[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551319":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":42,"locations":49,"responsibleParty":78,"collaborators":47,"id":80,"slug":47,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":47,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":47,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":52,"whyStopped":47,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"I.M. Sechenov First Moscow State Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","The experimental group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis.\n\nParticipants in the experimental group will be given the drug Bovgialuronidase azoximer and Metronidazole.\n\nBovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days",[13,14],"Drug: Longidaza","Drug: Metronidazole 500 mg",{"label":16,"type":17,"description":18,"interventionNames":19},"Control","ACTIVE_COMPARATOR","The control group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis.\n\nMetronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Longidaza","Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days",[9],[27],"Bovhyaluronidase azoximer",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Metronidazole 500 mg","Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days",[16,9],[33],"Metronidazol",[35,39],{"name":36,"affiliation":37,"role":38},"Leonid Spivak, MD,Prof.","I.M. Sechenov First Moscow State Medical University (Sechenov University)","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":37,"role":41},"Kseniya Rossolovskaya","STUDY_DIRECTOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Leonid Spivak, MD, Prof.","CONTACT","+7 (903) 749-05-97",null,"leonid.spivak@gmail.com",[50,67],{"facility":51,"status":52,"city":53,"state":47,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"LLC \"Family polyclinic No. 4\" Korolev","RECRUITING","Korolyov","141060","Russia",{"type":57,"coordinates":58},"Point",[59,60],37.82556,55.91417,{"lat":60,"lon":59},[63,64],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},{"name":40,"role":45,"phone":65,"phoneExt":47,"email":66},"+7 (980) 164-77-99","rossolovskaya_k_a@staff.sechenov.ru",{"facility":37,"status":52,"city":68,"state":47,"zip":69,"country":55,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Moscow","119991",{"type":57,"coordinates":71},[72,73],37.61781,55.75204,{"lat":73,"lon":72},[76,77],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},{"name":40,"role":45,"phone":65,"phoneExt":47,"email":66},{"type":79,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100551319",false,"NCT06458543","Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age","Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Reccurent Bacterial Vaginosis.","Inclusion Criteria:\n\n* The written informed consent of the patient to participate in the study;\n* Age (18 - 45 years old);\n* The established diagnosis of Bacterial vaginosis;\n* Absence of pregnancy and lactation.\n\nExclusion Criteria:\n\n* Refusal of the patient from further participation in the study;\n* Lack of patient adherence to treatment;\n* The occurrence of conditions and diseases related to the list of contraindications to the use of the studied drug during the study.\n* The presence of Neisseria gonorrhoeae, Trichomonas vaginalis, confirmed by laboratory;\n* The presence of contraindications to the use of the studied drug according to the instructions for the drug.","FEMALE","18 Years","45 Years",{"count":90,"type":91},100,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","The purpose of this clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are:\n\n* Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium\n* use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis.\n* use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis.\n\nParticipants in the experimental and control group will be:\n\n* Amsel criteria assessment\n* Colpotest-PH (vaginal acidity)\n* aminotest with 10% KOH solution (\"fish odor\")\n* microscopic examination of vaginal discharge\n* Bacteriologic culture of vaginal discharge\n* Polymerase chain reaction of epithelial cell scrapings from the vagina\n* electron microscopy of vaginal epithelial cell scrapings\n\nParticipants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole.\n\nParticipants in the control group: Metronidazole.\n\nResearchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival.",[97],"Bacterial Vaginosis",[97,99,100,101],"biofilms","bovhyaluronidase azoximer","treatment","2025-04-07",{"date":104,"type":105},"2025-04-09","ACTUAL",{"date":107,"type":105},"2024-06-01",{"date":109,"type":91},"2026-06-01",{"name":5,"class":6},2]