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    Clinical Trial Results:
    Metformin-Wirkung am Ovar bei PCOS (MAO-Studie) - eine Pilotstudie

    Summary
    EudraCT number
    		 2006-001911-31
    Trial protocol
    		 AT  
    Global end of trial date
    01 Oct 2008

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

    Trial information

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    Trial identification
    Sponsor protocol code
    30032006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52, Innsbruck, Austria, 6020
    Public contact
    Assoz. Prof. Priv.Doz. Dr. Beata Seeber, University Hospital for Gynaecological Endocrinology and Reproductive Medicine, Anichstr.35,6020 Ibk, +43 (0)512 504 23276, info.kinderwunsch@tirol-kliniken.at
    Scientific contact
    Assoz. Prof. Priv.Doz. Dr. Beata Seeber, University Hospital for Gynaecological Endocrinology and Reproductive Medicine, Anichstr.35,6020 Ibk, +43 (0)512 504 23276, info.kinderwunsch@tirol-kliniken.at
    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
    01 Oct 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    normalisation of hyperandrogenaemia in PCOS women
    Protection of trial subjects
    The subjects were instructed to take one tablet in the morning, midday and evening after a meal and not to alter their usual eating habits, physical activity, or lifestyle during the study. During the follow-up period, each subject returned for weekly clinical assessment including anthropometric measures, evaluation of serum progesterone (level > 5 μg/l confirmed ovulation), and documentation of menstrual bleeding.
    Background therapy
    		 -
    Evidence for comparator
    		 Ten women were randomly assigned to receive metformin 500 mg, three times daily and nine women to receive placebo three times daily for the following 2 days.
    Actual start date of recruitment
    27 Jun 2007
    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
    Austria: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    19
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Women with PCOS were recruited from the Department of Gynecological Endocrinology and Reproductive Medicine of the Innsbruck Medical University.

    Pre-assignment
    Screening details
    		 To be eligible for the study, subjects had to be between 18 and 40 years of age and have PCOS. All participants underwent a hormonal profile, an oral glucose tolerance test and an ACTH- stimulation test to exclude secondary causes of hyperandrogenism and manifest diabetes.

    Period 1
    Period 1 title
    Treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Randomization was accomplished by using a random number table. A copy of the randomization code was stored in a sealed envelope in the patient’s health record for emergency situations. The randomization code was not broken until the last patient completed all observations.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Metformin
    Arm description
    		 Ten women were randomly assigned to receive metformin 500 mg, three times daily for 2 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metformin hydrochloride
    Investigational medicinal product code
    Other name
    Glucophage
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg three times daily for 2 days

    Arm title
    		 Control
    Arm description
    		 Nine women were randomly assigned to receive placebo three times daily for 2 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three times daily for 2 days.

    Number of subjects in period 1
    		Metformin Control
    Started
    10
    9
    Completed
    10
    9
    Period 2
    Period 2 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The follow-up period was not blinded.

    Arms
    Arm title
    		 Follow-up
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metformin hydrochloride
    Investigational medicinal product code
    Other name
    Glucophage
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All study participants were then given metformin 500 mg twice daily for 1 week, followed by 500 mg three times daily to complete twelve weeks of therapy.

    Number of subjects in period 2
    		Follow-up
    Started
    19
    Completed
    18
    Not completed
    1
         Pregnancy
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Metformin
    Reporting group description
    		 Ten women were randomly assigned to receive metformin 500 mg, three times daily for 2 days.

    Reporting group title
    Control
    Reporting group description
    		 Nine women were randomly assigned to receive placebo three times daily for 2 days

    Reporting group values
    		 Metformin Control Total
    Number of subjects
    		 10 9 19
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 10 9 19
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 26.10 ( 4.25 ) 27.89 ( 4.83 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 9 19
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Metformin
    Reporting group description
    		 Ten women were randomly assigned to receive metformin 500 mg, three times daily for 2 days.

    Reporting group title
    Control
    Reporting group description
    		 Nine women were randomly assigned to receive placebo three times daily for 2 days
    Reporting group title
    Follow-up
    Reporting group description
    		 -

    Primary: Change AUC Testosterone

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    End point title
    		 Change AUC Testosterone
    End point description
    End point type
    Primary
    End point timeframe
    Day 1- day 4
    End point values
    		 Metformin Control
    Number of subjects analysed
    10
    9
    Units: Number
        arithmetic mean (standard deviation)
    -8.100 ( 2.188 )
    4.524 ( 4.69 )
    Statistical analysis title
    		 Change AUC Testosterone
    Comparison groups
    Metformin v Control
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.02
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0- week 12
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Metformin
    Reporting group description
    		 Ten women were randomly assigned to receive metformin 500 mg, three times daily for 2 days.

    Reporting group title
    Control
    Reporting group description
    		 Nine women were randomly assigned to receive placebo three times daily for 2 days

    Reporting group title
    Follow-up
    Reporting group description
    		 -

    Serious adverse events
    		 Metformin Control Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 19 (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: 5%
    Non-serious adverse events
    		 Metformin Control Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    4 / 19 (21.05%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    4 / 19 (21.05%)
         occurrences all number
    0
    0
    4
    Diarrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    4 / 19 (21.05%)
         occurrences all number
    0
    0
    4

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25304843
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