drugset / Trial / NCT01089348

A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis

NCT01089348

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-07
Primary completion
2010-10
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactulose Other / unclassified 2 unknown Oral
Comparator Metronidazole Small molecule 500 mg Oral

Indications