusion criteria:\n\n* Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics\n* Prior failed IUD insertion\n* Prior IUD use\n* Use of narcotic or benzodiazepine medication within the last 24 hours\n* U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD\n* Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period'}, 'identificationModule': {'nctId': 'NCT01534520', 'acronym': 'LIVIIN', 'briefTitle': 'Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SFP-RBR001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Intravaginal 2% lidocaine gel', 'description': 'Intravaginal insertion of 4mL of 2% lidocaine gel', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2: Intravaginal placebo gel', 'description': 'Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['Lidocaine Jelly', 'Lidocaine Hydrochloride'], 'description': 'Intravaginal insertion of 4mL 2% lidocaine gel', 'armGroupLabels': ['Group 1: Intravaginal 2% lidocaine gel']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['K-Y Jelly', 'water based lubricant'], 'description': 'KY Jelly', 'armGroupLabels': ['Group 2: Intravaginal placebo gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee-Womens Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Rachel B Rapkin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sharon Achilles', 'investigatorAffiliation': 'University of Pittsburgh'}}}}