Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorI.M. Sechenov First Moscow State Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Longidaza
  • Metronidazole 500 mg

Treatment groups

100 Participants
are divided into 2 treatment groups