Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age

NCT06458543 | Recruiting Phase 4 DMC

• 1 other identifier: Longidaza IMSechenovMMA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bacterial Vaginosis

Keywords

Bacterial Vaginosis; biofilms; bovhyaluronidase azoximer; treatment

Outcome Measures

Primary Outcomes (1)

• 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"

  6 months after treatment

Secondary Outcomes (4)

• changes in biofilm structure according to electron microscopy data

  21 days after treatment

• decrease in the severity of characteristic complaints in female patients with BV

  21 days after treatment

• Decreased vaginal acidity

  21 days after treatment

• Normalization of the composition of the microflora of the urogenital tract

  21 days after treatment

Study Arms (2)

Experimental

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

Drug: Longidaza; Drug: Metronidazole 500 mg

Control

ACTIVE COMPARATOR

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

Interventions

Longidaza DRUG

Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days

Also known as: Bovhyaluronidase azoximer

Experimental

Metronidazole 500 mg DRUG

Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days

Also known as: Metronidazol

Control; Experimental

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The written informed consent of the patient to participate in the study;
• Age (18 - 45 years old);
• The established diagnosis of Bacterial vaginosis;
• Absence of pregnancy and lactation.

You may not qualify if:

• Refusal of the patient from further participation in the study;
• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (2)

LLC "Family polyclinic No. 4" Korolev

Korolyov, 141060, Russia

RECRUITING

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Longidaza; Metronidazole; Benchmarking

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms

Study Officials

• Leonid Spivak, MD,Prof.

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

• Kseniya Rossolovskaya

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  STUDY DIRECTOR

Central Study Contacts

Leonid Spivak, MD, Prof.

CONTACT

+7 (903) 749-05-97; leonid.spivak@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)