NCT01089348

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Avva Rus, JSC · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	Lactofiltrum + Metronidazole	Metronidazole 500 mg 1 tablet BID for 7 days + Lactofiltrum 2 tablets 3 times per day for 14 days per os
DRUG	Metronidazole	Metronidazole 500 mg 1 tablet BID for 7 days per os

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-10-01
• Completion: 2010-12-01
• First posted: 2010-03-18
• Last updated: 2010-07-21

Locations

2 sites across 1 country: Russia