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    Summary
    EudraCT Number:2019-001881-14
    Sponsor's Protocol Code Number:20072650
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-14
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-001881-14
    A.3Full title of the trial
    Endocrine, cardiovascular, pharmacologic and physiologic aspects of sex hormone treatment in Turner syndrome - project part 1
    Endokrinologiske, kardiovaskulære, farmakologiske og fysiologiske aspekter ved kønshormonbehandling ved Turner syndrom - projekt del 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hormonal, cardiovascular, medical, muscle- and fitness aspects of sex hormone treatment in patients with Turner syndrome - project part 1
    Hormonel, hjertekar, medicinsk, muskel- og konditionsmæssige aspekter ved kønshormonbehandling hos patienter med Turner syndrom - projekt del 1
    A.3.2Name or abbreviated title of the trial where available
    Aspects of sex hormone treatment in Turner syndrome
    Aspekter af kønshormonbehandling ved Turner syndrom
    A.4.1Sponsor's protocol code number20072650
    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 SponsorDepartment of Endocrinology and Internal Medicine, Aarhus University Hospital
    B.1.3.4CountryDenmark
    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 supportAarhus Universityhospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAarhus University
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Endocrinology and Internal Medicine, Aarhus Universityhospital
    B.5.2Functional name of contact pointMedical Research Lab
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 165
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number004578455470
    B.5.6E-mailauh.doh.klinik@rm.dk
    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 Estrofem
    D.2.1.1.2Name of the Marketing Authorisation holderDanish Medicines Agency
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Film-coated tablet
    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 INNEstradiol
    D.3.9.3Other descriptive nameESTRADIOL
    D.3.9.4EV Substance CodeSUB07242MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Divigel
    D.2.1.1.2Name of the Marketing Authorisation holderDanish Medicines Agency
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameDivigel
    D.3.2Product code 9688
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEstradiol
    D.3.9.3Other descriptive nameESTRADIOL
    D.3.9.4EV Substance CodeSUB07242MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    Ovarian dysgenesis and related hypogonadism caused by Turner syndrome
    Ovariedysfunktion og relateret hypogonadisme forårsaget af Turner syndrom
    E.1.1.1Medical condition in easily understood language
    Failure of the ovaries and related decreased production of female sex hormone, estrogen, caused by the congenital Turner syndrome
    Manglede funktion af æggestokkene og dermed relateret nedsat produktion af kvindelig kønshormon, østrogen, forårsaget af det medfødte Turner syndrom
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10045181
    E.1.2Term Turner's syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Find the equipotency for different estradiol regimens, oral versus transdermal (TD) route of administration, using different estradiol-dependent surrogate markers.
    1. Finde ækvipotens for forskellige østradiolregimer, oral versus transdermal (TD) administrationsvej, ved hjælp af forskellige østradiol-afhængige surrogatmarkører.
    E.2.2Secondary objectives of the trial
    Not applicable
    Ikke anvendelig
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For participants with TS:
    - Diagnosis of TS regardless of karyotype
    - Age 18-50 years
    - Receives estrogen treatment in advance
    For deltagerne med TS:
    - Diagnose med TS uanset karyotype
    - Alderen 18-50 år
    - Modtager behandling med østrogen i forvejen
    E.4Principal exclusion criteria
    - Active systemic chronic diseases
    - Known with or with suspicion of breast cancer
    - Known or suspected estradiol-dependent tumors (endometrial cancer or similar)
    - Untreated endometrial hyperplasia
    - Current or past venous thromboembolism
    - Acute or previous liver disease, where liver enzymes are still elevated by at least a factor of 3
    - Known hypersensitivity to active substances or excipients in any of the used medicines
    - Pregnancy
    - Aktive systemiske kroniske sygdomme
    - Kendt med eller med mistanke om brystkræft
    - Kendt med eller med mistanke om østradiolafhængige tumorer (endometriecancer eller lignende)
    - Ubehandlet endometrie hyperplasi
    - Nuværende eller tidligere venøs tromboembolisme
    - Akut eller tidligere leversygdom, hvor leverenzymerne stadig er forhøjet med mindst en faktor på 3
    - Kendt overfølsomhed overfor aktive stoffer eller hjælpestoffer i nogen af de anvendte lægemidler
    - Graviditet
    E.5 End points
    E.5.1Primary end point(s)
    Dose equivalence for tablet and gel therapy, which is the dosage that leads to the same levels of sex hormones in the blood of the participants.
    Dosisækvivalens for tablet og gelbehandling i form af den dosering, der fører til samme værdier af kønshormoner i blodet hos deltagerne.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Participants with Turner syndrome will have blood tests with female sex hormones taken on day 0 and day 14 of the study.
    Deltagerne med Turner syndrom vil få taget blodprøver med kvindelig kønshormoner på dag 0 og dag 14 i undersøgelsen.
    E.5.2Secondary end point(s)
    None
    Ingen
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    Ingen
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    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 No
    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 Yes
    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 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
    The trial will end when the last participants has gone through the last examination day (after the two times two weeks of treatment with one week in between without medicine) blood tests are taken on the last examination day 35.
    Forsøget afsluttes, når den sidste deltager har gennemgået den sidste undersøgelsesdag (efter to gange to ugers behandling og en uge i mellem uden behandling) tages blodprøver på sidste undersøgelsesdag 3).
    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 months
    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: 50
    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 state50
    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)
    After completing the project, patients return to their usual medication. If, during the trial, there are indications that they are not receiving the correct dosage, their regular therapists are advised if patients so desire for dose optimization.
    Efter endt projekt går patienter tilbage til deres vanlige medicin. Såfremt der under forsøget findes indikationer for de ikke får den korrekte dosering, underrettes der vanlige behandler såfremt patienterne ønsker dette med henblik på dosisoptimering.
    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 Decision2021-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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