Bacterial VaginosisPhase 3NCT01160796
Lcr35® for Bacterial Vaginosis Prevention
A Phase 3 study testing Lcr35® in people with Bacterial Vaginosis, run by Laboratoires Lyocentre at 1 site in France.
Trial summary
This is a national, multi-centre, randomized, double-blind placebo-controlled, phase III superiority trial. The main objective of the trial is to assess the efficacy of Lcr35® by comparing the mean time before the onset of the first clinical recurrence confirmed by laboratory tests in patients with bacterial vaginosis… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Lcr35®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Apr 2012
- Phase
- Phase 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presenting with a symptomatic vaginosis characterised by the presence of the following 3 clinical criteria (among the 4 Amsel criteria) at V1:
- greyish uniform vaginal discharge,
- characteristic "rotten fish" smell caused by the spontaneous release of amine or during the potassium test or "sniff test",
- vaginal pH greater than 4.5.
- Patient with a Nugent score ≥ 7 (using the sample taken at V1).
- Patient clinically cured (none of the 3 Amsel criteria) after a 7-day course of Metronidazole (Flagyl®) Female.
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- Patient over 18 years of age.
- For women with childbearing potential:
- negative urine pregnancy test,
- use of a contraceptive method deemed effective by the Investigator (excluding spermicides).
- Patient having received information and voluntarily signed a written Informed Consent Form.
- Patient covered by a national insurance scheme.
Who cannot join
- Presence of a yeast infection that is bacterial (other than vaginosis) or viral in origin presumed or proven to be gynaecologically-linked, whether or not treated within the month preceding inclusion or present at the time of inclusion.
- Presence of an existing gynaecological infection that may interfere with the assessment of the trial treatment(fibroma, severe dysplasia of the cervix or in situ carcinoma, invasive carcinoma, intra-epithelial cervical neoplasia, squamous intra-epithelial lesions etc.)
- Antibiotics or antifungals taken by general route during the month preceding the screening visit, excluding treatment for an earlier episode of vaginosis.
- Use of probiotics in the month preceding the screening visit, excluding treatment for an earlier episode of vaginosis.
- Use of intravaginal antiseptics in the month preceding the screening visit, excluding treatment for an earlier episode of vaginosis.
- Use of prebiotics (acidifiers) during the two weeks preceding the screening visit.
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- Use of products containing topical oestrogens during the month preceding the screening visit.
- Allergy to one of the active ingredients or one of the excipients in the products.
- patient in post-menopausal time
- Patient unable to comply with the constraints of the Protocol.
- Breastfeeding patient.
- Patient with menstrual bleeds lasting more than 12 days a month.
- Patient having taken part in a clinical trial in the 3 months preceding inclusion in the present Protocol.
- Patient with a severe acute or chronic disease deemed by the Investigator to be incompatible with participation in the trial, or a serious infection that is life-threatening in the short term.
- Immuno-suppressed patient.
- Patient presenting with a previous illness which, according to the Investigator, is likely to interfere with the results of the trial or expose the patient to an additional risk.
- Patient linguistically or mentally unable to understand and sign the Informed Consent Form.
- Patient deprived of her liberty by order of the Courts or civil authorities or subject to a guardianship order.
- Patient likely not to comply with treatment.
- Patient unable to be contacted in the case of an emergency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Efficacy and Safety of Treatment With Total Freeze-dried Culture of Lactobacillus Casei Var. Rhamnosus (Lcr35®) Administered Intravaginally in the Prevention of Bacterial Vaginosis. Randomized, Phase III, Multi-centre, Double-blind, Placebo-controlled Superiority Trial
This is a national, multi-centre, randomized, double-blind placebo-controlled, phase III superiority trial.
The main objective of the trial is to assess the efficacy of Lcr35® by comparing the mean time before the onset of the first clinical recurrence confirmed by laboratory tests in patients with bacterial vaginosis treated with Lcr35® versus placebo.
Patients with bacterial vaginosis will be enroll by private gynecologists. Each patient will receive a treatment for the initial episode(Metronidazole)and a treatment to prevent the recurrence of bacterial vaginosis (Lcr35®).
- Conditions
- Bacterial Vaginosis
- Being tested
- placebo, Lcr35®
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
1x14-day course of treatment during 4 cycles
Lcr35®Drug
1x14-day course of treatment during 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Lcr35® | Experimental | Not described Receives: Drug: Lcr35® |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean time before the onset of first clinical recurrence confirmed by laboratory tests
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2011
- Study completionApr 2012
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Lyocentre
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160796
- Sponsor's protocol ID
- PREVA
- Status last verified
- Mar 2016
- First submitted
- 9 Jul 2010
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy and Safety of Treatment With Total Freeze-dried Culture of Lactobacillus Casei Var. Rhamnosus (Lcr35®) Administered Intravaginally in the Prevention of Bacterial Vaginosis. Randomized, Phase III, Multi-centre, Double-blind, Placebo-controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT01160796
- Acronym / sponsor ID
- PREVA
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Laboratoires LyocentreIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 12 Jul 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 national, multi-centre, randomized, double-blind placebo-controlled, phase III superiority trial.
The main objective of the trial is to assess the efficacy of Lcr35® by comparing the mean time before the onset of the first clinical recurrence confirmed by laboratory tests in patients with bacterial vaginosis treated with Lcr35® versus placebo.
Patients with bacterial vaginosis will be enroll by private gynecologists. Each patient will receive a treatment for the initial episode(Metronidazole)and a treatment to prevent the recurrence of bacterial vaginosis (Lcr35®).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lcr35® | Experimental | Drug: Lcr35® |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient presenting with a symptomatic vaginosis characterised by the presence of the following 3 clinical criteria (among the 4 Amsel criteria) at V1:
- Patient with a Nugent score ≥ 7 (using the sample taken at V1).
- Patient clinically cured (none of the 3 Amsel criteria) after a 7-day course of Metronidazole (Flagyl®) Female.
- Patient over 18 years of age.
- For women with childbearing potential:
Key exclusion criteria (20 listed)
- Presence of a yeast infection that is bacterial (other than vaginosis) or viral in origin presumed or proven to be gynaecologically-linked, whether or not treated within the month preceding inclusion or present at the time of inclusion.
- Presence of an existing gynaecological infection that may interfere with the assessment of the trial treatment(fibroma, severe dysplasia of the cervix or in situ carcinoma, invasive carcinoma, intra-epithelial cervical neoplasia, squamous intra-epithelial lesions etc.)
- Antibiotics or antifungals taken by general route during the month preceding the screening visit, excluding treatment for an earlier episode of vaginosis.
- Use of probiotics in the month preceding the screening visit, excluding treatment for an earlier episode of vaginosis.
- Use of intravaginal antiseptics in the month preceding the screening visit, excluding treatment for an earlier episode of vaginosis.
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 |
|---|---|---|
| placebo1x14-day course of treatment during 4 cycles | Drug | placebo |
| Lcr35®1x14-day course of treatment during 4 cycles | Drug | Lcr35® |
Primary outcome
mean time before the onset of first clinical recurrence confirmed by laboratory tests
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lcr35® in people with Bacterial Vaginosis, run by Laboratoires Lyocentre at 1 site in France.
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 12 inclusion and 20 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: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean time before the onset of first clinical recurrence confirmed by laboratory tests (time frame: 4 months). 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 25 Mar 2016.