[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551319":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":42,"locations":49,"responsibleParty":79,"collaborators":47,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":47,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":47,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":52,"whyStopped":47,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"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",[50,68],{"facility":51,"status":52,"city":53,"state":47,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"LLC \"Family polyclinic No. 4\" Korolev","RECRUITING","Korolyov","141060","Russia","RU",{"type":58,"coordinates":59},"Point",[60,61],37.82556,55.91417,{"lat":61,"lon":60},[64,65],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},{"name":40,"role":45,"phone":66,"phoneExt":47,"email":67},"+7 (980) 164-77-99","rossolovskaya_k_a@staff.sechenov.ru",{"facility":37,"status":52,"city":69,"state":47,"zip":70,"country":55,"countryCode":56,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Moscow","119991",{"type":58,"coordinates":72},[73,74],37.61781,55.75204,{"lat":74,"lon":73},[77,78],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},{"name":40,"role":45,"phone":66,"phoneExt":47,"email":67},{"type":80,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100551319","phase-4-optimization-of-bacterial-vaginosis-treatment-in-women-of-reproductive-age-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":92,"type":93},100,"ESTIMATED","INTERVENTIONAL",[96],"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.",[99],"Bacterial Vaginosis",[99,101,102,103],"biofilms","bovhyaluronidase azoximer","treatment","2025-04-07",{"date":106,"type":107},"2025-04-09","ACTUAL",{"date":109,"type":107},"2024-06-01",{"date":111,"type":93},"2026-06-01",{"name":5,"class":6},2]