Actively Recruiting

Phase 4
Age: 18Years - 45Years
FEMALE
NCT06458543

Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age

Led by I.M. Sechenov First Moscow State Medical University · Updated on 2025-04-09

100

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent to participate in the study
  • Age between 18 and 45 years old
  • Established diagnosis of bacterial vaginosis
  • Not pregnant and not breastfeeding
Not Eligible

You will not qualify if you...

  • Patient refusal to continue participation
  • Poor adherence to treatment
  • Development of conditions contraindicating use of the study drug
  • Presence of Neisseria gonorrhoeae or Trichomonas vaginalis infections
  • Contraindications to the study drug as per its instructions

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

LLC "Family polyclinic No. 4" Korolev

Korolyov, Russia, 141060

Actively Recruiting

2

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia, 119991

Actively Recruiting

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Research Team

L

Leonid Spivak, MD, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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