Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age

April 7, 2025 updated by: I.M. Sechenov First Moscow State Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Bacterial vaginosis is characterized by a decrease in the number of lactobacilli and the dominance of opportunistic anaerobic flora (primarily G.vaginalis, to a lesser extent Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). Modern ideas of the pathogenesis of bacterial vaginosis consist in the formation of polymicrobial biofilms on the surface of the mucosa of the vaginal epithelium. Biofilms are a community of microorganisms of one or more species attached to the surface of a polymeric matrix. Biofilms are formed predominantly by G.vaginalis and to a lesser extent by other pathogens associated with bacterial vaginosis (Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). Biofilm-associated bacterial vaginosis is characterized by increased resistance to pathogenetic therapy, the ability to evade defense mechanisms and prolonged persistence in the vaginal environment. These features of pathogenesis cause a high rate of recurrences and chronic course of bacterial vaginosis.

Thus, it is relevant to study in vivo the role of drug action on biofilms to destroy them in order to increase the effectiveness of antibacterial therapy and reduce the frequency of recurrences of bacterial vaginosis.

The standard and approved by the Ministry of Health of the Russian Federation method of treatment of bacterial vaginosis is Metronidazole.

The aim of this clinical trial is to investigate the efficacy of combination therapy with metronidazole and azoximera bovgialuronidase in the treatment and duration of relapse-free course of bacterial vaginosis in women of reproductive age compared with metronidazole monotherapy.

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

Main group - patients with bacterial vaginosis receiving pathogenetic antibacterial therapy (Metronidazole) in combination with Bovgialuronidase azoximer.

Control group - patients with bacterial vaginosis receiving pathogenetic antibacterial therapy (Metronidazole) without Bovgialuronidase azoximer.

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental

The experimental group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis.

Participants in the experimental group will be given the drug Bovgialuronidase azoximer and Metronidazole.

Bovhyaluronidase 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
Drug: Longidaza
Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days
Other Names:
  • Bovhyaluronidase azoximer
Drug: Metronidazole 500 mg
Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
Other Names:
  • Metronidazol
Active Comparator: Control

The control group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis.

Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
Drug: Metronidazole 500 mg
Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
Other Names:
  • Metronidazol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in the number of relapses of bacterial vaginosis
Time Frame: 6 months after treatment

Evaluated by clinical data (using Amsel criteria) and laboratory (microscopic examination - identification of "key cells")

The Amsel criteria include 4 parameters, each of which is scored as one point:

  • gray/white/grayish-white vaginal discharge
  • Vaginal acidity pH greater than 4.5 (colpotest pH)
  • aminotest with 10% solution of potassium hydroxide KOH (appearance of "fishy", "rotten" odor)
  • Presence of "key cell" in microscopic examination of vaginal discharge

The presence of 3 or more of the 4 criteria speaks in favor of the diagnosis of "bacterial vaginosis" 2 and less points - absence of "bacterial vaginosis"
6 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in biofilm structure according to electron microscopy data
Time Frame: 21 days after treatment
Biofilms are a cooperation of microorganisms of one or more species that are incorporated into a polymeric matrix consisting of proteins, polysaccharides and nucleic acids. Electron microscopy allows to evaluate the structure of the biofilm, to distinguish between lactobacilli and anaerobes (G. vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). The destructive effect of azoximers bovgialuronidase on biofilms leads to disruption of biofilm structure: formation of holes in its structure, reduction of its size (volume), release of bacteria from the biofilm structure. Metronidazole has a bactericidal effect on G. vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc., which is expressed in the reduction of CFU/ml.
21 days after treatment
decrease in the severity of characteristic complaints in female patients with BV
Time Frame: 21 days after treatment

The main complaints that patients with bacterial vaginosis present with are: vaginal discharge and unpleasant odor of vaginal discharge.

The Amsel criteria are used to objectively assess these complaints

The Amsel criteria include 4 parameters, each of which is scored as one point:

  • gray/white/grayish-white vaginal discharge
  • Vaginal acidity pH greater than 4.5 (colpotest pH)
  • aminotest with 10% solution of potassium hydroxide KOH (appearance of "fishy", "rotten" odor)
  • Presence of "key cell" in microscopic examination of vaginal discharge

The presence of 3 or more of the 4 criteria speaks in favor of the diagnosis of "bacterial vaginosis" 2 and less points - absence of "bacterial vaginosis"

After treatment the patient is expected to have no characteristic complaints
21 days after treatment
Decreased vaginal acidity
Time Frame: 21 days after treatment

Normally, the acidity of the vagina is 4.5 or less (рН=4,5 оr less), meaning the vagina has an acidic environment.

The pH is measured with the Kolpotest-PH rapid test. After applying vaginal discharge to the indicator screen of the test strip, it is colored. The color obtained is compared with the indicator scale placed on the Colpotest-pH jar. If the pH is 4.5 or less, it is normal.

A pH result greater than 4.5 favors a diagnosis of bacterial vaginosis After treatment is expected to normalize vaginal acidity (pH = 4.5 or less)
21 days after treatment
Normalization of the composition of the microflora of the urogenital tract
Time Frame: 21 days after treatment

Normally, the vagina of women of reproductive age is dominated by Lactobacilli (80-100%). A decrease in lactobacilli or their absence leads to the dominance of opportunistic microorganisms (e.g., G.vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.), which causes the appearance of complaints characteristic of bacterial vaginosis (vaginal discharge, unpleasant odor of vaginal discharge, itching, burning).

Microbiome is assessed by polymer chain reaction (Femoflor-16), which allows not only qualitative but also quantitative assessment of the composition of the vaginal microbiome.

After treatment, the number of opportunistic anaerobes is expected to decrease and the number of lactobacilli is expected to be dominant
21 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Leonid Spivak, MD,Prof., I.M. Sechenov First Moscow State Medical University (Sechenov University)
  • Study Director: Kseniya Rossolovskaya, I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 9, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Longidaza IMSechenovMMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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