[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584626":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":62,"collaborators":42,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":42,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":42,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Oregon Health and Science University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Menstrual disc","EXPERIMENTAL","Participants will be provided with a menstrual disc filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for placement. Study personnel will leave the room, and participants will undress and attempt to place the disc. The provider will return to the room, make sure the disc is correctly placed, and set a seven minute timer. After the seven minute timer, participants will self-remove the disc or the clinician will remove it and place the intrauterine device (IUD) according to manufacturer technique.",[13],"Combination Product: Menstrual disc with EMLA cream",{"label":15,"type":10,"description":16,"interventionNames":17},"Cervical cap","Participants will be provided with a cervical cap filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for placement. Study personnel will leave the room, and participants will undress and attempt to place the cap. The provider will return to the room, make sure the cap is correctly placed, and set a seven minute timer. After the seven minute timer, participants will self-remove the cap or the clinician will remove it and place the intrauterine device (IUD) according to manufacturer technique.",[18],"Combination Product: Cervical cap with EMLA cream",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","Menstrual disc with EMLA cream","Eutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc",[9],[26,27],"2.5% prilocaine-2.5% lidocaine cream","Softdisc",{"type":21,"name":29,"description":23,"armGroupLabels":30,"otherNames":31},"Cervical cap with EMLA cream",[15],[32,26],"FemCap",[34],{"name":35,"affiliation":5,"role":36},"Julia Tasset","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Women's Health Research Unit Department of Ob\u002FGyn","CONTACT","503-494-3666",null,"whru@ohsu.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Oregon Health & Science University","RECRUITING","Portland","Oregon","97239","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-122.67621,45.52345,{"lat":57,"lon":56},[60],{"name":61,"role":40,"phone":41,"phoneExt":42,"email":43},"Women's Health Research Unit",{"type":36,"investigatorFullName":35,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Principal Investigator","100584626","use-of-cervical-cap-and-menstrual-disc-for-application-of-topical-anesthetic-prior-to-iud-insertion-100584626",false,"NCT06891794","Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion","Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to Intrauterine Device (IUD) Insertion","Inclusion Criteria:\n\n* Scheduled for IUD placement at the Center for Women's Health in Complex Family Planning clinic\n* Able to review and sign study consents in English\n* Generally healthy\n\nExclusion Criteria:\n\n* History of any prior births, miscarriages, or abortions after 16 weeks' gestation\n* Currently pregnant, known or suspected\n* Current stringless IUD in place\n* Participants premedicated with misoprostol\n* History of chronic pelvic pain which patients take daily medication for\n* History of endometriosis, fibroids, adenomyosis, prior cervical procedures (such as Loop Electrosurgical Excision Procedure (LEEP) or cold knife cone)\n* Any contraindications to IUD placement (per current labeling including pregnancy, fibroids that distort the uterine cavity, exam consistent with pelvic inflammatory disease, allergy to any component of the levonorgestrel intrauterine system (LNG-IUS), etc.)\n* Known allergy to eutectic mixture of local anesthetics (EMLA) or lidocaine cream, silicone, menstrual disc, or cervical cap\n* Any contraindication to EMLA or lidocaine cream, menstrual disc, or cervical cap\n* Previous IUD placement or failed attempt of an IUD placement\n* Weight \\\u003C 54.4kg (120 lbs)\n* Plan for use of oral anxiolysis, moderate\u002Fdeep sedation, or narcotics for procedure\n* Patient requesting or patient use in the past 24 hours of oral anxiolysis, moderate\u002Fdeep sedation, or narcotics\n* Any planned concomitant procedures, such as dilation and curettage (D\\&C), endometrial biopsy, colposcopy, hysteroscopy, etc.\n* Illicit drug use","FEMALE","18 Years","45 Years",{"count":75,"type":76},24,"ESTIMATED","INTERVENTIONAL",[79],"NA","This prospective, open label, double arm, feasibility group study will recruit participants planning to undergo office intrauterine device (IUD) placement without sedation or anxiolysis at the Center for Women's Health. Participants will self-administer a topical anesthetic using a contraceptive cervical cap or menstrual disc.\n\nTwenty-four nulliparous women will be recruited to receive one of two administration methods immediately prior to IUD placement (12 subjects in each arm): 1) menstrual disc filled with 5g eutectic mixture of local anesthetics (EMLA) cream or 2) cervical cap filled with 5g EMLA cream.",[82],"IUD",[84,85],"Topical Anesthetic","IUD Insertion","2025-08-04",{"date":88,"type":89},"2025-08-08","ACTUAL",{"date":86,"type":89},{"date":92,"type":76},"2026-04",{"name":5,"class":6},1]