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    Summary
    EudraCT Number:2014-005129-10
    Sponsor's Protocol Code Number:Elovaara09112014
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-12
    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 ConcernedFinland - Fimea
    A.2EudraCT number2014-005129-10
    A.3Full title of the trial
    Multiple Sclerosis and Menopause: the effect of hormone replacement therapy on clinical picture and immunology of multiple sclerosis
    MS-tauti ja vaihdevuodet: hormonikorvaushoidon vaikutus MS-taudin kliiniseen kuvaan ja immunologiaan
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multiple Sclerosis, menopause and hormone replacement therapy
    MS-tauti, vaihdevuodet ja hormonikorvaushoito
    A.4.1Sponsor's protocol code numberElovaara09112014
    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 SponsorIrina Elovaara
    B.1.3.4CountryFinland
    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 supportTampere University hospital
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIrina Elovaara
    B.5.2Functional name of contact pointIrina Elovaara
    B.5.3 Address:
    B.5.3.1Street AddressUniversity of Tampere, Medical School, Department of Neurology, Lääkärinkatu 1, Arvo Building, B322
    B.5.3.2Town/ cityUniversity of Tampere
    B.5.3.3Post codeFI-33014
    B.5.3.4CountryFinland
    B.5.4Telephone number+358401904110
    B.5.6E-mailirina.elovaara@uta.fi
    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 Femoston 2/10
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Oy
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameFemoston 2/10
    D.3.4Pharmaceutical form 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 HEMIHYDRATE
    D.3.9.1CAS number 35380-71-3
    D.3.9.4EV Substance CodeSUB11941MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDYDROGESTERONE
    D.3.9.1CAS number 152-62-5
    D.3.9.4EV Substance CodeSUB06433MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 Femoston 1/10
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Oy
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameFemoston 1/10
    D.3.4Pharmaceutical form 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 HEMIHYDRATE
    D.3.9.1CAS number 35380-71-3
    D.3.9.4EV Substance CodeSUB11941MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDYDROGESTERONE
    D.3.9.1CAS number 152-62-5
    D.3.9.4EV Substance CodeSUB06433MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Multiple sclerosis
    MS-tauti
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis
    MS-tauti
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10064137
    E.1.2Term Progression of multiple sclerosis
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10070425
    E.1.2Term Multiple sclerosis exacerbation
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To define the effect of menopause on clinical picture, physical and cognitive functions and quality of life in female with relapsing-remitting multiple sclerosis.
    Tutkimuksessa selvitetään menopaussin vaikutuksia aaltomaista MS-tautia sairastavien naisten kliiniseen kuvaan (oireet ja löydökset), toimintakykyyn, kognitiiviseen suoriutumiseen ja elämänlaatuun.
    E.2.2Secondary objectives of the trial
    To research the effect of hormone replacement therapy on menopausal symptoms, quality of life, subjective and objective physical and cognitive functions, activity of the disease, immunology and MRI findings in female with multiple sclerosis.
    Tutkimuksessa selvitetään hormonikorvaushoidon tehoa menopaussi-oireisiin, elämänlaatuun, neurologiseen toimintakykyyn, MS-taudin aktiivisuuteen, objektiiviseen kognitiiviseen suoriutumiseen, itseraportoituihin oireisiin (koetut kognitiiviset oireet, uupumus, unettomuus, mieliala) , immunologiaan ja magneettikuvamuutoksiin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Gender: female
    - Age 44-54 years
    - Peri- or postmenopausal
    - Course of diasease: relapsing-remitting
    - Multiple sclerosis is diagnosed with valid diagnostic criteria (valid at the time of the diagnosis)
    - Active disease (relapse or new T2- or Gd+ -lesion in MRI within a year)
    - EDSS max. 5.5
    - No estrogen/progestin or estrogen in use or two months wash-out period
    - No treatment or interferon beta, glatiramer acetate or teriflunomide for multiple sclerosis
    - Sukupuoli: nainen
    - Ikä: 44-54 vuotta
    - Peri- tai postmenopaussi todettu
    - Tautityyppi: aaltomaisesti etenevä (RRMS) MS-tauti
    - Diagnoosihetkellä voimassa olevin kriteerein todettu MS-tauti
    - Aktiivinen tauti (edeltävän vuoden aikana pahenemisvaihe tai uusi T2- tai gadoliniumtehosteinen muutos aivojen magneettikuvauksessa)
    - EDSS-pisteet tutkimuksen alussa korkeintaan 5,5
    - Ei systeemistä estrogeeni/progestiini- tai estrogeenilääkitystä käytössä tai valmiste ollut pois käytöstä tutkimuksen alkaessa vähintään kaksi kuukautta
    - Ei MS-tautiin vaikuttavaa lääkitystä tai käytössä ns. esilinjan lääke (beetainterferoni, glatirameeriasetaatti tai teriflunomidi)
    E.4Principal exclusion criteria
    - Course of disease: primary or secondary progressive multiple sclerosis or clinically isolated syndrome
    - EDSS more than 5.5
    - Use of estrogen/progestin or estrogen without two months wash-out period
    - Severe other health medical condition (e.g. malignancy, other autoimmune or neurodegenerative disease, severe psycholocigal disease)
    - Contraindication for hormone replacement therapy
    - Other immunomodulatory treatment than interferon beta, glatiramere acetate or teriflunomidi
    - Tautityyppi: primaaristi progressiivinen MS, sekundaarisprogressiivinen MS tai kliinisesti eriytynyt oireyhtymä (KEO)
    - Pitkälle edennyt sairaus (EDSS > 5,5)
    - Systeeminen estrogeeni/progestiini- tai estrogeenilääkitys käytössä
    - Vakava muu sairaus (kuten syöpätauti, muu autoimmuunisairaus tai neurodegeneratiivinen sairaus, vaikea-asteinen psyykkinen sairaus)
    - Vasta-aihe hormonikorvaushoidolle
    - Muu immunomoduloiva lääkitys kuin beetainterferoni, glatirameeriasetaatti tai teriflunomidi
    E.5 End points
    E.5.1Primary end point(s)
    Disease progression:
    1 point EDSS progression within a year is considered as a clinically significant change if EDSS in the beginning is 0-3.5.
    0,5 point EDSS progression within a year is considered as a clinically significant change if EDSS in the beginning is 4.0-5.5.
    Taudin progression osalta kliinisesti merkitseväksi muutokseksi katsotaan 1 EDSS-pisteen suureneminen vuoden seurannassa, mikäli EDSS tutkimuksen alussa on 0-3,5 ja 0,5 pisteen suureneminen, jos EDSS on 4,0-5,5.
    E.5.1.1Timepoint(s) of evaluation of this end point
    0 and 12 months
    0 ja 12 kuukautta
    E.5.2Secondary end point(s)
    Objective cognitive functions: statistically significant difference between the test results in the beginning and in the end
    Objektiivisen kognitiivisen suoriutumisen osalta merkittäväksi muutokseksi katsotaan tilastollisesti merkittävä ero testituloksessa tutkimuksen alussa ja lopussa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    0, 3 and 12 months
    0, 3 ja 12 kuukautta
    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 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 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 Yes
    E.8.2.3.1Comparator description
    Terveet verrokit
    Healthy control subjects
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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: 40
    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 Yes
    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)
    Post trial treatment will be carried out by neurologist, gynecologist or general practitioner who has taken care of treatment and follow-up of the subjects before the study.
    Tutkimuksen jälkeen osallistujat jatkavat heitä aiemmin hoitaneen neurologin, gynekologin tai yleislääkärin hoidossa ja seurannassa.
    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 Decision2015-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-31
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