Improving treatment for bacterial vaginosis in women of reproductive age

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

This study is testing a new treatment for bacterial vaginosis in women aged 18 to 45 to see if it can help them feel better and prevent the condition from coming back.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: I.M. Sechenov First Moscow State Medical University (Academic / other)
• Locations: 2 sites (Korolyov and 1 other locations)
• Trial ID: NCT06458543 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of bovgialuronidase azoximer in treating bacterial vaginosis and preventing its recurrence in women aged 18 to 45. The study aims to determine if this treatment can effectively destroy biofilms associated with G. vaginalis and enhance the efficacy of Metronidazole, the standard treatment. Participants will undergo various assessments, including microscopic examinations and bacteriologic cultures, to evaluate the treatment's impact on bacterial vaginosis. The goal is to improve the duration of relapse-free periods for patients suffering from this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 to 45 who have been diagnosed with bacterial vaginosis and are not pregnant or breastfeeding.

Not a fit: Patients with confirmed infections from Neisseria gonorrhoeae or Trichomonas vaginalis, or those with contraindications to the study drug, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the recurrence of bacterial vaginosis in women, improving their quality of life.

How similar studies have performed: While the approach of targeting biofilms in bacterial vaginosis is innovative, similar studies have shown promise in enhancing treatment efficacy, suggesting potential for success.

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.

Where this trial is running

Korolyov and 1 other locations

• LLC "Family polyclinic No. 4" Korolev — Korolyov, Russia (Recruiting)
• I.M. Sechenov First Moscow State Medical University (Sechenov University) — Moscow, Russia (Recruiting)

Study contacts

• Principal investigator: Leonid Spivak, MD,Prof. — I.M. Sechenov First Moscow State Medical University (Sechenov University)
• Study coordinator: Leonid Spivak, MD, Prof.

Conditions Bacterial Vaginosis; biofilms; bovhyaluronidase azoximer; treatment