Bacterial VaginosisPhase 2/3LF-BV-09NCT01089348
A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis
A Phase 2/3 study testing Lactofiltrum + Metronidazole and Metronidazole in people with Bacterial Vaginosis, run by Avva Rus, JSC at 2 sites in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Lactofiltrum + Metronidazole and Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesRussia
- Study dates
- Jul 2010to Dec 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- bacterial vaginosis.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Kirov State Medical Academy
Kirov, Kirov Oblast, 610027
Sergey Dvoryanskiy, MD, DrSc, +7-8332-277211, dvorsa@mail.ru
Sergey Dvoryanskiy, MD, DrSc
- Recruiting
Kirov Regional Clinical Center of Perinatology
Kirov, Kirov Oblast, 610048
Nadezhda Yagovkina, MD, PhD, +7-8332-523639, nadezhda-yagovkina@yandex.ru
Nadezhda Yagovkina, MD, PhD
About this study
Official title: Phase II Multicentered Randomized Open-label Study of Effectiveness and Safety of Lactofiltrum in Women With Bacterial Vaginosis
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
- Being tested
- Lactofiltrum + Metronidazole, Metronidazole
- Keywords
- Vaginosis, Bacterial, Prebiotics, Lactofiltrum, Therapy
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactofiltrum + MetronidazoleDrug
Metronidazole 500 mg 1 tablet BID for 7 days + Lactofiltrum 2 tablets 3 times per day for 14 days per os
MetronidazoleDrug
Metronidazole 500 mg 1 tablet BID for 7 days per os
| Study group | Role | What they receive |
|---|---|---|
| Lactofiltrum | Experimental | Not described Receives: Drug: Lactofiltrum + Metronidazole |
| Control | Active comparator | Not described Receives: Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Days 0, 14 and 44 after start of intervention
Secondary outcomes (7)
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.
Measured: Days 0, 14 and 44 after start of intervention
Microscopy of vaginal discharge
Measured: Days 0, 14 and 44 after start of intervention
Microbiological examination of vaginal discharge
Measured: Days 0, 14 and 44 after start of intervention
pH-test of vaginal discharge
Measured: Days 0, 14 and 44 after start of intervention
Microbiological feces analysis
Measured: Days 0, 14 and 44 after start of intervention
Blood test
Measured: Days 0, 14 and 44 after start of intervention
Urine test
Measured: Days 0, 14 and 44 after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avva Rus, JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kirov State Medical Academy, Kirov Regional clinical Center of Perinatology
- Investigators
- Lyudmila Kobeleva, MD, PhD, Study director, Avva Rus, JSCSergey Dvoryanskiy, MD, DrSc, Principal investigator, Kirov State Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089348
- Sponsor's protocol ID
- 02/09-AVVA RUS
- Acronym
- LF-BV-09
- Status last verified
- Jul 2010
- First submitted
- 17 Mar 2010
- Last updated
- 21 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicentered Randomized Open-label Study of Effectiveness and Safety of Lactofiltrum in Women With Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT01089348
- Acronym / sponsor ID
- LF-BV-09 / 02/09-AVVA RUS
- Conditions
- Bacterial Vaginosis
- Keywords
- Vaginosis, Bacterial, Prebiotics, Lactofiltrum, Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Avva Rus, JSCIndustry (pharma, biotech, devices)
- Collaborators
- Kirov State Medical Academy, Kirov Regional clinical Center of Perinatology
- Study start
- Jul 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactofiltrum | Experimental | Drug: Lactofiltrum + Metronidazole |
| Control | Active comparator | Drug: Metronidazole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- bacterial vaginosis.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactofiltrum + MetronidazoleMetronidazole 500 mg 1 tablet BID for 7 days + Lactofiltrum 2 tablets 3 times per day for 14 days per os | Drug | Lactofiltrum |
| MetronidazoleMetronidazole 500 mg 1 tablet BID for 7 days per os | Drug | Control |
Primary outcome
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).
7 secondary outcomes
Gynaecological examination
Time frame: Days 0, 14 and 44 after start of intervention
Microscopy of vaginal discharge
Time frame: Days 0, 14 and 44 after start of intervention
Microbiological examination of vaginal discharge
Time frame: Days 0, 14 and 44 after start of intervention
pH-test of vaginal discharge
Time frame: Days 0, 14 and 44 after start of intervention
Microbiological feces analysis
Time frame: Days 0, 14 and 44 after start of intervention
Blood test
Time frame: Days 0, 14 and 44 after start of intervention
Urine test
Time frame: Days 0, 14 and 44 after start of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2010.
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyudmila Kobeleva, MD, PhD study director
Avva Rus, JSC
Sergey Dvoryanskiy, MD, DrSc principal investigator
Kirov State Medical Academy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lactofiltrum + Metronidazole and Metronidazole in people with Bacterial Vaginosis, run by Avva Rus, JSC at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lyudmila Kobeleva, MD, PhD (+7-495-9567559, kobeleva@leksir.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported complaints (time frame: Days 0, 14 and 44 after start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2010.