[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100424510":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":30,"interventions":40,"overallOfficials":17,"centralContacts":46,"locations":52,"responsibleParty":68,"collaborators":70,"id":73,"slug":17,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":17,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":17,"enrollmentInfo":81,"targetDuration":17,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":17,"overallStatus":55,"whyStopped":17,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},{"fullName":5,"class":6},"Karo Pharma AB","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2).","Clinical cure is defined based on the following Amsel criteria:\n\n1. presence of clue cells \\\u003C20% of the total epithelial cells on microscopic examination of the saline wet mount\n2. resolution of the abnormal vaginal discharge, and\n3. a negative whiff test","3 weeks",[14],{"measure":15,"description":16,"timeFrame":12},"Microbiological cure rate (based on Nugent score \u003C4) at Visit 2","The secondary objective of the study is to confirm the secondary efficacy of the product.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","double blinded, randomized placebo controlled.","TREATMENT",{"masking":24,"maskingDescription":17,"whoMasked":25},"QUADRUPLE",[26,27,28,29],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[31,36],{"label":32,"type":33,"description":17,"interventionNames":34},"Active product","OTHER",[35],"Device: vaginal gel",{"label":37,"type":38,"description":17,"interventionNames":39},"Placebo","PLACEBO_COMPARATOR",[35],[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":17},"DEVICE","vaginal gel","The placebo gel is a non-buffered gel. The active device is an acidic gel.",[32,37],[47],{"name":48,"role":49,"phone":50,"phoneExt":17,"email":51},"Diana Zeneli, MD","CONTACT","0031614706949","diana.pasho@karopharma.com",[53],{"facility":54,"status":55,"city":56,"state":17,"zip":17,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Praxis Dr. Peters","RECRUITING","Hamburg","Germany","DE",{"type":60,"coordinates":61},"Point",[62,63],9.99302,53.55073,{"lat":63,"lon":62},[66],{"name":67,"role":49,"phone":17,"phoneExt":17,"email":17},"Klaus H Peters, Dr.med",{"type":69,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[71],{"name":72,"class":6},"Avania","100424510",false,"NCT04807842","Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis","A Double-blind, Randomized, Placebo-controlled Study to Confirm the Efficacy and Safety of Multi- Gyn ActiGel Plus for Treatment of Bacterial Vaginosis","Inclusion Criteria:\n\n* Women diagnosed with BV (3 out of 4 Amsel criteria positive, with at least presence of clue cells (\\>20%))\n* Women of childbearing potential\n* Aged \\>18 years\n* Signed written informed consent form\n* Willing to comply to the follow-up schedule\n\nExclusion Criteria:\n\n* Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)\n* Presence of Trichomonas and\u002For Candida Albicans in vaginal smear during examination of the smears for Amstel criteria (clue cells detection)\n* Current genital malignancies\n* Chemotherapy for any reason in last 6 months\n* Radiotherapy in the genitourinary system in the last 12 months\n* Use of antibiotics for any reason in the last 14 days\n* Use of intravaginal devices during the investigation or in the last 14 days\n* Pregnancy or currently attempting to conceive\n* Lactation\n* Use of other treatment for vaginal conditions during the course of the clinical investigation\n* Known allergies to ingredients of the product\n* Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation","FEMALE","18 Years",{"count":82,"type":83},200,"ESTIMATED","INTERVENTIONAL",[86],"NA","This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control.\n\nTreatment arm 1: Multi-Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi-Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.",[89],"Bacterial Vaginoses","2025-09-23",{"date":92,"type":93},"2025-09-29","ACTUAL",{"date":95,"type":93},"2021-06-11",{"date":97,"type":83},"2026-12-01",{"name":99,"class":6},"BioClin BV",1]