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

AVVA Pharmaceuticals

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Bacterial Vaginosis

Treatments

Drug: Lactofiltrum + Metronidazole

Drug: Metronidazole

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01089348

02/09-AVVA RUS

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

bacterial vaginosis.

Exclusion criteria

pregnancy and breast-feeding;
concomitant infection diseases;
systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolite agents by the time of inclusion;
application of intravaginal medicines during participation in the study;
severe diseases;
renal and hepatic failure;
application of pre-, probiotics and antibiotics 2 weeks before inclusion or during participation in the study;
participation in other clinical study 1 month before inclusion or during participation in the proposed study.