NCT01089348 (LF-BV-09) is a Phase 2/Phase 3 clinical trial of Lactofiltrum + Metronidazole in Bacterial Vaginosis, sponsored by Avva Rus, JSC.

Who is sponsoring NCT01089348?

NCT01089348 is sponsored by Avva Rus, JSC.

What drugs are being tested in NCT01089348?

Interventions in NCT01089348: Lactofiltrum + Metronidazole, Metronidazole.

What condition does NCT01089348 study?

NCT01089348 studies Bacterial Vaginosis.

Is NCT01089348 still recruiting?

NCT01089348 is currently status unknown. Last updated 20 July 2010.

Last reviewed 2010-07-20 · How we verify

NCT01089348: LF-BV-09

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 2/Phase 3 Last updated 20 July 2010

What this trial tests

Phase 2/Phase 3 trial testing Lactofiltrum + Metronidazole in Bacterial Vaginosis in 90 participants. Status unknown.

Timeline

1 July 2010

Primary endpoint
1 October 2010

1 December 2010

Quick facts

Lead sponsor	Avva Rus, JSC
Phase	Phase 2/Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	1 July 2010
Primary completion	1 October 2010
Estimated completion	1 December 2010
Sites	2 locations across Russia

Drugs / interventions tested

Lactofiltrum + Metronidazole — full drug profile →
Metronidazole (METRONIDAZOLE) — full drug profile →

Conditions studied

Bacterial Vaginosis — all drugs for Bacterial Vaginosis →

Sponsor

Avva Rus, JSC — full company profile →

Who can join

Adults 18 to 45, female only, with Bacterial Vaginosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Self-reported complaints
Time frame: Days 0, 14 and 44 after start of intervention
It's measured by seven ordinal (analog) scales (vaginal itch, vaginal burning, itch of external genitals, burning of external genitals, vaginal discharge, urination disorder,painful intercourse) with minimal value "0" (absent of the complaint-related discomfort) and maximal value "10" (maximal discomfort).

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Bacterial Vaginosis

Currently open trials in the same condition.

NCT07234786 — Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections · NA · recruiting
NCT06458543 — Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age · Phase 4 · recruiting
NCT06263465 — Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis · NA · recruiting
NCT05753813 — Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome · EARLY_PHASE1 · recruiting
NCT06616168 — Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens · Phase 1 · active not recruiting

Other Avva Rus, JSC trials

Trials by the same sponsor.

NCT06411314 — Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01089348 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Avva Rus, JSC
Last refreshed: 20 July 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01089348.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing