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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01089348
Other study ID # 02/09-AVVA RUS
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received March 17, 2010
Last updated July 20, 2010
Start date July 2010
Est. completion date December 2010

Study information

Verified date July 2010
Source Avva Rus, JSC
Contact Lyudmila Kobeleva, MD, PhD
Phone +7-495-9567559
Email kobeleva@leksir.ru
Is FDA regulated No
Health authority Russia: Local Ethics Committee of Kirov State Medical AcademyRussia: Local Ethics Committee of Kirov Regional clinical Center of PerinatologyRussia: Ethics CommitteeRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Federal Service on surveillance in Healthcare and Social development
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Lactofiltrum + Metronidazole
Metronidazole 500 mg 1 tablet BID for 7 days + Lactofiltrum 2 tablets 3 times per day for 14 days per os
Metronidazole
Metronidazole 500 mg 1 tablet BID for 7 days per os

Locations

Country Name City State
Russian Federation Kirov Regional Clinical Center of Perinatology Kirov Kirov oblast
Russian Federation Kirov State Medical Academy Kirov Kirov oblast

Sponsors (3)

Lead Sponsor Collaborator
Avva Rus, JSC Kirov Regional clinical Center of Perinatology, Kirov State Medical Academy

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported complaints 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). Days 0, 14 and 44 after start of intervention No
Secondary Gynaecological examination It's represented by three ordinal scales with minimal value "0" ("not at all") and maximal value "3" ("severe"). They are measured by physician. Days 0, 14 and 44 after start of intervention No
Secondary Microscopy of vaginal discharge Days 0, 14 and 44 after start of intervention No
Secondary Microbiological examination of vaginal discharge Days 0, 14 and 44 after start of intervention No
Secondary pH-test of vaginal discharge Days 0, 14 and 44 after start of intervention No
Secondary Microbiological feces analysis Days 0, 14 and 44 after start of intervention No
Secondary Blood test Days 0, 14 and 44 after start of intervention Yes
Secondary Urine test Days 0, 14 and 44 after start of intervention Yes
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