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    Summary
    EudraCT Number:2019-004119-30
    Sponsor's Protocol Code Number:IP-AVV2019
    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:2019-12-02
    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 number2019-004119-30
    A.3Full title of the trial
    EVALUATION OF THE ACCEPTABILITY AND EFFICACY OF 10 MICROGRAMS OF ESTRADIOL VAGINAL TABLETS VS PROMESTRIENE VAGINAL CREAM
    Evaluación de la aceptabilidad y eficacia de 10 microgramos de estradiol tabletas vaginales VS promestrieno crema
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EVALUATION OF THE ACCEPTABILITY AND EFFICACY OF 10 MICROGRAMS OF ESTRADIOL VAGINAL TABLETS VS PROMESTRIENE VAGINAL CREAM
    Evaluación de la aceptabilidad y eficacia de 10 microgramos de estradiol tabletas vaginales VS promestrieno crema
    A.4.1Sponsor's protocol code numberIP-AVV2019
    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 SponsorInstituto Palacios
    B.1.3.4CountrySpain
    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 supportInstituto Palacios
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto Palacios
    B.5.2Functional name of contact pointInstituto Palacios
    B.5.3 Address:
    B.5.3.1Street AddressAntonio acuña 9
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28009
    B.5.3.4CountrySpain
    B.5.4Telephone number+34915780517
    B.5.6E-mailinvestigacion@institutopalacios.com
    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 Vagifem
    D.2.1.1.2Name of the Marketing Authorisation holderIsdin, S.A.
    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 nameVAGIFEM
    D.3.2Product code 72171
    D.3.4Pharmaceutical form Vaginal tablet
    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 INNESTRADIOL HEMIHYDRATE
    D.3.9.1CAS number ESTRADIOL
    D.3.9.2Current sponsor code72171
    D.3.9.3Other descriptive nameVagifem
    D.3.9.4EV Substance CodeSUB11941MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Bq/mg becquerel(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.01
    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 COLPOTROFIN
    D.2.1.1.2Name of the Marketing Authorisation holderTheramex Ireland Limited
    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 nameCOLPOTROFIN
    D.3.2Product code 55594
    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 INNPROMESTRIENE
    D.3.9.1CAS number 39219-28-8
    D.3.9.2Current sponsor code55594
    D.3.9.3Other descriptive nameColpotrofin
    D.3.9.4EV Substance CodeSUB10087MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Bq/g becquerel(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 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.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
    ATROFIA VULVOVAGINAL
    E.1.1.1Medical condition in easily understood language
    VULVOVAGINAL ATROPHY
    ATROFIA VULVOVAGINAL
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    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 investigate acceptability of patients with vulvovaginal atrophy between 17B-Estradiol vaginal tablets and promestriene vaginal cream after 12 weeks.
    Objetivo Principal
    • Investigar la aceptabilidad en las pacientes con atrofia vulvovaginal entre las tabletas vaginales de 17B-Estradiol y la crema vaginal de promestrieno después de 12 semanas
    E.2.2Secondary objectives of the trial
    Efficacy:
    - To evaluate the relief of atrophic vaginitis symptoms using intensity ratings of none, mild, moderate or severe of dryness and dyspareunia.
    - To evaluate changes in ph.
    - To evaluate the vaginal maturation index by Pap smear.
    - To evaluate changes in soreness and irritation.
    Safety:
    - Occurrence of adverse events
    - Evaluation of endometrium thickness using vaginal ultrasound
    Objetivos secundarios
    • Evaluar el alivio de los síntomas de la atrofia vulvovaginal (sequedad y dispareunia)
    • Evaluar cambios en el Ph
    . Evaluar cambios en el índice de madurez citológica
    . Evaluar cambios en el dolor y la irritación
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Postmenopausal women aged 45 years or older. Women will be considered postmenopausal with more than 12 months since last menstrual period
    • Women who have read and signed the Informed Consent Form
    • Women with an intact uterus
    • One or more vaginal symptoms (dryness, soreness, irritation, dyspareunia) rated as moderate to severe. Symptoms are moderate if the patient needs a treatment and feels discomfort. Symptoms are severe if the patient needs a treatment, and feels such a degree of discomfort that this could severely impact the subject’s daily activities.
    • Blood estradiol concentration of 30 pg/ml or less .
    Mujer postmenopáusica mayor de 45 años(se consideran menopáusicas, mujeres con más de 12 meses de amenorrea)
    -Mujeres que han leído y firmado el Consentimiento informado
    - Mujeres con útero intacto
    - Mujeres con uno o más síntomas vaginales (sequedad, dolor, irritación, dispareunia) calificados como moderados o severos, cuyos síntomas sean tributarios de tratamiento.
    -Nivel de estradiol en sangre de 30pg/ml o menos.
    E.4Principal exclusion criteria
    Women who have not signed the Informed consent Form
    • Women who had a known or suspected history of breast carcinoma
    • Estrogen dependent neoplasia. Women with a known, past or suspected Estrogen-dependent malignant tumours such as endormetrial or ovarian cancer
    • Positive or suspicious mammogram results
    • Any systemic malignant disease
    • Hormone therapy treatment (sex hormones or vaginal treatments or steroids) in the last three months
    • Women who had abnormal vaginal bleeding or uterine bleeding of unknown cause
    • Vaginal infection requiring treatment
    • Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) Untreated endometrial hyperplasia Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency) Active or previous arterial thromboembolic disease (e.g. angina, myocardial infarction) Acute liver disease, or history of liver disease as long as liver function tests have failed to return to normal Known Hypersensitivity to the active substances or to any of the excipients Porphyria
    • Any serious disease or chronic condition that could interfere with study compliance
    • History of thrombolytic disorders
    • Use of vaginal contraceptives (DIU, vaginal ring…)
    • Participation in another clinical trial in the last three months.
    Mujeres que no firmen el Consentimiento Informado.
    - Mujeres con antecedentes conocidos o presuntos de carcinoma de mama
    - Neoplasia dependiente de estrógenos. Mujeres con tumores malignos dependientes de estrógenos conocidos o pasados
    - Resultados de mamografías positivas o sospechosas
    - Cualquier enfermedad maligna sistémica
    - Terapia hormonal (hormonas sexuales o tratamientos vaginales o esteroides) en los últimos tres meses
    - Mujeres que con sangrado vaginal anormal o hemorragia uterina de causa desconocida
    - Infección vaginal que requiere tratamiento
    - Tromboembolismo venoso anterior o actual (trombosis venosa profunda, embolia pulmonar), hiperplasia endometrial no tratada, trastornos trombofílicos conocidos (por ejemplo, proteína C, proteína S o deficiencia de antitrombina), enfermedad tromboembólica arterial activa o previa (por ejemplo, angina, infarto de miocardio), enfermedad hepática aguda o antecedentes de enfermedad hepática, siempre que las pruebas de función hepática no hayan logrado volver a la hipersensibilidad normal conocida a las sustancias activas o a alguno de los excipientes. Porfiria
    - Cualquier enfermedad grave o condición crónica que pueda interferir con el cumplimiento del estudio
    - Antecedentes de trastornos trombolíticos
    - Uso de anticonceptivos vaginales (DIU, anillo vaginal ...)
    - Participación en otro ensayo clínico en los últimos tres meses.
    E.5 End points
    E.5.1Primary end point(s)
    Patients with confirmed vulvovaginal atrophy diagnosis and symptoms of dryness, soreness, irritation and/or dyspareunia. 120 postmenopausal women older than 45 years will be selected to participate in the study.
    Mujeres postmenopáusicas mayores de 45 años con uno o más síntomas de atrofia vulvovaginal, con el diagnóstico de Atrofia Vulvovaginal moderada o severa, a quienes se les pondrá tratamiento con uno de los medicamentos del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Q3 2020
    TERCER TRIMESTRE 2020
    E.5.2Secondary end point(s)
    This study wants to evaluate the acceptability and preference of patients with vulvovaginal atrophy between 17B-Estradiol vaginal tablets and promestriene vaginal cream, as well as the efficacy of these treatments for VVA symptoms. During the study, vaginal examination, Vaginal Health Index, Pap smear, vaginal ultrasound and estradiol levels will be checked to verify the efficacy and safety of the treatment. Subjects will complete some questionnaires to check their satisfaction with the treatment and the acceptability.
    El estudio quiere evaluar la aceptabilidad y preferencia del estradiol en tabletas vaginales y promestrieno en crema en mujeres con atrofia vulvovaginal moderada o severa. Además, evaluar la eficacia y seguridad de dicho tratamiento a través de un examen de la salud vaginal, índice de madurez citológica, ecografía transvaginal y niveles de estradiol en sangre, así como la aceptabilidad del producto a través de un cuestionario de satisfacción.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Q3 2020
    TERCER TRIMESTRE 2020
    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) 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 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
    Jun 2020
    Junio 2020
    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 months6
    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: 120
    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 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 state120
    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)
    Not applicable
    No aplica
    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 Decision2020-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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