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RECRUITING
NCT06458543
PHASE4

Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age

Sponsor: I.M. Sechenov First Moscow State Medical University

View on ClinicalTrials.gov

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

Interventions

DRUG

Longidaza

Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days

DRUG

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