drugset / Trial / NCT01089348
A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis
Phase 2/3
Unknown
90 enrolled
Avva Rus, JSC
Kirov Regional clinical Center of Perinatology · collabKirov State Medical Academy · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lactulose | Other / unclassified | 2 unknown | Oral |
| Comparator | Metronidazole | Small molecule | 500 mg | Oral |