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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Moscow, , Russian Federation
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
21 days, 6 month