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Clinical Trial Summary

Bacterial vaginosis (BV) occupies one of the leading places in the structure of the of gynecologic morbidity. This syndrome affects from 26 to 29% of women of reproductive age. Bacterial vaginosis is a non-inflammatory syndrome based on the replacement of normal lactoflora by opportunistic microorganisms. The modern concept of pathogenesis of bacterial vaginosis is the formation of biofilms, mainly Gardnerella vaginalis, on the surface of the vaginal epithelium. Associated with biofilms bacterial vaginosis is characterized by increased resistance to pathogenetic therapy, ability to evade protective mechanisms and prolonged persistence in the vaginal environment, which is manifested by an increase in the rate of recurrent and chronic course. In connection with the above described, it is relevant to study in vivo the role of drug action on biofilms in order to destroy them and, as a consequence, to increase the effectiveness of pathogenetic antibacterial therapy, reduce the frequency of BV recurrences and improve the quality of life of women. According to the local and international literature, there are various ways to affect biofilms, one of which is enzymatic destruction of the matrix. Bovgialuronidase azoximer was chosen as the study drug.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06453200
Study type Interventional
Source I.M. Sechenov First Moscow State Medical University
Contact Leonid Spivak, MD, PhD
Phone +79037490597
Email leonid.spivak@gmail.com
Status Recruiting
Phase Phase 4
Start date June 1, 2024
Completion date June 1, 2026

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