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    Summary
    EudraCT Number:2020-000758-81
    Sponsor's Protocol Code Number:Chlorhex-KKDS-2021
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-29
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-000758-81
    A.3Full title of the trial
    Chlorhexidine gluconate as treatment and prophylaxis of vulvovaginal Candidiasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial for Chlorhexidine as treatment for vulvovaginal candidiasis
    A.3.2Name or abbreviated title of the trial where available
    Chlorhex-KKDS-2021
    A.4.1Sponsor's protocol code numberChlorhex-KKDS-2021
    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 SponsorKarolinska Institutet
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportALF Swedish Research Council funding for clinical research in medicine
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDanderyd Hospital
    B.5.2Functional name of contact pointDiv of Obstetrics and Gynecology
    B.5.3 Address:
    B.5.3.1Street AddressDanderyd Hospital
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code18288
    B.5.3.4CountrySweden
    B.5.4Telephone number+46812355000
    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 Hibitane
    D.2.1.1.2Name of the Marketing Authorisation holderBioglan
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameHibitane
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Vaginal cream
    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 INNCHLORHEXIDINE GLUCONATE
    D.3.9.3Other descriptive nameHibitane vaginal cream
    D.3.9.4EV Substance CodeSUB01215MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.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 Fluconazol
    D.2.1.1.2Name of the Marketing Authorisation holderAccord
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameFluconazole
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Capsule
    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 INNFluconazole
    D.3.9.3Other descriptive nameFLUCONAZOLE
    D.3.9.4EV Substance CodeSUB07674MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Candida vulvovaginitis
    E.1.1.1Medical condition in easily understood language
    Vaginal yeast infection
    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 analyze if daily vaginal application of 8 ml of Hibitane® for one week and thereafter once a week for another 11 consecutive weeks is at least as effective as fluconazole 150 mg capsules every third day for the first three doses and thereafter 150 mg once a week for another 11 consecutive weeks regarding treatment- and prophylactic efficacy for recurrent vulvovaginal Candida albicans infection.
    E.2.2Secondary objectives of the trial
    1. To analyze adverse events
    2. To analyzed clinical symptoms and findings
    3. To study the effect on vaginal microbiome of lactobacillus before and after treatment and prophylaxis with CHG for RVVC.
    4. To evaluate the event of relapses during and after the prophylaxis treatment
    5. To investigate if CHG has toxic effect on the vaginal epithelial cells.
    6. To analyze vaginal biofilm formation before and after treatment and prophylaxis with CHG and FLZ for RVVC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 18-50 years of age
    • A history of > 2 candida infections the last year
    • Symptoms of acute vulvovaginal candida infection
    • Culture verified infection with Candida albicans
    • Adequate contraceptive method
    • Able to understand oral and written information in Swedish
    • The subject has given written consent to participate in the study
    E.4Principal exclusion criteria
    • Severe somatic or mental illness (including liver and kidney failure and cardiac disease)
    • Immunosuppressive medication
    • Pregnancy
    • Lactation
    • Other ongoing gynecological infections
    • Allergy to fluconazole or chlorhexidine gluconate
    • Citalopram or other medication that might have impact on the QT interval (terfenadin, cisaprid, astemizol, pimozid, kinidin, erythromycin, halofantrin, amiodaron)
    • Participation or recent participation (30 days) in a clinical study with an investigational product. Previous participation in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of women in each group that has negative vaginal cultures for Candida albicans 1 week after active treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 week (+2 days) after completed treatment. Control of AE, culture for Candida albicans and examination
    E.5.2Secondary end point(s)
    1. The proportion of women in each group that has negative vaginal cultures for Candida albicans at 3 months’ follow-up after prophylactic treatment and at 6 months’ follow-up after the observational phase of the study.
    2. Analysis of proportion of women with adverse events (AE) across treatment arms. The AEs will also be reported in descriptive terms and summarized for each treatment arm.
    3. Proportion of women with symptom score > 2. Each symptom of typical discharge, itching, dryness of the skin/mucosa, burning and pain will generate 1 point of a composite index (range 0-5).
    4. Proportion of women with examination score >2. Each finding of redness skin/mucosa, typical discharge, dry skin/mucosa, fissures skin/mucosa, visible candida hyphae in the microscope will generate 1 point of a composite index (range 0-5).
    5. Proportion of women with reduced vaginal lactobacilli content in vaginal smears measured by a semi-quantitative method as normal or reduced quantity.
    6. Proportion of women with relapse of Candida albicans infection between end of treatment and end of prophylactic treatment (1week post treatment to 3 months’ follow-up) and between 3- and 6 months’ follow-up after end of prophylactic treatment.
    7. Proportion of women with possible toxic effect on the vaginal epithelium, defined as disruption and/or inflammation of the epithelial lining, analyzed from vaginal biopsies before and after treatment and prophylaxis.
    8. Further analysis of mucosa inflammatory mechanism (histopathology and immunohistochemistry) and biofilm formation during and after treatment and prophylaxis, analyzed from vaginal biopsies. The methods for these in vitro exploratory analyses are not yet decided on.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 3 1 week (+2 days) after completed treatment. Control of AE, culture for Candida albicans and examination (no biopsies). 30 min.
    Visit 4 After 12 weeks (+ 1 week) from inclusion when prophylactic treatment is completed. Control of AE and relapses, culture for Candida albicans and examination, vaginal biopsies. 45 min.
    Visit 5 Follow-up 6 months (+ 1-2 weeks) from baseline/inclusion. Control of AE and relapses, culture for Candida albicans and examination (no biopsies). End of study. 30 min.
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    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: 60
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-10-29. Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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