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    The EU Clinical Trials Register currently displays   38942   clinical trials with a EudraCT protocol, of which   6397   are clinical trials conducted with subjects less than 18 years old.
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    Clinical Trial Results:
    A non-blinded randomised trial on the effect of metformin vs. metformin and oral contraceptives vs. oral contraceptives on glucosetolerance, insulin resistance, growth hormone and cortisol metabolism in polycystic ovary syndrome

    Summary
    EudraCT number
    2006-004763-57
    Trial protocol
    DK  
    Global end of trial date
    01 Sep 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Nov 2020
    First version publication date
    22 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PCOS, metformin og p-piller 2006.
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    kløvervænget 6, Odense, Denmark, 5000
    Public contact
    Department of endocrinology, Odense University Hospital, department of endocrinology, 0045 65412502,
    Scientific contact
    Marianne Andersen, Odense University Hospital, department of endocrinology, 0045 65412502, msa@rsyd.dk
    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
    29 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effects of oral contraceptives vs. metformin vs. metformin and oral contraceptives in patients with polycystic ovary syndrome on two points: Insulin resistance Glucose tolerance
    Protection of trial subjects
    regional data monitoring comitee + ethical comitee + GCP unit
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    12 Oct 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 90
    Worldwide total number of subjects
    90
    EEA total number of subjects
    90
    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)
    90
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    90 women aged 18-39 years fulfilling the Rotterdam criteria for PCOS were included in the study

    Pre-assignment
    Screening details
    90 women aged 18-39 years fulfilling the Rotterdam criteria for PCOS were included in the study

    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
    Meformin
    Arm description
    metformin
    Arm type
    Active comparator

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 g x 2

    Arm title
    oral contaceptive
    Arm description
    oral contraceptive
    Arm type
    Active comparator

    Investigational medicinal product name
    Oral contraceptive
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    21 active/ 7 day pause

    Arm title
    Metformin and Oral contraceptive
    Arm description
    Metformin and Oral contraceptive
    Arm type
    Active comparator

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 g x 2

    Investigational medicinal product name
    Oral contraceptive
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    21 day active/7 days pause

    Number of subjects in period 1
    Meformin oral contaceptive Metformin and Oral contraceptive
    Started
    30
    30
    30
    baseline
    30
    23
    30
    12 months
    19
    23
    23
    Completed
    19
    23
    23
    Not completed
    11
    7
    7
         Lost to follow-up
    11
    7
    7

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Meformin
    Reporting group description
    metformin

    Reporting group title
    oral contaceptive
    Reporting group description
    oral contraceptive

    Reporting group title
    Metformin and Oral contraceptive
    Reporting group description
    Metformin and Oral contraceptive

    Primary: weight

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    End point title
    weight
    End point description
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    Meformin oral contaceptive Metformin and Oral contraceptive
    Number of subjects analysed
    19
    23
    23
    Units: kg
        median (inter-quartile range (Q1-Q3))
    -3 (-10.3 to 0.6)
    1.2 (-0.8 to 3.0)
    -1.9 (-4.9 to 0.1)
    Statistical analysis title
    Statistical analysis
    Comparison groups
    Meformin v oral contaceptive v Metformin and Oral contraceptive
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    Regression, Linear
    Parameter type
    Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Metformin
    Reporting group description
    -

    Reporting group title
    Metformin + oc
    Reporting group description
    -

    Reporting group title
    oral contraceptive
    Reporting group description
    -

    Serious adverse events
    Metformin Metformin + oc oral contraceptive
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Metformin Metformin + oc oral contraceptive
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 30 (10.00%)
    3 / 30 (10.00%)
    Gastrointestinal disorders
    nausea
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 30 (10.00%)
    3 / 30 (10.00%)
         occurrences all number
    1
    3
    3

    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/33112812
    http://www.ncbi.nlm.nih.gov/pubmed/29658344
    http://www.ncbi.nlm.nih.gov/pubmed/28834135
    http://www.ncbi.nlm.nih.gov/pubmed/28432082
    http://www.ncbi.nlm.nih.gov/pubmed/26194691
    http://www.ncbi.nlm.nih.gov/pubmed/24906976
    http://www.ncbi.nlm.nih.gov/pubmed/24742124
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