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    Summary
    EudraCT Number:2016-002199-28
    Sponsor's Protocol Code Number:VFCr-12/2015
    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:2016-09-07
    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 number2016-002199-28
    A.3Full title of the trial
    Prospective, open-label, multicenter, multinational, randomized trial to investigate the non-inferiority of treatment with Vagisan® Moisturising Cream in comparison to an Estriol containing cream in a panel of post-menopausal women suffering from the symptoms of "vulvovaginal dryness" in a parallel group design
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of non-inferiority of treatment of "vulvovaginal dryness" with Vagisan® Moisturising Cream in comparison to an Estriol containing cream
    A.4.1Sponsor's protocol code numberVFCr-12/2015
    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 AddressSudbrackstrasse 56
    B.5.3.2Town/ cityBielefeld
    B.5.3.3Post code33611
    B.5.3.4CountryGermany
    B.5.4Telephone number004905218808319
    B.5.5Fax number004905218808474
    B.5.6E-mailclarissa.masur@wolff-arzneimittel.de
    D. IMP Identification
    D.IMP: 1
    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 Ovestin 1 mg Creme
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    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 nameOvestin 1 mg Creme
    D.3.4Pharmaceutical form 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 INNESTRIOL
    D.3.9.3Other descriptive nameOvestin
    D.3.9.4EV Substance CodeSUB01971MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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.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
    postmenopausal women suffering from symptoms of vulvovaginal dryness
    E.1.1.1Medical condition in easily understood language
    postmenopausal women suffering from symptoms of vulvovaginal dryness
    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 PT
    E.1.2Classification code 10047791
    E.1.2Term Vulvovaginal dryness
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    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 non-inferiority of the treatment of "vulvovaginal dryness" with Vagisan® Moisturising Cream in comparison to an Estriol containing cream.
    The comparison will be based on the subjective assessment of the symptoms of "vulvovaginal dryness" (Total Severity Score: sum score of the single subjective symptom parameters dryness, itching, burning and pain unrelated to sexual intercourse).
    E.2.2Secondary objectives of the trial
    •Severity scoring for each of the subjective symptoms
    •Impairment of daily life due to each subjective symptom
    •Mean sum score for severity of the subjective symptoms and impairment of daily life
    •Severity scoring for dyspareunia
    •Impairment of daily life due to dyspareunia
    •Overall impairment of daily life due to the condition “vaginal dryness”, including subgroup analysis of patients with mild, moderate or severe impairment
    •Vaginal Health Index
    •Comparison of Vagisan® Moisturising Cream to Estriol containing cream on (AUC) over the course of the study for all above given parameters.
    •Vaginal status of Lactobacillus flora
    •Global judgement of efficacy by the Investigator/patient
    •Global judgement of tolerability by the Investigator/patient
    •Safety parameters
    •Pre-treatment of "vulvovaginal dryness" and satisfaction with the respective product
    •Urinary incontinence
    •Questionnaire about satisfaction
    •Dose and frequency of the treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Post-menopausal women with the subjective symptomatology of “vulvovaginal dryness” with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a VAS value “Overall impairment of daily life due to the condition “vulvovaginal dryness” > 0 on Visit 1.
    •Last menstruation more than 12 months before Visit 1 OR bilateral oophorectomy with or without hysterectomy more than 3 months before Visit 1.
    •Physical and mental healthy women as assessed by the medical history.
    •PAP test performed within the last 12 months before Visit 1 and result less than PAP III
    •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.
    •Any indication in the medical history regarding an impairment of the hepatic, renal, gastrointestinal, cardiovascular, pulmonary, endocrinological or hematological system (especially venous and arterial thromboembolism, ischemic stroke, myocardial infarction, porphyria) if clinically relevant for this clinical trial (cf. contraindications and warnings for Ovestin®).
    •Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency).
    •Any indication of other significant acute or chronic impairments which may have an impact either on the safety of the patient or on the resorption, distribution, metabolism or the excretion of estriol.
    •Breast cancer (acute and / or in the medical history or suspected).
    •Estrogen-dependent tumor (acute and / or in the medical history or suspected, especially ovarian and / or endometrial carcinoma).
    •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.
    •Intrauterine device (IUD) with progestogen (Mirena®, Jaydess®)
    •Untreated endometrial hyperplasia
    •Undiagnosed vaginal bleeding.
    •Pathological findings in cancer screening (Papanicolaou III, III D – V in the cervical test)
    •Pathological changes in the vaginal or cervix area, which are caused by estrogen deficiency (except symptoms and condition of "vulvovaginal dryness"), e.g. diminution of labia caused by estrogen deficiency, constricted introitus.
    •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 dryness".
    •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 products, applied intravaginally or on the vulva during the conduct of this trial (except for the use of Vagisan® Intimwaschlotion, Note: should not be used, if allergic to chamomile).
    •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.
    •Body Mass Index < 19 kg/m2 or > 35 kg/m2.
    •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 Total Severity Score is defined as the sum of the single parameters dryness, itching, burning and pain unrelated to sexual intercourse, each scored from 0 = none to 4 = very severe. In total a range of 0 = no complaints to 16 = very severe complaints is possible.
    Differences to Baseline (Visit 1) of the Total Severity Score assessed after six weeks of treatment (Visit 3) serve as the primary endpoint for the test of non-inferiority.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks
    E.5.2Secondary end point(s)
    •Severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) at each visit and once weekly
    •AUC for severity scoring for each of the subjective symptoms over all assessment time points (at each visit and once weekly)
    •Impairment of daily life due to each subjective symptom at each visit and once weekly
    •AUC for impairment of daily life due to each subjective symptom over all assessment time points (at each visit and once weekly)
    •Mean sum score for severity of the subjective symptoms and impairment of daily life due to each subjective symptom at each visit and once weekly. For better interpretation severity scoring will be recalculated to a scale from 0 to 10 resulting in: mean sum score = (severity scoring + impairment of daily life) / 8
    •AUC for this mean sum score over all assessment time points (at each visit and once weekly)
    •Severity scoring for dyspareunia (if sexually active) at each visit
    •AUC for severity scoring for dyspareunia (if sexually active) over all assessment time points (at each visit)
    •Impairment of daily life due to dyspareunia (if sexually active) at each visit
    •AUC for impairment of daily life due to dyspareunia (if sexually active) over all assessment time points (at each visit)
    •Overall impairment of daily life due to the condition “vaginal dryness”, including a subgroup analysis of patients with mild, moderate and severe overall impairment at each visit
    •AUC for overall impairment of daily life over all assessment time points (at each visit)
    •Vaginal Health Index, for each parameter, and as sum score over objective assessment of vaginal findings at each visit
    •AUC for Vaginal Health Index (for each parameter, and as sum score) over all assessment time points (at each visit)
    •Vaginal status of Lactobacillus flora on Visit 1 and on Visit 3
    •Global judgment of the efficacy by the Investigator on Visit 3
    •Global judgment of the efficacy by the patient on Visit 3
    Safety Assessments:
    •Global judgment of the tolerability by the Investigator on Visit 3
    •Global judgment of the tolerability by the patient on Visit 3
    •Safety parameters (adverse events, concomitant medication)
    Further Assessments:
    •Pre-treatment of "vulvovaginal dryness" and satisfaction with the respective product on Visit 1
    •Urinary incontinence at each visit
    •Questionnaire about satisfaction with the respective test product on Visit 3
    •Dose and frequency of the treatment with the respective test product
    E.5.2.1Timepoint(s) of evaluation of this end point
    Single severity scores for the subjective symptoms, Impairment of daily life, Overall impairment at each visit and once weekly
    •Dyspareunia, Impairment of daily life, Objective assessment of the vagina, aconuresis at each visit
    •Vaginal status of Lactobacillus flora on Visit 1 and on Visit 3
    •Global efficacy by the Investigator, Global efficacy by the Patient, Global tolerability by the Investigator, Global tolerability by the Patient, Questionnaire on Visit 3
    •Safety parameters (adverse events, concomitant medication)
    on Visits 1, 2, 3
    •Pre-treatment of vulvovaginal dryness and satisfaction with the respective product on Visit 1
    •Dose and frequency of the treatment with the respective product (daily)
    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 No
    E.6.4Safety No
    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 Yes
    E.6.13.1Other scope of the trial description
    Non-Inferiority trial
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    Switzerland
    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
    The end of the trial is defined as the last visit of the last patient.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 86
    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 state152
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 152
    F.4.2.2In the whole clinical trial 172
    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. At the final visit further treatments for vulvovaginal dryness will be discussed with the patients.
    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 Decision2016-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
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