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    Clinical Trial Results:
    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.

    Summary
    EudraCT number
    		 2016-004506-34
    Trial protocol
    		 DK  
    Global end of trial date
    29 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2023
    First version publication date
    01 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    16.022
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Dorte Glintborg: Marianne Skovsager Andersen
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    J.B. Winsløws Vej 4, Odense, Denmark, 5000
    Public contact
    Pernille Ravn, Odense Universitetshospital, 0045 28435625, pernille.ravn@rsyd.dk
    Scientific contact
    Pernille Ravn, Odense Universitetshospital, 0045 28435625, pernille.ravn@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
    01 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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.
    Protection of trial subjects
    Participants gave written informed consent after oral and written information and time for consideration. The local Ethics committee and the Danish Medicines Agency approved the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 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
    		 We recruited participants through the PCOS outpatient clinic, Department of Gynecology and Obstetrics, Odense University Hospital, Denmark.

    Pre-assignment
    Screening details
    		 Inclusion criteria were: PCOS diagnosed according to the Rotterdam criteria (2) and age 18-50 years. Exclusion criteria were other causes of oligomenorrhea and/or hirsutism, including abnormal values of prolactin, TSH or 17-OH progesterone, postmenopausal values of FSH (>25 IE/l), type 2 diabetes (HbA1c > 48 mmol/mol) or type 1 diabetes.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Myoinositol (MI)
    Arm description
    		 MI was administered as one sachet of 2 mg MI and 200 mg Folic acid twice daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Myoinositol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Myoinositol 2 mg and Folic acid 200 mg in one sachet, twice daily.

    Arm title
    		 Metformin (MET)
    Arm description
    		 MET was administered as tablets of 500 mg and dose was one tablet twice daily for two weeks and two tablets twice daily hereafter.
    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
    Metformin was administered as tablets of 500 mg; one tablet twice daily for two weeks, and hereafter two tablets twice daily.

    Number of subjects in period 1
    		Myoinositol (MI) Metformin (MET)
    Started
    22
    23
    Completed
    16
    12
    Not completed
    6
    11
         Adverse event, non-fatal
    1
    5
         Pregnancy
    -
    4
         Lost to follow-up
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Myoinositol (MI)
    Reporting group description
    		 MI was administered as one sachet of 2 mg MI and 200 mg Folic acid twice daily.

    Reporting group title
    Metformin (MET)
    Reporting group description
    		 MET was administered as tablets of 500 mg and dose was one tablet twice daily for two weeks and two tablets twice daily hereafter.

    Reporting group values
    		 Myoinositol (MI) Metformin (MET) Total
    Number of subjects
    		 22 23 45
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 25 (22 to 34) 27 (24 to 33) -
    Gender categorical
    Units: Subjects
        Female
    		 22 23 45
        Male
    		 0 0 0
    Cycle length
    Units: days
        median (inter-quartile range (Q1-Q3))
    		 45 (35 to 175) 47 (35 to 82) -
    BMI
    Units: kg/m^2
        median (inter-quartile range (Q1-Q3))
    		 34.2 (30.9 to 37.2) 35.2 (31.0 to 39.8) -

    End points

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    End points reporting groups
    Reporting group title
    Myoinositol (MI)
    Reporting group description
    		 MI was administered as one sachet of 2 mg MI and 200 mg Folic acid twice daily.

    Reporting group title
    Metformin (MET)
    Reporting group description
    		 MET was administered as tablets of 500 mg and dose was one tablet twice daily for two weeks and two tablets twice daily hereafter.

    Primary: HOMA-IR

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    End point title
    		 HOMA-IR
    End point description
    End point type
    Primary
    End point timeframe
    Baseline values
    End point values
    		 Myoinositol (MI) Metformin (MET)
    Number of subjects analysed
    16
    12
    Units: pmol mmol l^-2
        median (inter-quartile range (Q1-Q3))
    28.5 (19.6 to 45.6)
    30.9 (24.9 to 32.4)
    Statistical analysis title
    		 Statistical analysis plan
    Statistical analysis description
    Mann-Whitney U test was used to compare baseline data and delta-values (6-0 months) MI vs. MET. Wilcoxon Signed-Rank test was used to test within-group changes in MI and MET groups. Statistical analysis used for all endpoints.
    Comparison groups
    Metformin (MET) v Myoinositol (MI)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: SF-36

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    End point title
    		 SF-36
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline values
    End point values
    		 Myoinositol (MI) Metformin (MET)
    Number of subjects analysed
    14
    12
    Units: Score on a scale
    median (inter-quartile range (Q1-Q3))
        Physical functioning
    90 (75 to 95)
    90 (85 to 95)
        Role limitations due to physical health
    88 (50 to 100)
    100 (75 to 100)
        Role limitations due to emotional problems
    100 (0 to 100)
    100 (50 to 100)
        Energy/fatigue
    50 (35 to 60)
    40 (25 to 65)
        Emotional well-being
    74 (60 to 84)
    72 (58 to 84)
        Social functioning
    59 (45 to 80)
    53 (36 to 73)
        Pain
    58 (45 to 90)
    74 (68 to 95)
        General health
    65 (50 to 80)
    58 (38 to 80)
    No statistical analyses for this end point

    Secondary: HDL

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    End point title
    		 HDL
    End point description
    High-density Lipoprotein
    End point type
    Secondary
    End point timeframe
    Baseline values
    End point values
    		 Myoinositol (MI) Metformin (MET)
    Number of subjects analysed
    16
    12
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    1.2 (1.0 to 1.3)
    1.3 (1.2 to 1.4)
    No statistical analyses for this end point

    Secondary: Insulin (fasting)

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    End point title
    		 Insulin (fasting)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline values
    End point values
    		 Myoinositol (MI) Metformin (MET)
    Number of subjects analysed
    16
    12
    Units: pmol/L
        median (inter-quartile range (Q1-Q3))
    126 (85 to 190)
    117 (112 to 143)
    No statistical analyses for this end point

    Secondary: Glucose (fasting)

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    End point title
    		 Glucose (fasting)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline values
    End point values
    		 Myoinositol (MI) Metformin (MET)
    Number of subjects analysed
    16
    12
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    5.2 (5.0 to 5.4)
    5.3 (5.1 to 5.7)
    No statistical analyses for this end point

    Secondary: BMI

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    End point title
    		 BMI
    End point description
    Body Mass Index
    End point type
    Secondary
    End point timeframe
    Basline values
    End point values
    		 Myoinositol (MI) Metformin (MET)
    Number of subjects analysed
    16
    12
    Units: kg/m2
        median (inter-quartile range (Q1-Q3))
    34.2 (30.9 to 37.2)
    35.2 (31.0 to 39.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of the study till end.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD10
    Dictionary version
    ICD10
    Reporting groups
    Reporting group title
    Myoinositol (MI)
    Reporting group description
    		 MI was administered as one sachet of 2 mg MI and 200 mg Folic acid twice daily.

    Reporting group title
    Metformin (MET)
    Reporting group description
    		 MET was administered as tablets of 500 mg and dose was one tablet twice daily for two weeks and two tablets twice daily hereafter.

    Serious adverse events
    		 Myoinositol (MI) Metformin (MET)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Myoinositol (MI) Metformin (MET)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 22 (18.18%)
    16 / 23 (69.57%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    2 / 22 (9.09%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Mood swings
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Increased body hair
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Gastrointestinal adverse events
    Additional description: Nausea, diarrhoea, vomiting and opstipation.
         subjects affected / exposed
    1 / 22 (4.55%)
    12 / 23 (52.17%)
         occurrences all number
    1
    12
    Reproductive system and breast disorders
    Irregular menstrual cycle
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0

    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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