[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100424510":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":48,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},{"fullName":5,"class":6},"Karo Pharma AB","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active product","OTHER",null,[13],"Device: vaginal gel",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","vaginal gel","The placebo gel is a non-buffered gel. The active device is an acidic gel.",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Diana Zeneli, MD","CONTACT","0031614706949","diana.pasho@karopharma.com",[31],{"facility":32,"status":33,"city":34,"state":11,"zip":11,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Praxis Dr. Peters","RECRUITING","Hamburg","Germany","DE",{"type":38,"coordinates":39},"Point",[40,41],9.99302,53.55073,{"lat":41,"lon":40},[44],{"name":45,"role":27,"phone":11,"phoneExt":11,"email":11},"Klaus H Peters, Dr.med",{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[49],{"name":50,"class":6},"Avania","100424510","multi-gyn-actigel-plus-for-treatment-of-bacterial-vaginosis-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":61,"type":62},200,"ESTIMATED","INTERVENTIONAL",[65],"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.",[68],"Bacterial Vaginoses","2025-09-23",{"date":71,"type":72},"2025-09-29","ACTUAL",{"date":74,"type":72},"2021-06-11",{"date":76,"type":62},"2026-12-01",{"name":78,"class":6},"BioClin BV",1]