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Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age

NCT06458543 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-09

No results posted yet for this study

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.

Conditions

  • Bacterial Vaginosis

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

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Leonid Spivak, MD,Prof. · I.M. Sechenov First Moscow State Medical University (Sechenov University)

  • Kseniya Rossolovskaya · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-06-01
Completion
2026-06-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06458543 on ClinicalTrials.gov