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Search / Trial NCT06453200

Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Recurrent Bacterial Vaginosis.

Launched by I.M. SECHENOV FIRST MOSCOW STATE MEDICAL UNIVERSITY · Jun 7, 2024

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Biofilms Bacterial Vaginosis Bovhyaluronidase Azoximer

ClinConnect Summary

This clinical trial is studying a new treatment called Bovhyaluronidase Azoximer to see if it can help destroy harmful bacteria in the urogenital tract of women who frequently experience bacterial vaginosis (BV). BV is a common condition that affects many women of reproductive age and is caused by an imbalance of bacteria in the vagina. This study aims to find out if this treatment can improve the effectiveness of current therapies and reduce the chances of BV coming back, ultimately enhancing the quality of life for women dealing with this issue.

To participate in the trial, women aged 18 to 45 with a confirmed diagnosis of bacterial vaginosis can sign up, provided they agree to the study terms. Participants will receive the study medication and will be monitored to see how well it works. It's important to note that women who are pregnant, breastfeeding, or have certain other health conditions will not be eligible for this study. By taking part, women may contribute to important research that could lead to better treatments for bacterial vaginosis in the future.

Gender

Female

Eligibility criteria

  • Inclusion Criteria:
  • availability of written informed consent to participate in the study
  • age (18-45 years)
  • established clinically (Amsel criteria) and laboratory (microscopic examination and PCR diagnosis of vaginal discharge) diagnosis of bacterial vaginosis
  • Exclusion Criteria:
  • patient refusal to further participate in the study
  • lack of patient adherence to treatment
  • pregnancy and lactation
  • the occurrence during the study of conditions and diseases that are included in the list of contraindications to the use of the drug being studied
  • presence of Candida albicans, diplococci, trichomanas), confirmed by microscopic examination and PCR diagnostics
  • presence of contraindications to the use of study drugs according to the instructions

About I.M. Sechenov First Moscow State Medical University

i.m. Sechenov First Moscow State Medical University is a prestigious institution dedicated to advancing medical education, research, and clinical practice. As a leading center for medical innovation in Russia, the university fosters a collaborative environment for scientific inquiry and the development of novel therapies. With a commitment to high-quality clinical trials, i.m. Sechenov aims to contribute significantly to the global biomedical landscape by evaluating new treatments and improving patient care through rigorous research methodologies and ethical standards.

Locations

Moscow, , Russian Federation

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

21 days, 6 month