[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BioClin BV\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"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":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Bacterial Vaginoses","RECRUITING","2025-09-23",{"date":30,"type":31},"2025-09-29","ACTUAL",{"date":33,"type":31},"2021-06-11",{"date":35,"type":20},"2026-12-01",{"name":37,"class":38},"BioClin BV","INDUSTRY",""]