Candidiasis, VulvovaginalPhase 3GYNOCANSNCT02251093
Study of the Efficacy and Tolerance of Intra-vaginal Treatment With a Total Freeze-dried Culture of Lcr Regenerans® in the Prevention of Relapses of Recurrent Vulvovaginal Candidiasis
A Phase 3 study testing Lcr Regenerans in people with Candidiasis, Vulvovaginal, run by Probionov at 1 site in France.
Trial summary
The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus rhamnosus Lcr35® is a live bacterium administered with its culture medium. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Candidiasis, Vulvovaginal
- What is being tested?
- Lcr Regenerans
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Feb 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient suffering from recurrent VVC (RVVC) defined by the existence of at least 4 VVC episodes during the past year, including the one concerned by the screening visit In addition to the current episode, at least one episode occurring during the two previous years must also have been documented by mycological examination
- Patient suffering from acute vulvovaginitis characterised by the presence of the following clinical criteria at V1 (pruritus symptoms, vulvovaginal signs such as erythema, vaginal discharge)
- Patient with a positive mycological examination at V1
- Patient cured in clinical terms 8 days after treatment with MONAZOL 300 mg vaginal suppositories (one suppository at night before sleep, single administration) and followed by the application of MONAZOL 2 pourcent cream (8-day treatment)
- Woman of child-bearing age with a negative urine pregnancy test and using a means of contraception deemed effective by the investigator (excluding spermicides) throughout the trial
- Patient/Legal representative able to speak and read the local language, having been informed of the trial and having voluntarily signed an Informed Consent Form
- Patient/Legal representative registered with a social insurance scheme
Who cannot join
- Presence of a presumed or proven, gynaecologically-related bacterial or viral infection, whether treated or not during the month preceding the inclusion, or present at the time of inclusion.
- Presence of an existing gynaecological infection that could interfere with the assessment of the trial treatment (severe cervical dysplasia or carcinoma in situ, invasive carcinoma, intra-epithelial cervical neoplasia, squamous intra-epithelial lesions etc.)
- Patients with a negative mycological examination at V1
- Lack of adequately documented previous episodes to assert the recurrent nature of the VVC (4 episodes in one year, two of which documented by mycological examination over the past two years [thus, in addition to the current episode, at least one episode occurring during the two previous years must also have been documented by mycological examination])
- Antifungals taken by general route (in particular Fluconazole) during the month preceding the screening visit, in view of preventing recurrences (the treatment of an acute VVC episode is not an exclusion criterion).
- Use of probiotics in the month preceding the screening visit.
Show all 20Show fewer
- Use of prebiotics (acidifiers) during the two weeks preceding the screening visit.
- Allergy to one of the active ingredients or one of the excipients in the products.
- Patient unable to comply with the constraints of the Protocol.
- Breastfeeding patient.
- Patient with menstrual bleeding lasting more than 8 days a month.
- Post-menopausal women with last menstrual period at least 12 months prior to screening
- 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 (unable to speak or write the local language) 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 Tolerance of Intra-vaginal Treatment With a Total Freeze-dried Culture of Lcr Regenerans® in the Prevention of Relapses of Recurrent Vulvovaginal Candidiasis. International Phase III, Randomised, Multi-centre, Parallel-group, Two Arm, Double-blind Superiority Trial Versus Placebo.
The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus rhamnosus Lcr35® is a live bacterium administered with its culture medium.
It should be noted that Lcr Regenerans® is already marketed as a medical device (EC marking: 0499). It helps to regenerate the vaginal flora thanks to its physical and chemical effects (lowering the vaginal pH).
Read more
A number of in vitro and in vivo studies have demonstrated the ability of Lactobacillus rhamnosus Lcr35®:
- to establish itself in the vaginal epithelium, along with the durability of this establishment.
- and to inhibit the growth of pathogenic organisms responsible for causing bacterial vaginosis (Gardnerella vaginalis and Prevotella bivia) but also for mycoses (Candida albicans), by synthesising various microbicidal substances.
This research follows on from the Candiflore observational study in which 514 patients were monitored and which demonstrated a clearly positive result in favour of the use of vaginal Lcr Regenerans® for preventing recurrences of VVC.
The purpose of this new research is thus to demonstrate the efficacy of Lcr Regenerans®, in the prevention of vulvovaginal candidiasis recurrences in patients with a history of VVC with recurrent episodes, in view of obtaining a marketing authorisation.
Read the detailed description
Treatment of RVVC is difficult due to the multi-factor nature of recurrences and of the poorly understood local immune dysfunctions that may arise. The oral or topical antifungal maintenance treatment usually recommended is for a period of 6 months, though the VVC relapse rate is high, with 60 to 70% of women presenting with a recurrence within 2 months following termination of treatment. Moreover, antifungal agent-related adverse events are frequent and their long-term use can be conducive to the onset of bacterial vaginosis (BV).
The vaginal administration of probiotic strains (Lactobacillus) capable of regenerating the vaginal flora and of inhibiting the development of Candida albicans and/or its adhesion to the vaginal epithelium, would appear to be an interesting therapeutic alternative for preventing VVC recurrences.
The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus rhamnosus Lcr35® is a live bacterium administered with its culture medium.
It should be noted that Lcr Regenerans® is already marketed as a medical device (EC marking: 0499). It helps to regenerate the vaginal flora thanks to its physical and chemical effects (lowering the vaginal pH).
A number of in vitro and in vivo studies have demonstrated the ability of Lactobacillus rhamnosus Lcr35®:
- to establish itself in the vaginal epithelium, along with the durability of this establishment.
- and to inhibit the growth of pathogenic organisms responsible for causing bacterial vaginosis (Gardnerella vaginalis and Prevotella bivia) but also for mycoses (Candida albicans), by synthesising various microbicidal substances.
This research follows on from the Candiflore observational study in which 514 patients were monitored and which demonstrated a clearly positive result in favour of the use of vaginal Lcr Regenerans® for preventing recurrences of VVC.
The purpose of this new research is thus to demonstrate the efficacy of Lcr Regenerans®, in the prevention of vulvovaginal candidiasis recurrences in patients with a history of VVC with recurrent episodes, in view of obtaining a marketing authorisation.
- Conditions
- Candidiasis, Vulvovaginal
- Being tested
- Lcr Regenerans, Placebo
- Keywords
- mycosis, vulvovaginal candidiasis, lcr35, Lcr Regenerans®
- Medical subject headings
- Candidiasis, Vulvovaginal, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lcr RegeneransDrug
Also called GYNOPHILUS
Dosage: 1 vaginal capsule per day Route of administration: intravaginal Treatment duration: One 21-day cycle
PlaceboDrug
Dosage: 1 vaginal capsule per day Route of administration: intravaginal Treatment duration: One 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Lcr Regenerans | Experimental | Not described Receives: Drug: Lcr Regenerans |
| 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.
Recurrence confirmed by a mycological test, occurring during the treatment period, or within 5 months of trial treatment termination
The main outcome measure chosen for this trial is the rate of clinical recurrence confirmed by a mycological test, occurring during the treatment period, or within 5 months of trial treatment termination (fraction of patients presenting with at least one recurrence during the treatment period or during the 5-month monitoring period).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, VulvovaginalStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probionov
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe JUDLIN, Principal investigator, Maternité Régionale Universitaire de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251093
- Sponsor's protocol ID
- PRO_2013 - 02
- Other IDs
- 2013-002480-26
- Acronym
- GYNOCANS
- Status last verified
- Mar 2016
- First submitted
- 24 Sep 2014
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 Tolerance of Intra-vaginal Treatment With a Total Freeze-dried Culture of Lcr Regenerans® in the Prevention of Relapses of Recurrent Vulvovaginal Candidiasis. International Phase III, Randomised, Multi-centre, Parallel-group, Two Arm, Double-blind Superiority Trial Versus Placebo.
- ClinicalTrials.gov ID
- NCT02251093
- Acronym / sponsor ID
- GYNOCANS / PRO_2013 - 02
- Conditions
- Candidiasis, Vulvovaginal
- Keywords
- mycosis, vulvovaginal candidiasis, lcr35, Lcr Regenerans®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- ProbionovIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Feb 2016 (actual)
- First posted
- 26 Sep 2014 (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.
The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus rhamnosus Lcr35® is a live bacterium administered with its culture medium.
It should be noted that Lcr Regenerans® is already marketed as a medical device (EC marking: 0499). It helps to regenerate the vaginal flora thanks to its physical and chemical effects (lowering the vaginal pH).
A number of in vitro and in vivo studies have demonstrated the ability of Lactobacillus rhamnosus Lcr35®:
- to establish itself in the vaginal epithelium, along with the durability of this establishment.
- and to inhibit the growth of pathogenic organisms responsible for causing bacterial vaginosis (Gardnerella vaginalis and Prevotella bivia) but also for mycoses (Candida albicans), by synthesising various microbicidal substances.
This research follows on from the Candiflore observational study in which 514 patients were monitored and which demonstrated a clearly positive result in favour of the use of vaginal Lcr Regenerans® for preventing recurrences of VVC.
The purpose of this new research is thus to demonstrate the efficacy of Lcr Regenerans®, in the prevention of vulvovaginal candidiasis recurrences in patients with a history of VVC with recurrent episodes, in view of obtaining a marketing authorisation.
Detailed description
Treatment of RVVC is difficult due to the multi-factor nature of recurrences and of the poorly understood local immune dysfunctions that may arise. The oral or topical antifungal maintenance treatment usually recommended is for a period of 6 months, though the VVC relapse rate is high, with 60 to 70% of women presenting with a recurrence within 2 months following termination of treatment. Moreover, antifungal agent-related adverse events are frequent and their long-term use can be conducive to the onset of bacterial vaginosis (BV).
The vaginal administration of probiotic strains (Lactobacillus) capable of regenerating the vaginal flora and of inhibiting the development of Candida albicans and/or its adhesion to the vaginal epithelium, would appear to be an interesting therapeutic alternative for preventing VVC recurrences.
The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus rhamnosus Lcr35® is a live bacterium administered with its culture medium.
It should be noted that Lcr Regenerans® is already marketed as a medical device (EC marking: 0499). It helps to regenerate the vaginal flora thanks to its physical and chemical effects (lowering the vaginal pH).
A number of in vitro and in vivo studies have demonstrated the ability of Lactobacillus rhamnosus Lcr35®:
- to establish itself in the vaginal epithelium, along with the durability of this establishment.
- and to inhibit the growth of pathogenic organisms responsible for causing bacterial vaginosis (Gardnerella vaginalis and Prevotella bivia) but also for mycoses (Candida albicans), by synthesising various microbicidal substances.
This research follows on from the Candiflore observational study in which 514 patients were monitored and which demonstrated a clearly positive result in favour of the use of vaginal Lcr Regenerans® for preventing recurrences of VVC.
The purpose of this new research is thus to demonstrate the efficacy of Lcr Regenerans®, in the prevention of vulvovaginal candidiasis recurrences in patients with a history of VVC with recurrent episodes, in view of obtaining a marketing authorisation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lcr Regenerans | Experimental | Drug: Lcr Regenerans |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patient suffering from recurrent VVC (RVVC) defined by the existence of at least 4 VVC episodes during the past year, including the one concerned by the screening visit In addition to the current episode, at least one episode occurring during the two previous years must also have been documented by mycological examination
- Patient suffering from acute vulvovaginitis characterised by the presence of the following clinical criteria at V1 (pruritus symptoms, vulvovaginal signs such as erythema, vaginal discharge)
- Patient with a positive mycological examination at V1
- Patient cured in clinical terms 8 days after treatment with MONAZOL 300 mg vaginal suppositories (one suppository at night before sleep, single administration) and followed by the application of MONAZOL 2 pourcent cream (8-day treatment)
- Woman of child-bearing age with a negative urine pregnancy test and using a means of contraception deemed effective by the investigator (excluding spermicides) throughout the trial
Key exclusion criteria (20 listed)
- Presence of a presumed or proven, gynaecologically-related bacterial or viral infection, whether treated or not during the month preceding the inclusion, or present at the time of inclusion.
- Presence of an existing gynaecological infection that could interfere with the assessment of the trial treatment (severe cervical dysplasia or carcinoma in situ, invasive carcinoma, intra-epithelial cervical neoplasia, squamous intra-epithelial lesions etc.)
- Patients with a negative mycological examination at V1
- Lack of adequately documented previous episodes to assert the recurrent nature of the VVC (4 episodes in one year, two of which documented by mycological examination over the past two years [thus, in addition to the current episode, at least one episode occurring during the two previous years must also have been documented by mycological examination])
- Antifungals taken by general route (in particular Fluconazole) during the month preceding the screening visit, in view of preventing recurrences (the treatment of an acute VVC episode is not an exclusion criterion).
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 |
|---|---|---|
| Lcr RegeneransAlso: GYNOPHILUSDosage: 1 vaginal capsule per day Route of administration: intravaginal Treatment duration: One 21-day cycle | Drug | Lcr Regenerans |
| PlaceboDosage: 1 vaginal capsule per day Route of administration: intravaginal Treatment duration: One 21-day cycle | Drug | Placebo |
Primary outcome
Recurrence confirmed by a mycological test, occurring during the treatment period, or within 5 months of trial treatment termination
Time frame: 5 months
The main outcome measure chosen for this trial is the rate of clinical recurrence confirmed by a mycological test, occurring during the treatment period, or within 5 months of trial treatment termination (fraction of patients presenting with at least one recurrence during the treatment period or during the 5-month monitoring period).
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.
Related trials for Candidiasis, Vulvovaginal
Recruiting
Multi-Gyn FemiTotal for the Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis
Bacterial Vaginosis, Vaginal Candidiasis
RecruitingObservational study
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Active, not recruitingObservational study
Comparative Performance of a Vaginal Yeast Test
Vulvovaginal Candidiasis
Active, not recruitingObservational study
DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
Vulvovaginal Candidiasis
Not yet recruiting
Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment
Genitourinary Syndrome of Menopause (GSM), Bacterial Vaginosis
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.
Philippe JUDLIN principal investigator
Maternité Régionale Universitaire de Nancy
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 Lcr Regenerans in people with Candidiasis, Vulvovaginal, run by Probionov 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 7 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?
Recurrence confirmed by a mycological test, occurring during the treatment period, or within 5 months of trial treatment termination (time frame: 5 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.