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    Clinical Trial Results:
    Effect of the combined treatment with myo-inositol and metformin on the phenotype of the polycystic ovary syndrome: a pilot study

    Summary
    EudraCT number
    		 2008-006991-31
    Trial protocol
    		 IT  
    Global end of trial date
    31 Jan 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Oct 2022
    First version publication date
    13 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    143/2008/U/Sper
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IRCCS n- Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
    Sponsor organisation address
    Via Albertoni 15, Bologna, Italy, 40138
    Public contact
    Alessandra Gambineri , IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi,UO Endocrinologia, 0039 3477738178, alessandra.gambiner3@unibo.it
    Scientific contact
    Alessandra Gambineri , IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi,UO Endocrinologia, 0039 3477738178, alessandra.gambiner3@unibo.it
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Dec 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary aim of the study is to evaluate the impact of 6 months treatment with myo-inositol and metformin on insulin resistance of women with the polycystic ovary syndrome (PCOS) when compared with myo-inositol or metformin alone
    Protection of trial subjects
    Yes, by specific insurance
    Background therapy
    		 none
    Evidence for comparator
    		 Literature
    Actual start date of recruitment
    19 Jun 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 45
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    45
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment according to a list of randomization

    Pre-assignment
    Screening details
    		 Screening performed according to inclusion and exclusion criteria

    Pre-assignment period milestones
    Number of subjects started
    		 45
    Number of subjects completed
    		 45

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Myo+Met
    Arm description
    		 Myo-inositol 4g/die plus Metformin 1700mg/die
    Arm type
    		 No IMP

    Investigational medicinal product name
    Myo-inositol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral/rectal suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    4g/die

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pastille, Pillules
    Routes of administration
    Oral use
    Dosage and administration details
    1700mg/die

    Arm title
    		 Myo-inositol
    Arm description
    		 Myo-inositol 4g/die
    Arm type
    		 NO IMP

    Investigational medicinal product name
    Myo-inositol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution, Powder for oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    4g/die

    Arm title
    		 Metformin
    Arm description
    		 Metformin 1700mg/die
    Arm type
    		 NO IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Myo+Met Myo-inositol Metformin
    Started
    15
    15
    15
    Completed
    14
    15
    14
    Not completed
    1
    0
    1
         Adverse event, not serious
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Myo+Met
    Reporting group description
    		 Myo-inositol 4g/die plus Metformin 1700mg/die

    Reporting group title
    Myo-inositol
    Reporting group description
    		 Myo-inositol 4g/die

    Reporting group title
    Metformin
    Reporting group description
    		 Metformin 1700mg/die

    Reporting group values
    		 Myo+Met Myo-inositol Metformin Total
    Number of subjects
    		 15 15 15 45
    Age categorical
    Adults (18-64 years)
    Units: Subjects
        Adults (18-64 years)
    		 15 15 15 45
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 23.4 ( 4.9 ) 25.5 ( 3.9 ) 24.3 ( 4 ) -
    Gender categorical
    female
    Units: Subjects
        female
    		 15 15 15 45
    Glucose
    fasting blood glucose
    Units: mg/dl
        arithmetic mean (standard deviation)
    		 82.5 ( 7.6 ) 86.3 ( 8.2 ) 82.5 ( 7.6 ) -
    blood insulin
    fasting blood insulin
    Units: µUI/mL
        arithmetic mean (standard deviation)
    		 9.72 ( 3.23 ) 8.38 ( 3.89 ) 9.54 ( 4.47 ) -

    End points

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    End points reporting groups
    Reporting group title
    Myo+Met
    Reporting group description
    		 Myo-inositol 4g/die plus Metformin 1700mg/die

    Reporting group title
    Myo-inositol
    Reporting group description
    		 Myo-inositol 4g/die

    Reporting group title
    Metformin
    Reporting group description
    		 Metformin 1700mg/die

    Primary: blood glucose

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    End point title
    		 blood glucose
    End point description
    fasting blood glucose
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Myo+Met Myo-inositol Metformin
    Number of subjects analysed
    14 [1]
    15
    14 [2]
    Units: mmol/dl
        arithmetic mean (standard deviation)
    82.5 ( 7.6 )
    86.3 ( 08.2 )
    83.9 ( 10.1 )
    Notes
    [1] - one drop out
    [2] - one drop out
    Statistical analysis title
    		 ANOVA
    Comparison groups
    Myo+Met v Myo-inositol v Metformin
    Number of subjects included in analysis
    43
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority [3]
    P-value
    		 ≥ 1 [4]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [3] - TWO-WAY ANOVA (Time x treatment)
    [4] - not significant

    Primary: blood insulin

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    End point title
    		 blood insulin
    End point description
    fasting blood insulin
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Myo+Met Myo-inositol Metformin
    Number of subjects analysed
    14 [5]
    15
    14 [6]
    Units: µUI/ml
        arithmetic mean (standard deviation)
    8.28 ( 3.89 )
    9.54 ( 4.47 )
    9.72 ( 3.23 )
    Notes
    [5] - one drop out
    [6] - one drop out
    Statistical analysis title
    		 ANOVA
    Comparison groups
    Myo+Met v Myo-inositol v Metformin
    Number of subjects included in analysis
    43
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority [7]
    P-value
    		 ≥ 1 [8]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [7] - TWO-WAY ANOVA (Time x treatment)
    [8] - not significant

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    one month
    Adverse event reporting additional description
    gastrointestinal disease
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    arm1
    Reporting group description
    		 -

    Reporting group title
    arm2
    Reporting group description
    		 -

    Reporting group title
    arm 3
    Reporting group description
    		 -

    Serious adverse events
    		 arm1 arm2 arm 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0.04%
    Non-serious adverse events
    		 arm1 arm2 arm 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    14
    15
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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