Actively Recruiting
Efficacy of Bovhyaluronidase Azoximer with Metronidazole for Treatment and Recurrence Prevention of Bacterial Vaginosis 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying bacterial vaginosis in women of reproductive age to evaluate the effectiveness of bovgialuronidase azoximer combined with Metronidazole. The study aims to determine if this combination can better destroy G. vaginalis biofilms on the vaginal lining, improve treatment results, and extend the time without recurrence compared to Metronidazole alone. Bacterial vaginosis involves an imbalance of vaginal bacteria with biofilm formation that makes treatment challenging and leads to frequent relapses. Participants are divided into two groups: one receives both bovgialuronidase azoximer vaginal suppositories every other day for 10 days plus a 7-day course of oral Metronidazole, while the control group receives only oral Metronidazole for 7 days. The study compares changes in biofilm structure, treatment effectiveness, and relapse-free duration between these groups. Assessments include vaginal acidity, microscopic and bacteriologic examination, PCR analysis, and electron microscopy of vaginal samples. Throughout the study, participants undergo multiple evaluations such as Amsel criteria assessment, aminotest for odor, and various laboratory tests to monitor infection and biofilm status. Researchers measure outcomes including relapse rates six months after treatment and changes in biofilm and vaginal flora three weeks post-treatment. The study tracks symptom severity and vaginal acidity during this period to understand treatment impact and safety.
CONDITIONS
Brief 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
- Female aged 18 to 45 years
- Established diagnosis of bacterial vaginosis
- Not pregnant or lactating
You will not qualify if you...
- Patient refusal to continue participation
- Poor adherence to treatment
- Conditions or diseases contraindicating the study drug
- Presence of Neisseria gonorrhoeae or Trichomonas vaginalis infections confirmed by lab tests
- Contraindications to the study drug according to its instructions or guidelines for use in this study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 10 days
Participants receive treatment for bacterial vaginosis with either Metronidazole alone or Metronidazole combined with Bovhyaluronidase azoximer.
1 baseline visit and 1 follow-up visit around 21 days after treatment
Duration - Up to 6 months after treatment
Participants are monitored to assess the reduction in relapse rate and evaluate biofilm changes, symptom improvement, vaginal acidity, and microflora normalization.
Visits at approximately 21 days and 6 months after treatment
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.
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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