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    Summary
    EudraCT Number:2019-001435-31
    Sponsor's Protocol Code Number:RES-2026-C12
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-001435-31
    A.3Full title of the trial
    Prospective and open clinical trial to evaluate the rapidity of action of a 0.005% estriol vaginal gel on the signs and symptoms of vaginal atrophy in postmenopausal women. BLISSET Study.
    Ensayo clínico prospectivo y abierto para evaluar la rapidez de acción de un gel vaginal de estriol al 0,005% sobre los signos y síntomas de atrofia vaginal en mujeres postmenopáusicas
    “Estudio BLISSET”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective and open clinical trial to evaluate the rapidity of action of a 0.005% estriol vaginal gel on the signs and symptoms of vaginal atrophy in postmenopausal women. BLISSET Study
    Ensayo clínico prospectivo y abierto para evaluar la rapidez de acción de un gel vaginal de estriol al 0,005% sobre los signos y síntomas de atrofia vaginal en mujeres postmenopáusicas.
    Estudio BLISSET.
    A.3.2Name or abbreviated title of the trial where available
    BLISSET Study
    Estudio BLISSET
    A.4.1Sponsor's protocol code numberRES-2026-C12
    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 SponsorITF Research Pharma S.L.U.
    B.1.3.4CountrySpain
    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 supportITF RESEARCH PHARMA S.L.U.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALPHA BIORESEARCH S.L.
    B.5.2Functional name of contact pointTeresa Bricio
    B.5.3 Address:
    B.5.3.1Street AddressCalle López de Hoyos 155, 3ª planta
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28002
    B.5.3.4CountrySpain
    B.5.4Telephone number0034917452520
    B.5.5Fax number0034917450653
    B.5.6E-mailregulatory@alphabioresearch.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 Yes
    D.2.1.1.1Trade name Blissel
    D.2.1.1.2Name of the Marketing Authorisation holderITF Research Pharma S.L.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameBlissel
    D.3.4Pharmaceutical form Vaginal gel
    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.3.9.1CAS number 50-27-1
    D.3.9.4EV Substance CodeSUB01971MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Genitourinary syndrome of menopause (GSM)
    Síndrome Genitourinario de la Menopausia (SGM)
    E.1.1.1Medical condition in easily understood language
    Genitourinary syndrome of menopause (GSM)
    Síndrome Genitourinario de la Menopausia (SGM)
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10051775
    E.1.2Term Postmenopause
    E.1.2System Organ Class 10041244 - Social circumstances
    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 is to evaluate the rapidity of action of vaginal estriol gel at 0.005% in the treatment of vaginal atrophy in postmenopausal women with symptoms of vaginal atrophy.
    • El objetivo principal consiste en evaluar la rapidez de acción del gel vaginal de estriol al 0.005% en el tratamiento de la atrofia vaginal en mujeres postmenopáusicas con síntomas de atrofia vaginal.
    E.2.2Secondary objectives of the trial
    • Evaluate the efficacy of vaginal estriol gel at 0.005% on the different symptoms and signs of vaginal atrophy in postmenopausal women with symptoms of vaginal atrophy.

    • Evaluate the safety and tolerability of estriol vaginal gel at 0.005% administered during two weeks in postmenopausal women with symptoms of vaginal atrophy.

    • Evaluate the acceptability of estriol vaginal gel at 0.005% administered during two weeks in postmenopausal women with symptoms of vaginal atrophy.
    • Evaluar la eficacia del gel vaginal de estriol al 0.005% sobre los distintos síntomas y signos de atrofia vaginal en mujeres postmenopáusicas con síntomas de atrofia vaginal.

    • Evaluar la seguridad y tolerabilidad del gel vaginal de estriol al 0.005% administrado durante dos semanas en mujeres postmenopáusicas con síntomas de atrofia vaginal.

    • Evaluar la aceptabilidad del gel vaginal de estriol al 0.005% administrado durante dos semanas en mujeres postmenopáusicas con síntomas de atrofia vaginal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women between 45 and 75 years old.
    • Postmenopausal women (who have at least 12 months without menstruation) by natural process or by surgical intervention.
    • Women who present with vaginal symptoms resulting from vaginal atrophy, at least moderate-severe vaginal dryness, and in whom a local estrogen treatment is considered necessary to relieve their symptoms.
    • Mujeres de entre 45 y 75 años.
    • Mujeres postmenopáusicas (que lleven como mínimo 12 meses sin tener la menstruación) por proceso natural o por intervención quirúrgica.
    • Mujeres que presenten síntomas vaginales derivados de la atrofia vaginal, al menos sequedad vaginal moderada-severa, y en las que se considere preciso un tratamiento estrogénico por vía local para alivio de su sintomatología.
    E.4Principal exclusion criteria
    • Women with a history of malignant or premalignant lesions in breast or endometrium, malignant colon or hepatic tumors, malignant melanoma, venous thromboembolic disorders (deep vein thrombosis, pulmonary embolism) or arterial thromboembolic disorders (cardiac ischemia, myocardial infarction, cerebrovascular accident) , peripheral arterial disease, thrombosis of the mesenteric artery, thrombosis of the renal artery or coagulopathies.

    • Women with vaginal bleeding of unknown etiology.

    • Women with uterovaginal prolapse grade II or higher, or signs and symptoms suggestive of infection of the genitals or urinary tract.

    • Women with an endometrial thickness equal to or greater than 4 mm measured by transvaginal ultrasound before the start of the study.

    • Women who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study.

    • Women who have received phytoestrogens within 1 month before the start of the study (including vaginal administration).

    • Women who have received hormone therapy in the 3 months before the start of the study (including the administration of estrogen via the vagina).

    • Women who are being treated with estrogen or progestin, tibolone or selective modulators of the estrogen receptor, antiepileptic and urinary antiseptics.

    • Women who have received long-term antibiotic treatment (for two or more weeks) in the last 3 months before the start of the study.

    • Women in treatment with medications such as: antiepileptic drugs, antibiotics and anti-infectives.

    • Women who, for any reason, the researcher considers that they are not candidates to participate in this study.
    • Mujeres con antecedentes de lesiones malignas o premalignas en mama o endometrio, tumores malignos de colon o hepáticos, melanoma maligno, trastornos tromboembólicos venosos (trombosis venosa profunda, embolia pulmonar) o trastornos tromboembólicos arteriales (isquemia cardiaca, infarto de miocardio, accidente cerebrovascular), enfermedad arterial periférica, trombosis de la arteria mesentérica, trombosis de la arteria renal o coagulopatías.

    • Mujeres con sangrado vaginal de etiología desconocida.

    • Mujeres con prolapso uterovaginal de grado II o superior, o signos y síntomas sugestivos de infección de los genitales o tracto urinario.

    • Mujeres con un grosor endometrial igual o superior a 4 mm medido por ultrasonido transvaginal antes del inicio del estudio.

    • Mujeres que hayan recibido cualquier tipo de tratamiento vulvovaginal en los 15 días previos al inicio del estudio.

    • Mujeres que hayan recibido fitoestrógenos en el transcurso de 1 mes antes del inicio del estudio (incluida la administración vía vaginal).

    • Mujeres que hayan recibido terapia hormonal en los 3 meses antes del inicio del estudio (incluida la administración de estrógenos vía vaginal).

    • Mujeres que estén en tratamiento con estrógenos o progestágenos, tibolona o moduladores selectivos del receptor de estrógenos, antiepilépticos y antisépticos urinarios.

    • Mujeres que hayan recibido tratamiento antibiótico de larga duración (durante dos o más semanas) en los últimos 3 meses antes del inicio del estudio.

    • Mujeres en tratamiento con medicamentos tales como: fármacos antiepilépticos, antibióticos y antiinfecciosos.

    • Mujeres que, por cualquier motivo, el investigador considere que no son candidatas a participar en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in the vaginal epithelium maturation value compared to the baseline values ​​after two weeks of treatment with estriol vaginal gel at 0.005%.
    Cambios en el valor de maduración del epitelio vaginal frente a los valores basales tras dos semanas de tratamiento con el gel vaginal de estriol al 0.005%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days
    14 días
    E.5.2Secondary end point(s)
    Changes in the value of vaginal maturation after one week of treatment with vaginal estriol gel at 0.005% against baseline values.

    Changes in vaginal pH after one and two weeks of treatment compared to baseline values.

    Changes in vaginal dryness and other symptoms and signs of vaginal atrophy after one and two weeks of treatment against baseline.

    Evolution of the symptoms collected in the diary of the patient in weeks 1 and 2 of treatment.

    Determination of adverse events according to the Medical Dictionary for Regulatory Activities (MedDRA).

    To evaluate the acceptability after two weeks of treatment with vaginal estriol gel at 0.005%. For its determination, the patient must answer a simple questionnaire regarding the properties that the product confers (moisturizing capacity and cleanliness of the product) and its evaluation in relation to the general effectiveness of the therapy.
    Cambios en el valor de maduración vaginal tras una semana de tratamiento con el gel vaginal de estriol al 0.005% frente a valores basales.

    Cambios en el pH vaginal tras una y dos semanas de tratamiento frente a los valores basales.

    Cambios en la sequedad vaginal y otros síntomas y signos de atrofia vaginal tras una y dos semanas de tratamiento frente a los valores basales.

    Evolución de los síntomas recogidos en el diario de la paciente en las semanas 1 y 2 de tratamiento.

    Determinación de acontecimientos adversos según el Diccionario Médico para Actividades Regulatorias (MedDRA).

    Evaluar la aceptabilidad tras dos semanas de tratamiento con el gel vaginal de estriol al 0.005%. Para su determinación la paciente deberá responder un cuestionario sencillo en relación a las propiedades que confiere el producto (capacidad hidratante y la limpieza del producto) y a su valoración en relación a la efectividad general de la terapia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 days
    14 días
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial1
    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 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
    LPLV
    Last Patient Last Visit
    Última Visita Último Paciente
    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 months5
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    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)
    Usual Clinical Practice
    Práctica Clínica Habitual
    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 Decision2019-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-22
    P. End of Trial
    P.End of Trial StatusOngoing
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