A Phase 4 interventional study of Longidaza and Metronidazole 500 mg in Bacterial Vaginosis, sponsored by I.M. Sechenov First Moscow State Medical University. Recruiting at 2 sites in Russian Federation. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by I.M. Sechenov First Moscow State Medical University · Phase 4, Interventional, and Treatment
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:
Participants in the experimental and control group will be:
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.
Bacterial vaginosis is characterized by a decrease in the number of lactobacilli and the dominance of opportunistic anaerobic flora (primarily G.vaginalis, to a lesser extent Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). Modern ideas of the pathogenesis of bacterial vaginosis consist in the formation of polymicrobial biofilms on the surface of the mucosa of the vaginal epithelium. Biofilms are a community of microorganisms of one or more species attached to the surface of a polymeric matrix. Biofilms are formed predominantly by G.vaginalis and to a lesser extent by other pathogens associated with bacterial vaginosis (Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). Biofilm-associated bacterial vaginosis is characterized by increased resistance to pathogenetic therapy, the ability to evade defense mechanisms and prolonged persistence in the vaginal environment. These features of pathogenesis cause a high rate of recurrences and chronic course of bacterial vaginosis.
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:
Participants in the experimental and control group will be:
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.
240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 203 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 137 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Longidaza · Drug: Metronidazole 500 mg
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
Drug: Metronidazole 500 mg
Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days
Also known as: Bovhyaluronidase azoximer
Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
Also known as: Metronidazol
Reduction in the number of relapses of bacterial vaginosis
Evaluated by clinical data (using Amsel criteria) and laboratory (microscopic examination - identification of "key cells") The Amsel criteria include 4 parameters, each of which is scored as one point: * gray/white/grayish-white vaginal discharge * Vaginal acidity pH greater than 4.5 (colpotest pH) * aminotest with 10% solution of potassium hydroxide KOH (appearance of "fishy", "rotten" odor) * Presence of "key cell" in microscopic examination of vaginal discharge The presence of 3 or more of the 4 criteria speaks in favor of the diagnosis of "bacterial vaginosis" 2 and less points - absence of "bacterial vaginosis"
Time frame: 6 months after treatment
changes in biofilm structure according to electron microscopy data
Biofilms are a cooperation of microorganisms of one or more species that are incorporated into a polymeric matrix consisting of proteins, polysaccharides and nucleic acids. Electron microscopy allows to evaluate the structure of the biofilm, to distinguish between lactobacilli and anaerobes (G. vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). The destructive effect of azoximers bovgialuronidase on biofilms leads to disruption of biofilm structure: formation of holes in its structure, reduction of its size (volume), release of bacteria from the biofilm structure. Metronidazole has a bactericidal effect on G. vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc., which is expressed in the reduction of CFU/ml.
Time frame: 21 days after treatment
decrease in the severity of characteristic complaints in female patients with BV
The main complaints that patients with bacterial vaginosis present with are: vaginal discharge and unpleasant odor of vaginal discharge. The Amsel criteria are used to objectively assess these complaints The Amsel criteria include 4 parameters, each of which is scored as one point: * gray/white/grayish-white vaginal discharge * Vaginal acidity pH greater than 4.5 (colpotest pH) * aminotest with 10% solution of potassium hydroxide KOH (appearance of "fishy", "rotten" odor) * Presence of "key cell" in microscopic examination of vaginal discharge The presence of 3 or more of the 4 criteria speaks in favor of the diagnosis of "bacterial vaginosis" 2 and less points - absence of "bacterial vaginosis" After treatment the patient is expected to have no characteristic complaints
Time frame: 21 days after treatment
Decreased vaginal acidity
Normally, the acidity of the vagina is 4.5 or less (рН=4,5 оr less), meaning the vagina has an acidic environment. The pH is measured with the Kolpotest-PH rapid test. After applying vaginal discharge to the indicator screen of the test strip, it is colored. The color obtained is compared with the indicator scale placed on the Colpotest-pH jar. If the pH is 4.5 or less, it is normal. A pH result greater than 4.5 favors a diagnosis of bacterial vaginosis After treatment is expected to normalize vaginal acidity (pH = 4.5 or less)
Time frame: 21 days after treatment
Normalization of the composition of the microflora of the urogenital tract
Normally, the vagina of women of reproductive age is dominated by Lactobacilli (80-100%). A decrease in lactobacilli or their absence leads to the dominance of opportunistic microorganisms (e.g., G.vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.), which causes the appearance of complaints characteristic of bacterial vaginosis (vaginal discharge, unpleasant odor of vaginal discharge, itching, burning). Microbiome is assessed by polymer chain reaction (Femoflor-16), which allows not only qualitative but also quantitative assessment of the composition of the vaginal microbiome. After treatment, the number of opportunistic anaerobes is expected to decrease and the number of lactobacilli is expected to be dominant
Time frame: 21 days after treatment
Plan to share: No
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