Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age
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.
Timeline
- Start
- 2024-06-01
- Primary completion
- 2025-06-01
- Completion
- 2026-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bovhyaluronidase azoximer | Unknown | 3000 iu | Intravenous |
| Background | Metronidazole | Small molecule | 500 mg | Oral |