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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-004563-37
    Sponsor's Protocol Code Number:IPR_GARDEFLORA_15-2
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-04-01
    Trial results View 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 number2015-004563-37
    A.3Full title of the trial
    Study of the efficacy and safety of treatment with completely lyophilised
    cultures of Lactobacillus crispatus - IP 174178 administered intravaginally
    in the treatment of bacterial vaginosis.
    Badanie skuteczności i bezpieczeństwa leczenia pełną liofilizowaną kulturą Lactobacillus crispatus – IP 174178 podawaną dopochwowo w leczeniu waginozy bakteryjnej, pod nazwą IPR_GARDEFLORA_15-2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the efficacy and safety of treatment administered intravaginally
    in the treatment of bacterial vaginosis.
    Badanie skuteczności i bezpieczeństwa leku podawanego dopochwowo w leczeniu
    waginozy bakteryjnej
    A.3.2Name or abbreviated title of the trial where available
    IPR_GARDEFLORA_15-2
    IPR_GARDEFLORA_15-2
    A.4.1Sponsor's protocol code numberIPR_GARDEFLORA_15-2
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLaboratoires IPRAD PHARMA
    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 supportLaboratoires IPRAD-PHARMA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationITEC Services
    B.5.2Functional name of contact pointNathalie CIENCIEWIEZ
    B.5.3 Address:
    B.5.3.1Street Address3 avenue Georges Clémenceau
    B.5.3.2Town/ cityCENON
    B.5.3.3Post code33150
    B.5.3.4CountryFrance
    B.5.4Telephone number330557778500
    B.5.5Fax number330557778501
    B.5.6E-mailnathalie.cienciewiez@itecservices.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 nameLactobacillus crispatus
    D.3.2Product code IP174 178
    D.3.4Pharmaceutical form Vaginal capsule
    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 INNLactobacillus Crispatus IP174178
    D.3.9.1CAS number D007778000
    D.3.9.2Current sponsor codeIP174178
    D.3.9.3Other descriptive nameLACTOBACILLUS
    D.3.9.4EV Substance CodeSUB43635
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number347
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name FLAGYL 250mg
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMetronidazole
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETRONIDAZOLE
    D.3.9.1CAS number 443-48-1
    D.3.9.3Other descriptive name2-methyl-5-nitro-1H-imidazole-1-ethanol
    D.3.9.4EV Substance CodeSUB08922MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number225 to 275
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    D.8.4Route of administration of the placeboVaginal use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bacterial vaginosis
    Waginoza bakteryjna
    E.1.1.1Medical condition in easily understood language
    Bacterial vaginosis
    Waginoza bakteryjna
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10046960
    E.1.2Term Vaginosis bacterial
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the efficacy of Lactobacillus crispatus – IP174178 in the normalisation of AMSEL criteria on D14 in the 2 arms.
    Ocena skuteczności Lactobacillus crispatus – IP174178 w normalizacji kryteriów AMSELA w 14-tym dniu badania (D14) w 2 ramionach.
    E.2.2Secondary objectives of the trial
    Assess the efficacy of Lactobacillus crispatus – IP174178 in the normalisation of AMSEL criteria on D28 in the 2 arms.
    Assess the efficacy of Lactobacillus crispatus – IP174178 in the normalisation of AMSEL criteria on D14 in the 2 arms, in 3
    subpopulations.
    Assess the efficacy of Lactobacillus crispatus – IP174178 in the normalisation of AMSEL criteria on D28 in the 2 arms, in 3
    subpopulations.
    Assessment of clinical response by the normalisation of AMSEL criteria AND bacteriological response (Nugent ≤ 3) on D14 and D28 globally and
    in three subpopulations.
    Assessment of bacteriological response (Nugent ≤ 3) on D14 and D28 globally and in three subpopulations.
    Evaluate the safety of Lactobacillus crispatus – IP174178 and compare it to standard treatment.
    • Ocena skuteczności Lactobacillus crispatus – IP174178 w normalizacji kryteriów AMSELA w D28 w 2 ramionach.
    • Ocena skuteczności Lactobacillus crispatus – IP174178 w normalizacji kryteriów AMSELA w D14 w 2 ramionach, w 3 podgrupach.
    • Ocena skuteczności Lactobacillus crispatus – IP174178 w normalizacji kryteriów AMSELA w D28 w 2 ramionach, w 3 podgrupach.
    • Ocena odpowiedzi klinicznej poprzez normalizację kryteriów AMSELA oraz odpowiedź bakteriologiczną (wynik w skali Nugenta ≤ 3) w D14 i D28 globalnie i w trzech podgrupach.
    • Ocena odpowiedzi bakteriologicznej (wynik w skali Nugenta ≤ 3) w D14 i D28 globalnie i w trzech podgrupach.
    • Ocena tolerancji Lactobacillus crispatus – IP174178 i porównanie jej z tolerancją leczenia referencyjnego.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Woman over 18 years old,
    • Patients with clinical symptoms suggestive of bacterial vaginosis, linked to an imbalance of vaginal flora, characterised by the presence of at least 3 of 4 of the following Amsel clinical criteria: uniform greyish vaginal discharge, characteristic odour of "rotten fish" caused by the spontaneous release of amine or during the potassium test or "sniff test", vaginal pH greater than 4.5, presence of "clue cells" (at least 20%) during the vaginal secretions direct exam
    • Patient with negative pregnancy test at V1,
    • Patient using a contraceptive method considered effective by the investigator (excluding spermicides),
    • Patient having received all the information on the study and having voluntarily given her written informed consent,
    • Patient registered with social security or other social protection.
    E.4Principal exclusion criteria
    • Presence of an existing gynaecological infection that may affect the evaluation of the trial treatment (severe dysplasia or cervical carcinoma in situ, invasive carcinoma, cervical intraepithelial neoplasia, squamous intraepithelial lesions etc.),
    • Patient having taken an antibiotic or antifungal treatment within 14 days prior to V1 (after administration by any route).
    • Patient unable to comply with the constraints of the protocol,
    • Patients having more than 12 days of menses per month,
    • Patient pregnant or breastfeeding,
    • Menopausal patient,
    • Patient with a known allergy to any of the active substances or to any of the excipients of the study products,
    • Patient with severe acute or chronic disease considered by the investigator as being incompatible with participation in this study, or with a serious infection that may endanger the life of the patient in the short term,
    • Immunosuppressed patient,
    • Patient with a previous illness that, according to the investigator, could compromise the results of the study or expose the patient to additional risk,
    • Patient with psychological or linguistic factors limiting the understanding and signature for the informed consent form,
    • Patient deprived of their liberty by court judgement or subject to guardianship,
    • Patient at risk of failing to follow the treatment (compliance problem),
    • Patient impossible to contact in an emergency.
    • Antibiotics or fungicides taken systemically during the month preceding the screening visit, excluding treatments for the bacterial vaginosis episode.
    • Use of local probiotics in the months preceding the screening visit.
    • Use of antiseptics in the months preceding the screening visit, excluding treatments for the bacterial vaginosis episode.
    • Use of prebiotics (acidifiers) during the two weeks preceding the screening visit.
    • Use of products containing topical oestrogen in the month before the screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with normalisation of AMSEL criteria at D14 in the 2 arms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Proportion of patients with normalisation of AMSEL criteria at D14 in the 2 arms.
    E.5.2Secondary end point(s)
    Proportion of patients with normalisation of AMSEL criteria at D28 in the 2 arms.
    Proportion of patients with normalisation of AMSEL criteria at D14 in the 2 arms in the 3 populations.
    Proportion of patients with normalisation of AMSEL criteria at D28 in the 2 arms in the 3 subpopulations.
    Assessment of clinical response by the normalisation of AMSEL criteria AND bacteriological response (Nugent ≤ 3) on D14 and D28 globally and in the three subpopulations.
    Assessment of bacteriological response (Nugent ≤ 3) on D14 and D28 globally and in the three subpopulations.
    Adverse events: Adverse events occurring during the study, as noted by the patient in her self-assessment log (diary) or gathered by the Investigator during visits, will be recorded in the Case Report Form (e-CRF).
    Evaluation of overall tolerance by the Investigator, after questioning the patient.
    This evaluation will be carried out using the following grading scheme:
    1 = Very good tolerance: no functional sign of discomfort and no objective signs on examination.
    2 = Good tolerance: a few functional signs of discomfort but minimum and short-lived in nature, not causing temporary cessation of
    applications. No objective signs on examination.
    3 = Moderate tolerance: marked or persistent functional signs of discomfort or objective signs on examination but not causing application
    of the trial product to cease temporarily.
    4 = Poor tolerance: functional and/or objective signs leading the patient to stop using the trial product.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints already indicated in the "secondary end point(s)" part (E.5.2).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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) Yes
    E.8.2.2Placebo No
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 530
    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 state320
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 530
    F.4.2.2In the whole clinical trial 530
    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
    Non applicable
    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 Decision2016-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-05-29
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