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    Summary
    EudraCT Number:2019-002325-30
    Sponsor's Protocol Code Number:VMP-03/2018
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-24
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-002325-30
    A.3Full title of the trial
    Prospective, open-label, monocenter, trial to investigate the efficacy and tolerability of Vagisan® a lactic acid containing vaginal suppository, in a panel of post-menopausal women suffering from vulvo vaginal atrophy (VVA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective, open-label, monocenter, trial to investigate the efficacy and tolerability of Vagisan® a lactic acid containing vaginal suppository, in a panel of post-menopausal women suffering from vulvo vaginal atrophy (VVA)
    A.4.1Sponsor's protocol code numberVMP-03/2018
    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 SponsorDr. August Wolff GmbH & Co. KG Arzneimittel
    B.1.3.4CountryGermany
    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 supportDr. August Wolff GmbH & Co. KG Arzneimittel
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. August Wolff GmbH & Co. KG Arzneimittel
    B.5.2Functional name of contact pointClarissa Masur
    B.5.3 Address:
    B.5.3.1Street AddressSudbrackstr. 56
    B.5.3.2Town/ cityBielefeld
    B.5.3.3Post code33611
    B.5.3.4CountryGermany
    B.5.4Telephone number490521 521 8808319
    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 Vagisan
    D.2.1.1.2Name of the Marketing Authorisation holderDr. August Wolff GmbH & Co.KG Arzneimittel
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameVagisan
    D.3.4Pharmaceutical form Pessary
    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 INN(S)-Milchsäure and Natrium-(S)-lactat-Lösung (entspr. 40 mg Milchsäure).
    D.3.9.3Other descriptive nameLACTIC ACID PH. EUR.
    D.3.9.4EV Substance CodeSUB171185
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number190
    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
    vulvovaginal atrophy
    E.1.1.1Medical condition in easily understood language
    vaginale atrophy and associated symptoms (dryness, itching, burning, pain)
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10047782
    E.1.2Term Vulvovaginal atrophy
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this trial is to investigate the changes in the Vaginal Maturation Index (VMI) during the course of the trial
    E.2.2Secondary objectives of the trial
    •Evaluation of the Day-to-Day impact of Vaginal Aging Questionnaire (DIVA)

    •Vaginal Health Index (investigator's assessment of vaginal findings: fluid secretion, moisture, overall elasticity, pH, epithelia mucosa).
    •Vaginal status of Lactobacillus flora (normal range, increased, decreased).
    •Subjective symptoms of atrophy (dryness, itching, burning and pain unrelated to sexual intercourse), and dyspareunia

    Safety Assessments:
    •Global judgement of tolerability by the Investigator
    •Global judgement of tolerability by the patient
    •Premature trial termination due to adverse reactions
    •Safety parameters (adverse events, concomitant medication, blood pressure and pulse rate)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Post-menopausal women with the subjective symptomatology of “vulvovaginal and atrophy" with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a VMI of < 35 at Screening
    •Last menstruation more than 12 months before Visit 1 OR bilateral oophorectomy with or without hysterectomy more than 3 months before Visit 1.
    •Healthy women as assessed by the medical history or women with well treated chronic disorders (e.g. hypertension, hypercholesterinemia, diabetes, depression etc.).
    •Signed written informed consent before participation in the trial.
    •Willingness to actively participate in the trial and to come to the scheduled visits.
    E.4Principal exclusion criteria
    •Known hypersensitivity against any of the ingredients of the test products.
    •Systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of SERMs (inter alia anti-estrogens) within 3 months before Visit 1 and / or during the conduct of this trial.
    •Local hormonal therapy (vagina/vulva) within 3 months before Visit 1 (also when used for the brightening/pretreatment of cytological smears).
    •Non-healed vaginal surgery.
    •Vaginal inflammation which is not caused by "vulvovaginal atrophy".
    •Use of moisturizers (vagina/vulva) within 14 day before Visit 1 and during the conduct of this trial.
    •Any use of products (including lubricants), other than the test product, applied intravaginally or on the vulva during the conduct of this trial.
    •Systemic corticosteroids within 14 days before Visit 1 and during the conduct of this trial (corticoid asthma sprays are allowed).
    •Chronic disease of the genital area, e.g. lichen sclerosus.
    •Patients with known infectious diseases (e.g. hepatitis or HIV infection).
    •Clinically diagnosed vaginal infection (acute or during the conduct of the trial).
    •Use of antibiotics or antimycotics within 14 days before Visit 1 and / or during this trial.
    •Acute drug- or alcohol abuse.
    •Patients with poor compliance and / or poor willingness to cooperate.
    •Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing.
    •Patients, who are inmates of psychiatric wards, prisons or state institutions.
    •Participation in a clinical trial with investigational medicinal products within the last 30 days prior to the start of this study and / or during this trial.
    •Patients underlying any other restrictions due to the participation in other tests / test institutes.
    •Employees of the study sites who are directly involved in this trial or employees of the Sponsor’s company.
    •If in the opinion of the investigator the patient should not participate in the study for any reason
    E.5 End points
    E.5.1Primary end point(s)
    The comparison of the mean VMI between Day 1 and Day 43
    E.5.1.1Timepoint(s) of evaluation of this end point
    D1 and Day 43 (after 6 weeks treatment)
    E.5.2Secondary end point(s)
    •Comparisons of each assessment time (Day 1 to 8, Day 8 to 43, and Day 1 to 43) for:
    oSum scores of each of the four categories of the DIVA questionnaire (daily activities, emotional well-being, sexual functioning, self-concept and body image)
    oDIVA total score including all four categories
    oVMI (except Day 1 to 43)
    oVHI for each parameter, and as sum score over objective assessment of vaginal findings
    oSeverity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) at each assessment time and as sum score over subjective assessment of vaginal findings at each assessment time
    oSeverity scoring for dyspareunia (if sexually active)

    •Vaginal status of Lactobacillus Flora

    Safety assessments:
    •Global judgment of the tolerability by the Investigator on Day 43
    •Global judgment of the tolerability by the patient on Day 43
    •Premature trial termination due to adverse reactions
    •Safety parameters (adverse events, concomitant medication, blood pressure and pulse rate)
    E.5.2.1Timepoint(s) of evaluation of this end point
    timepoints of evaluation for DIVA questionnaire, VHI, VMI subjective symptoms, severity of dyspareunia and vaginal status of Lactobacillus are Day 1, Day 8 and Day 43

    Timepoint for evaluation of tolerability by patient and investigator is Day 43.

    timepoints for evaluation of safety parameter AE and concomittant medication are Day 1, Day 8 and Day 43
    Timepoint of Evaluation of blood pressure and pulse rate are Day 1 and Day 43.
    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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    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 years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    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: 43
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 43
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state43
    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)
    Further treatment after the end of the trial is not planned unless adverse events make this necessary
    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 Decision2019-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-11
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