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    Summary
    EudraCT Number:2016-004506-34
    Sponsor's Protocol Code Number:16.022
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-21
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-004506-34
    A.3Full title of the trial
    The effect of myoinositol (MI) or metformin treatment on symptoms of polycystisk ovary syndrome (PCOS), including metabolism, menstrual pattern, quality of life and mental health.
    Effekten af myoinositol vs. metformin på antropometriske værdier, glukose metabolisme, menstruationsmønster og livskvalitet ved polycystisk ovariesyndrom (PCOS). - Et randomiseret, prospektivt, kontrolleret studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of myoinositol (MI) or metformin treatment on symptoms of polycystisk ovary syndrome (PCOS), including metabolism, menstrual pattern, quality of life and mental health.
    Effekten af myoinositol vs. metformin på antropometriske værdier, glukose metabolisme, menstruationsmønster og livskvalitet ved polycystisk ovariesyndrom (PCOS). - Et randomiseret, prospektivt, kontrolleret studie.
    A.3.2Name or abbreviated title of the trial where available
    Myoinositol or metformin in PCOS
    Myoinositol eller metformin i PCOS
    A.4.1Sponsor's protocol code number16.022
    A.5.4Other Identifiers
    Name:Dorte GlintborgNumber:Marianne Skovsager Andersen
    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 SponsorOdense Universitetshospital
    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 supportBiO4U Ltd., Eugene O'Connor, info@bio-4-u.com, 6-9 Trinity St, Dublin 2, Tel +45 31 54 83 68
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense Universitetshospital
    B.5.2Functional name of contact pointPernille Ravn
    B.5.3 Address:
    B.5.3.1Street AddressSdr. Boulevard 29
    B.5.3.2Town/ cityOdense C
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number004528435625
    B.5.6E-mailpernille.ravn@rsyd.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 Metformin
    D.2.1.1.2Name of the Marketing Authorisation holderActavis A/S
    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 namemetformin
    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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 1115-70-40
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    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
    Polycystic ovarian syndrome (PCOS)
    Polycystisk ovarie syndrom (PCOS)
    E.1.1.1Medical condition in easily understood language
    Polycystic ovarian syndrome (PCOS)
    Polycystisk ovarie syndrom (PCOS)
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10065161
    E.1.2Term Polycystic ovarian syndrome
    E.1.2System Organ Class 100000004872
    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 the effect of the dietary supplement myoinositol compared to the drug metformin in women with polycystic ovarian syndrome (PCOS). PCOS is characterized by irregular menstruations, high blood levels of male hormones, and increased male hair growth. Myoinositol and metformin decrease insulin resistance. The effect of myoinositol on symptoms of PCOS is not fully investigated and we investigate the effect compared to standard treatment with metformin. In the trial we investigate the effect on anthropometric measures, glucose metabolism, blood lipids, mental health, quality of life, sex hormones, menstrual pattern and side effects.
    Undersøgelsen belyser hvorledes behandling med kosttilskuddet myoinositol påvirker kvinder med polycystisk ovariesyndrom (PCOS) sammenlignet med gængs behandling med lægemidlet metformin. PCOS er karakteriseret ved uregelmæssige menstruationer, højt niveau af mandligt hormon, og øget hårvækst. Myoinositol og metformin nedsætter insulinresistens, men effekten på symptomer ved PCOS er forsat sparsomt belyst. Vi ønsker at belyse effekten på antropometriske værdier, glukosemetabolisme, blodlipider, mentalt helbred, livskvalitet, kønshormoner, menstruationsmønster samt bivirkninger.
    E.2.2Secondary objectives of the trial
    Not applicable
    Ikke relevant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18-50 years
    Women with PCOS
    Alder 18-50 år
    Kvinder med PCOS
    E.4Principal exclusion criteria
    Postmenopausal
    Dysregulated type 2 diabetes
    Type 1 diabetes
    Use of systemic hormonal contraceptives within 3 months
    Use og metformin within 1 month
    Postmenopausal
    Dysreguleret type 2 diabetes
    Type 1 diabetes
    Brug af p-piller indenfor de sidste 3 måneder
    Brug af metformin indenfor den sidste måned
    E.5 End points
    E.5.1Primary end point(s)
    Insulin sensitivity estimated by homeostatic model assessment of insulin resistance (HOMA-IR)
    Insulinfølsomhed vurderet ved homeostatic model assessment of insulin resistance (HOMA-IR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and after 6 months' treatment
    Baseline og efter 6 måneders behandling
    E.5.2Secondary end point(s)
    Changes in anthropometric measures, glucose metabolism, blood lipids, mental health, quality of life, sex hormones, menstrual pattern and side effects.
    Ændringer i antropometriske værdier, glukosemetabolisme, blodlipider, mentalt helbred, livskvalitet, kønshormoner, menstruationsmønster samt bivirkninger.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and after 6 months' treatment
    Baseline og efter 6 måneders behandling
    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 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 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
    Myoinositol (et kosttilskud)
    Myoinositol (a dietary supplement)
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 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 Yes
    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.3.3.6.1Details of subjects incapable of giving consent
    Myoinositol and metformin are not teratogenic. Contraception is thus not mandatory. However, as we want to investigate the effect on PCOS in non-pregnant women, we enroll women without a present wish for pregnancy.
    Myoinositol og metformin er ikke teratogene. Kontraception er derfor ikke obligatorisk. Men da vi ønsker at undersøge effekten af myoinositol og metformin på PCOS til ikke-gravide kvinder, inkluderer vi kvinder uden aktuelt graviditetsønske.
    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)
    The women will be followed in the outpatient clinic according to standard for up for 6-12 months after ending in the trial
    Kvinderne følges i ambulatoriet i henhold til standard i yderligere 6-12 måneder efter afslutning i studiet
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Odense Universitetshospital
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-29
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