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Search / Trial NCT06458543

Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age

Launched by I.M. SECHENOV FIRST MOSCOW STATE MEDICAL UNIVERSITY · Jun 10, 2024

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Bacterial Vaginosis Biofilms Bovhyaluronidase Azoximer Treatment

ClinConnect Summary

This clinical trial is studying a new treatment for bacterial vaginosis, a common vaginal infection, in women aged 18 to 45. Researchers want to see if a drug called bovgialuronidase azoximer can help eliminate the bacteria that cause this infection and improve the effectiveness of the standard treatment, Metronidazole. The trial will compare two groups: one group will receive both bovgialuronidase azoximer and Metronidazole, while the other group will only receive Metronidazole. The goal is to determine if the combination treatment helps reduce symptoms and prevents the infection from returning.

To participate, women must be diagnosed with bacterial vaginosis and not be pregnant or breastfeeding. They will undergo several tests, including checking for vaginal acidity and microscopic examination of vaginal discharge. Participants can expect to contribute to important research that may lead to better treatment options for bacterial vaginosis. The study is currently recruiting participants, and those interested should discuss it with their healthcare provider to see if they qualify.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.

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

Korolev, , Russian Federation

Patients applied

0 patients applied

Trial Officials

Leonid Spivak, MD,Prof.

Principal Investigator

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

Kseniya Rossolovskaya

Study Director

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported