[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625933":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":23,"locations":32,"responsibleParty":62,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":11,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":35,"whyStopped":11,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL",null,[13],"Combination Product: Papilocare Vaginal Gel",{"label":15,"type":16,"description":11,"interventionNames":11},"Control","NO_INTERVENTION",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"COMBINATION_PRODUCT","Papilocare Vaginal Gel","Women (n=35) will apply a CV-based vaginal gel (Papilocare®) daily for 21 days for 3 months. Afterward, the gel should be used every other day for an additional 3 months. Every month includes a 7-day break due to menstruation (28 days cycle).",[9],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Pinar Bor, Professor, MD, Ph.D.","CONTACT","22504767","isipinbo@rm.dk",{"name":30,"role":26,"phone":11,"phoneExt":11,"email":31},"Vibe M Bertelsen, Post.Doc, MD, Ph.D.","vibebert@rm.dk",[33,51],{"facility":34,"status":35,"city":36,"state":11,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Department of Gynaecology and Obstetrics","RECRUITING","Horsens","8700","Denmark","DK",{"type":41,"coordinates":42},"Point",[43,44],9.85034,55.86066,{"lat":44,"lon":43},[47],{"name":48,"role":26,"phone":49,"phoneExt":11,"email":50},"Mathilde K Kristensen, Medical student","42199674","makrki@rm.dk",{"facility":34,"status":35,"city":52,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Randers",{"type":41,"coordinates":54},[55,56],10.03639,56.4607,{"lat":56,"lon":55},[59],{"name":60,"role":26,"phone":61,"phoneExt":11,"email":50},"Mathilde Kristine Kristensen, Medical student","+4542199674",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Vibe Munk Bertelsen","Post.doc, MD, Ph.D",[67],{"name":68,"class":69},"Procare Health Iberia S.L.","INDUSTRY","100625933","effectiveness-of-a-vaginal-gel-on-cin12-regression-and-hpv-clearance-100625933",false,"NCT07429071","Effectiveness of a Vaginal Gel on CIN1\u002F2 Regression and HPV Clearance.","Effectiveness of Coriolus Versicolor-based Vaginal Gel on HPV Clearance and Regression of Cervical Intraepithelial Neoplasia: a Multicenter Randomized Controlled Trial","Inclusion criteria:\n\n* Aged 30-50 years\n* A positive hrHPV test with histopathological confirmed CIN1 or CIN2\n* Managed under a 'watchful waiting' strategy as part of standard management\n* Understand Danish, both written and orally\n\nExclusion criteria:\n\n* Pregnancy or breastfeeding\n* Unexplained vaginal bleeding\n* Immunosuppressive or immunomodulatory conditions or treatment\n* Diabetes mellitus\n* Prior hysterectomy\n* Any ongoing cancer diagnosis, prior CIN3 or a history of malignancy in the genital\u002Fanal region within 5 years (excl. non-melanoma skin cancer)","FEMALE","30 Years","50 Years",{"count":81,"type":82},70,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this clinical trial is to evaluate whether a Coriolus versicolor-based vaginal gel facilitates HPV clearance in women aged 30-50 years diagnosed with HPV and CIN1 or CIN2. In addition, the study will investigate whether the gel promotes regression of CIN1\u002FCIN2, assessment of patient satisfaction, treatment compliance and characterize the vaginal microbiome.\n\nThe primary outcomes therefore is:\n\n• hrHPV clearance from baseline to follow-up (6 months)\n\nIn this randomized controlled study, eligible participants will be randomized 1:1 into two groups:\n\n1. Intervention group: Women (n=35) will apply a CV-based vaginal gel (Papilocare®) daily for 21 days for 3 months. Afterward, the gel should be used every other day for an additional 3 months. Every month includes a 7-day break due to menstruation (28 days cycle).\n2. Control group; Women (n=35) will follow the conventional \"wait and see\" approach.",[88,89,90,91,92],"Womens Health","Cervical Dysplasia","Cervical Intraepithelial Neoplasia (CIN)","Non-invasive Treatment","Human Papilloma Virus (HPV)",[88,89,90,94,95],"Human Papillomavirus (HPV)","Non-Invasive Treatments","2026-07-31",{"date":98,"type":99},"2026-08-03","ACTUAL",{"date":101,"type":99},"2026-06-09",{"date":103,"type":82},"2026-12",{"name":5,"class":6},2]