Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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