Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age
NCT ID: NCT06458543
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2024-06-01
2026-06-01
Brief Summary
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* 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.
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Detailed Description
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Thus, it is relevant to study in vivo the role of drug action on biofilms to destroy them in order to increase the effectiveness of antibacterial therapy and reduce the frequency of recurrences of bacterial vaginosis.
The standard and approved by the Ministry of Health of the Russian Federation method of treatment of bacterial vaginosis is Metronidazole.
The aim of this clinical trial is to investigate the efficacy of combination therapy with metronidazole and azoximera bovgialuronidase in the treatment and duration of relapse-free course of bacterial vaginosis in women of reproductive age compared with metronidazole monotherapy.
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
Main group - patients with bacterial vaginosis receiving pathogenetic antibacterial therapy (Metronidazole) in combination with Bovgialuronidase azoximer.
Control group - patients with bacterial vaginosis receiving pathogenetic antibacterial therapy (Metronidazole) without Bovgialuronidase azoximer.
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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental
The experimental group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis.
Participants in the experimental group will be given the drug Bovgialuronidase azoximer and Metronidazole.
Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
Longidaza
Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days
Metronidazole 500 mg
Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
Control
The control group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis.
Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
Metronidazole 500 mg
Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
Interventions
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Longidaza
Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days
Metronidazole 500 mg
Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age (18 - 45 years old);
* The established diagnosis of Bacterial vaginosis;
* Absence of pregnancy and lactation.
Exclusion Criteria
* 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;
* The presence of contraindications to the use of the studied drug according to the instructions for the drug.
18 Years
45 Years
FEMALE
No
Sponsors
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I.M. Sechenov First Moscow State Medical University
OTHER
Responsible Party
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Principal Investigators
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Leonid Spivak, MD,Prof.
Role: PRINCIPAL_INVESTIGATOR
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Kseniya Rossolovskaya
Role: STUDY_DIRECTOR
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Locations
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LLC "Family polyclinic No. 4" Korolev
Korolyov, , Russia
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Longidaza IMSechenovMMA
Identifier Type: -
Identifier Source: org_study_id
NCT06453200
Identifier Type: -
Identifier Source: nct_alias
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