[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651987":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":59,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Mount Sinai Hospital, Canada","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Medicated cream","EXPERIMENTAL","5g of 2.5% lidocaine\u002F2.5% prilocaine topical cream administered with vaginal self-applicator",[13],"Drug: 2.5% lidocaine\u002F2.5% prilocaine topical cream",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo cream","PLACEBO_COMPARATOR","5g of placebo VersaPro topical cream administered with vaginal self-applicator",[19],"Other: VersaPro Cream Base for Compounding",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","2.5% lidocaine\u002F2.5% prilocaine topical cream","5g of 2.5% lidocaine\u002F2.5% prilocaine topical cream administered by participant by vaginal self-applicator",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"VersaPro Cream Base for Compounding","5g of VersaPro cream administered by participant by vaginal self-applicator",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Mara Sobel, MD","CONTACT","416-586-8273","Mara.Sobel@sinaihealth.ca",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Ontario Power Generation Building","Toronto","Ontario","M5G1Z5","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-79.39864,43.70643,{"lat":49,"lon":48},[52,54,56],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":53},"mara.sobel@sinaihealth.ca",{"name":33,"role":55,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":57,"role":58,"phone":26,"phoneExt":26,"email":26},"Praniya Elangainesan, MD","SUB_INVESTIGATOR",{"type":55,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Mara Sobel","Principal Investigator","100651987","25-lidocaine25-prilocaine-cream-for-iud-insertion-and-endometrial-biopsy-100651987",false,"NCT07768059","2.5% Lidocaine\u002F2.5% Prilocaine Cream for IUD Insertion and Endometrial Biopsy","A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of Self-application of Lidocaine 2.5%\u002FPrilocaine 2.5% Cream for Intrauterine Device (IUD) Insertion and Endometrial Biopsy","Inclusion Criteria:\n\n* Any participant ≥18 years presenting for an IUD insertion or endometrial biopsy\n* English speaking participants only\n\nExclusion Criteria:\n\n* Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours\n* Misoprostol administration within 24 hours\n* Confirmed pregnancy\n* Any diagnosed chronic pain syndromes (e.g. fibromyalgia, vaginismus)\n* Allergy to lidocaine, prilocaine or any other \"-caine\" type anesthetics or any of the non-medicinal ingredients found in the product\n* Patients with congenital or idiopathic methemoglobinemia\n* Patients with glucose-6-phosphate dehydrogenase deficiency\n* Severe kidney or liver disease\n* Previous history of local anesthetic systemic toxicity (LAST)\n* Baseline vital signs of systolic blood pressure \\\u003C100, diastolic blood pressure \\\u003C60 and\u002For pulse \\\u003C60.\n* Previous unsuccessful office attempt of IUD insertion or endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful IUD insertion or biopsy attempt by a different practitioner will still be eligible)\n* Active atopic dermatitis or skin involving vulva, vagina and\u002For cervix.",true,"FEMALE","18 Years",{"count":73,"type":74},174,"ESTIMATED","INTERVENTIONAL",[77],"NA","The aim of this study is to determine if 5g of self-administered topical 2.5% lidocaine\u002F2.5% prilocaine cream, reduces pain during IUD insertion and\u002For endometrial biopsy. The proposed study is a double-blind, placebo-controlled RCT. Each participant will be randomly assigned to one of two arms: 1) Intervention (5g of 2.5% lidocaine\u002F2.5% prilocaine cream in a pre-filled vaginal applicator). 2) Placebo (5g of VersaPro cream in a pre-filled vaginal applicator). Participants will be asked to self-administer the pre-filled vaginal applicator at least 10-15 minutes prior to the procedure. The patient will be asked to rate their pain throughout various steps of the procedure and complete a post-procedure survey afterwards. The primary outcome is global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) 5-minutes following the procedure (endometrial biopsy or IUD insertion).",[80,81],"IUD","Endometrial Biopsy",[83,84,85,86],"pain management","iud insertion","endometrial biopsy","gynecology","NOT_YET_RECRUITING","2026-08-11",{"date":90,"type":91},"2026-08-17","ACTUAL",{"date":93,"type":74},"2026-07-30",{"date":95,"type":74},"2027-12-31",{"name":5,"class":6},1]