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Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age
Sponsor: I.M. Sechenov First Moscow State Medical University
Summary
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.
Official title: Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Reccurent Bacterial Vaginosis.
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-06-01
Completion Date
2026-06-01
Last Updated
2025-04-09
Healthy Volunteers
No
Conditions
Interventions
Longidaza
Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days
Metronidazole 500 mg
Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
Locations (2)
LLC "Family polyclinic No. 4" Korolev
Korolyov, Russia
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Russia