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

NCT01089348 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2010-07-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Kirov State Medical Academy

    collaborator UNKNOWN

  • Kirov Regional clinical Center of Perinatology

    collaborator UNKNOWN

  • Avva Rus, JSC

    lead INDUSTRY

Principal Investigators

  • Lyudmila Kobeleva, MD, PhD · Avva Rus, JSC

  • Sergey Dvoryanskiy, MD, DrSc · Kirov State Medical Academy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-10-31
Completion
2010-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01089348 on ClinicalTrials.gov