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    Summary
    EudraCT Number:2013-002480-26
    Sponsor's Protocol Code Number:PRO_2013-02
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-002480-26
    A.3Full title of the trial
    Study of the efficacy and safety of treatment with total freeze-dried culture of Lcr Regenerans® administered intravaginally in the prevention of recurrent vulvovaginal candidiasis.
    International, randomized, phase III, multi-centre, 2-arm, parallel group, double-blind, placebo-controlled superiority trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the efficacy and safety of Lcr Regenerans®_GynoCans.
    A.3.2Name or abbreviated title of the trial where available
    Study of the efficacy and safety of Lcr Regenerans®_GynoCans.
    A.4.1Sponsor's protocol code numberPRO_2013-02
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/155/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBIOSE
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBIOSE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBIOSE
    B.5.2Functional name of contact pointClinical Monitoring Manager
    B.5.3 Address:
    B.5.3.1Street AddressRue des Frères Lumière
    B.5.3.2Town/ cityArpajon-sur-Cère
    B.5.3.3Post code15130
    B.5.3.4CountryFrance
    B.5.4Telephone number+330471468764
    B.5.5Fax number+330471635398
    B.5.6E-mailr.boissiere@biose.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGYNOPHILUS
    D.3.4Pharmaceutical form Vaginal capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLcr Regenerans
    D.3.10 Strength
    D.3.10.1Concentration unit billion CFU billion colony forming units
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number10E7
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboVaginal capsule, hard
    D.8.4Route of administration of the placeboVaginal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent vulvo-vaginal candidiasis
    E.1.1.1Medical condition in easily understood language
    Vaginal mycosis
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10047784
    E.1.2Term Vulvovaginal candidiasis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principle objective of this study is to assess the efficacy of Lcr Regenerans® by comparing the rate of clinical recurrence bacteriologically confirmed by mycological tests occurring in the treatment period or in the 5 months following discontinuation of the study treatment in patients with recurrent vulvovaginal candidiasis treated with Lcr Regenerans® according to a 1-cycle treatment regimen versus placebo.
    The efficacy of Lcr Regenerans® is compared to the efficacy of placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the efficacy and safety of Lcr Regenerans® by comparing therapeutic agent versus placebo using the same treatment regimen:
    1. Efficacy is assessed by comparing the time before the first clinical recurrence confirmed by mycological tests. The time before the first recurrence is calculated from visit V2.
    2. Efficacy is assessed by comparing the number of episodes of clinical recurrence confirmed by mycological tests per patient observed during the trial.
    3. The same criteria as those defined in the principle and secondary objectives (1 to 2), but including only episodes of recurrence related to Candida albicans
    4. Clinical safety of treatment
    5. The investigator’s opinion of overall safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Disease-related criteria:
    - Patients with recurrent vulvo-vginal candidiasis, defined by the existence of at least 4 episodes of VVC during the previous year including the episode which was the subject of the screening visit
    In addition to the current episode, at least one episode that occurred in the previous two years should also be documented by mycological examination.)
    - Patients with acute vulvovaginitis characterised by the presence of the following clinical criteria (i at V1: symptoms of pruritus, vulvovaginal signs such as erythema, vaginal discharge
    - Patients with a positive mycological examination at V1
    - Patients who are clinically cured at the end of Day 8 after treatment with MONAZOL Ovule (one ovule at bedtime) and so just after treatment with MONAZOL cream (treatment lasting 8 days).

    Relating to the population:
    - Women of childbearing age:
    Urinary pregnancy test negative
    Use of a contraceptive method considered effective by the investigator (except spermicides) throughout the test
    - Patient / legal representative speak and read the local language and having been informed of the study and has voluntarily signed an Informed Consent Form
    - Patient / legal representative affiliated with a social insurance scheme
    E.4Principal exclusion criteria
    Relating to the disease or gynaecological issues:
    - Presence of an infection, bacterial or viral, assumed or demonstrated to be gynaecological, whether treated or not in the month prior to inclusion or present at inclusion.
    - Presence of an existing gynaecological infection that may interfere with the assessment of the trial treatment (severe dysplasia of the cervix or in situ carcinoma, invasive carcinoma, intra-epithelial cervical neoplasia, squamous intra-epithelial lesions etc.)
    - Patients with a negative mycological examination at V1
    - No adequate documentation of earlier episodes to confirm the recurrent character of the VVC (4 episodes in one year, two of which documented a mycological examination in the past two years [and, in addition to the current episode, at least one episode occurred in the previous two years should also be documented in a mycological examination])
    Relating to treatment:
    - Taking systemic antifungals (particularly Fluconazole, see the list in 17.2) in the month prior to the screening visit to prevent recurrence, (treatment of an acute episode of VVC is not an exclusion criterion).
    - Use of probiotics (see the list in 17.2) in the 3 months preceding the screening visit.
    - Use of prebiotics (acidifying) (see the list in 17.2) in the 15 days preceding the screening visit.
    - Allergy to one of the active substances or one of the excipients in the products.
    Relating to the population:
    - Patients unable to comply with the constraints of the protocol.
    - Breastfeeding women.
    - Patients with bleeds for more than 12 days per month.
    - Patients who have taken part in a clinical study in the last month preceding inclusion in the present protocol.
    - Patients with severe disease, whether acute or chronic, deemed by the investigator to be incompatible with participation in the trial or a serious condition which is life-threatening in the short term.
    - Immunocompromised patients.
    - Patients with a previous illness which, according to the investigator, may interfere with the results of the study or expose the patient to an additional risk.
    - Patients linguistically (unable to speak or write French) or mentally unable to understand and sign the Informed Consent Form.
    - Patients deprived of their liberty by administrative or legal decision or under guardianship.
    - Patients who may not comply with treatment.
    - Patients unable to be contacted in the case of an emergency.
    E.5 End points
    E.5.1Primary end point(s)
    The principle objective of this study is to assess the efficacy of Lcr Regenerans® by comparing the rate of clinical recurrence bacteriologically confirmed by mycological tests occurring in the treatment period or in the 5 months following discontinuation of the study treatment in patients with recurrent vulvovaginal candidiasis treated with Lcr Regenerans® according to a 1-cycle treatment regimen versus placebo.
    The efficacy of Lcr Regenerans® is compared to the efficacy of placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Occurring in the treatment period or in the 5 months following discontinuation of the study.
    E.5.2Secondary end point(s)
    The secondary objectives are to assess the efficacy and safety of Lcr Regenerans® by comparing therapeutic agent versus placebo using the same treatment regimen:
    1. Efficacy is assessed by comparing the time before the first clinical recurrence confirmed by mycological tests. The time before the first recurrence is calculated from visit V2.
    2. Efficacy is assessed by comparing the number of episodes of clinical recurrence confirmed by mycological tests per patient observed during the trial.
    3. The same criteria as those defined in the principle and secondary objectives (1 to 2), but including only episodes of recurrence related to Candida albicans
    4. Clinical safety of treatment
    5. The investigator’s opinion of overall safety
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. The time before the first recurrence is calculated from visit V2.
    2, 3, 4, 5. During the trial.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of the follow-up period: 5 months following discontinuation of study treatment in the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 6
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 228
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 234
    F.4.2.2In the whole clinical trial 234
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-22
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