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A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis — LF-BV-09  

Bacterial Vaginosis Clinical Trial

Official title:
Phase II Multicentered Randomized Open-label Study of Effectiveness and Safety of Lactofiltrum in Women With Bacterial Vaginosis

Clinical Trial Summary

This is a phase II multicenter randomized open-label clinical study that will determine whether treatment with Lactofiltrum (orally administered tablets) in combination with antibiotic therapy (metronidazole) is effective in women with bacterial vaginosis. Lactofiltrum is a composite drug that includes enterosorbent lignin and prebiotic Lactulose. It's supposed that supplement of Lactofiltrum to a standard therapy of bacterial vaginosis (metronidazole administered orally) improves women's general state, leads to better recovery of clinical, microbiological, biochemical and histological features of the disease.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01089348
Study type Interventional
Source Avva Rus, JSC
Contact Lyudmila Kobeleva, MD, PhD
Phone +7-495-9567559
Email kobeleva@leksir.ru
Status Recruiting
Phase Phase 2/Phase 3
Start date July 2010
Completion date December 2010
View Details
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