Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Reccurent Bacterial Vaginosis.

Longidaza IMSechenovMMA

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: * Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium * use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis. * use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis. Participants in the experimental and control group will be: * Amsel criteria assessment * Colpotest-PH (vaginal acidity) * aminotest with 10% KOH solution ("fish odor") * microscopic examination of vaginal discharge * Bacteriologic culture of vaginal discharge * Polymerase chain reaction of epithelial cell scrapings from the vagina * electron microscopy of vaginal epithelial cell scrapings Participants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole. Participants in the control group: Metronidazole. Researchers 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.

2024-06-01

2025-06-01

2026-06-01

Recruiting

Early phase I

100

Inclusion Criteria: * The written informed consent of the patient to participate in the study; * Age (18 - 45 years old); * The established diagnosis of Bacterial vaginosis; * Absence of pregnancy and lactation. Exclusion Criteria: * Refusal of the patient from further participation in the study; * Lack of patient adherence to treatment; * The occurrence of conditions and diseases related to the list of contraindications to the use of the studied drug during the study. * The presence of Candida spp., Neisseria gonorrhoeae, Trichomonas vaginalis, confirmed by laboratory; * The presence of contraindications to the use of the studied drug according to the instructions for the drug.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-06-13