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    The EU Clinical Trials Register currently displays   41450   clinical trials with a EudraCT protocol, of which   6809   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2018-003095-12
    Sponsor's Protocol Code Number:LPP17630-C-018
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-17
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2018-003095-12
    A.3Full title of the trial
    An investigator-blinded, active controlled, randomized, two
    parallel group, multi-dose clinical trial to prove the non-inferior
    efficacy of Lactobacillus plantarum P 17630 100.000.000 CFU
    soft vaginal capsules (Proge Farm s.r.l.) versus miconazole
    nitrate 400 mg vaginal soft capsules in vaginal candidiasis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to demonstrate that the LJ
    LACTO - Lactobacillus plantarum P 17630
    100.000.000 CFU (Test) and DAKTARIN -
    miconazole nitrate 400 mg soft capsules resolv in equal way the problems linked to the vulvovaginal candidiasis.in patients
    A.4.1Sponsor's protocol code numberLPP17630-C-018
    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 SponsorPROGE FARM SRL
    B.1.3.4CountryItaly
    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 supportPROGE FARM
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationR&D Solutions srl
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Addressvia Luigi Perna, 51
    B.5.3.2Town/ cityRome
    B.5.3.3Post code00142
    B.5.3.4CountryItaly
    B.5.6E-mailinfo@rdsolutions.it
    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 Yes
    D.2.1.1.1Trade name LJ LACTO
    D.2.1.1.2Name of the Marketing Authorisation holderLJ PHARMA S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Vaginal capsule, soft
    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 plantarum P 17630
    D.3.9.3Other descriptive nameLACTOBACILLUS PLANTARUM P 17630
    D.3.9.4EV Substance CodeSUB21171
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number100.000.000 CFU
    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 DAKTARIN
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen – Cilag SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameDaktarin
    D.3.4Pharmaceutical form Capsule, soft
    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 INNMiconazole nitrate
    D.3.9.1CAS number 22832-87-7
    D.3.9.3Other descriptive nameMICONAZOLE NITRATE
    D.3.9.4EV Substance CodeSUB03285MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400mg
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients
    with clinically symptomatic vulvovaginal candidiasis.
    The following symptoms will be evaluated: pruritus,
    discharge, pain, dryness will be done using a daily
    VAS scale.
    E.1.1.1Medical condition in easily understood language
    Vulvovaginal candidiasis
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the non-inferiority efficacy of LJ
    LACTO - Lactobacillus plantarum P 17630
    100.000.000 CFU (Test) versus DAKTARIN -
    miconazole nitrate 400 mg soft capsules in patients
    with clinically symptomatic vulvovaginal candidiasis.
    The evaluation of the following symptoms: pruritus,
    discharge, pain, dryness will be done using a daily
    VAS scale.
    E.2.2Secondary objectives of the trial
    Evaluation of the interleukin (IL6) concentration in
    the vaginal secretion as parameter of vulvovaginal
    candidiasis.
    The safety and tolerability profile of Test product
    compared to Reference by assessing the
    occurrence of either topical or systemic AEs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pre-menopausal women of any race and
    between 18 to 45 years of age;
     Diagnosis of VVC based on the presence of the
    following four criteria: pruritus, discharge, pain,
    dryness;
     Negative results on the Bayer evaluating kit
    (Gyno-Canestest®);
     Negative pregnancy test
     Willing to refrain from using any vaginal product
    (e.g. spermicide, tampon, douche, diaphragm or
    condom), other than study product, on study
    Days 0-7;
     Willing to refrain from sexual intercourse on study
    Days 0-7;
     Able to understand the requirements of the
    clinical trial and to agree to return for the required
    follow-up visits;
     Willing to provide voluntary written informed
    consent and data protection declaration before
    any clinical trail related procedure is performed.
    E.4Principal exclusion criteria
    Menstruating when diagnosis of vulvovaginal
    candidiasis is determined at Baseline visit;
     Primary or secondary immunodeficiency;
     Severe liver disease;
     History of regional enteritis or ulcerative colitis;
     Current or past evidence of any vulvovaginitis
    other than bacterial vaginosis (e.g. candidiasis,
    Trichomonas vaginalis, Chlamydia trachomatis,
    Neisseria gonorrhoeae, Herpes simplex or
    human papilloma virus) in the previous 4 months;
     Subject will be under treatment during the study
    period for cervical intraepithelial neoplasia or
    cervical carcinoma;
     History of hypersensitivity to miconazole nitrate,
    Lactobacillus plantarum or any of the
    components of the formulation;
     Use within 2 weeks prior to baseline of topical or
    systemic antibiotics/antifungal;
     Use of spermicides, tampons, douches,
    diaphragms, condoms or other intra-vaginal
    product within 48 hours prior to dosing on study
    Day 0;
     Current participation or not yet completed period
    of at least 30 days since ending other
    investigational device or drug trial(s). Use of any
    experimental medicinal product within the 3
    months prior to screening.
     Unwillingness or inability to comply with the
    clinical trial procedures;
     Who are legally incapacitated;
     Who are legally detained in an official institute.
    E.5 End points
    E.5.1Primary end point(s)
    According to the literature (Van Leusden H.A.I.M., et al. Europ. J. Obstet. Gynec. Reprod. Biol., 1980:10/3:203-211), in which is stated that the positive results obtained with the miconazole treatment is more than 90%, it is reasonably accept a decrese of at maximum of the 20% as positive result.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Compare the number of patients stopped the treatment after 3 days either the VAS score values at baseline, at Day 3, at Day 6 and at Day 21
    E.5.2Secondary end point(s)
    The secondary endopoints, will be evaluated measured interleukin (IL6) in the vaginal secretion as parameter of vulvovaginal candidiasis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0, Day 3 and Day 6
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.4Double blind No
    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 concerned4
    E.8.5The trial involves multiple Member States No
    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 years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    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: 210
    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 state210
    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 Decision2019-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
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