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    Clinical Trial Results:
    Prospective, randomised, double-blind, placebo-controlled, single centre phase IIa clinical trial to investigate the safety and tolerability as well as the impact of a substitution of sexual hormones with an estrogen-progestin combination over 10 weeks in addition to in-house psychotherapy on neuro-endocrinological parameters, psychopathology and neuro-psychological performance compared to in-house psychotherapy alone in adult females with anorexia nervosa

    Summary
    EudraCT number
    2015-004184-36
    Trial protocol
    DE  
    Global end of trial date
    14 Jan 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Aug 2020
    First version publication date
    12 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UKER-AN-HS-01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Erlangen
    Sponsor organisation address
    Schwabachanlage 6, Erlangen, Germany, 91054
    Public contact
    Psychosomatische Abteilung, Universitätsklinikum Erlangen, +49 91318534898, George.Paslakis@uhn.ca
    Scientific contact
    Psychosomatische Abteilung, Universitätsklinikum Erlangen, George.Paslakis@uhn.ca
    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
    14 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jan 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Quantification of the impact of the substitution of sexual hormones with an estrogen-progestin combination in addition to in-house psychotherapy on the neuro-psychological performance of female subjects with anorexia nervosa, measured by TMT A and B, Go/NoGo test and WCST
    Protection of trial subjects
    Each subject was examined by a gynecologist prior to randomization and was excluded from study participation in case of contraindications (smoker, vascular complications in medical history or familiy history). Inpatient Setting during the entire period of participation with regular physical examinations, lab checks etc.
    Background therapy
    Inpatient psychotherapy
    Evidence for comparator
    Placebo-controlled
    Actual start date of recruitment
    04 Jan 2016
    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
    Germany: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    females aged between 18 and 45 years, Anorexia nervosa acc. DSM 5 or sub-syndromal Anorexia nervosa, BMI ≥13 kg/m2 and ≤18,5 kg/m2

    Period 1
    Period 1 title
    Screening
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Verum
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    MAXIM 0,030mg/2mg coated tablet, encapsulated
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    daily dose: 1 capsule (0,03mg ethinylestradiol / 2mg dienogest), Duration of Administration: 10 weeks

    Arm title
    Control
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Daily dose: 1 capsule; Duration of Administration: 10 weeks

    Number of subjects in period 1
    Verum Control
    Started
    6
    5
    Completed
    6
    5
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Verum
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    MAXIM 0,030mg/2mg coated tablet, encapsulated
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    daily dose: 1 capsule (0,03mg ethinylestradiol / 2mg dienogest), Duration of Administration: 10 weeks

    Arm title
    Control
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Daily dose: 1 capsule; Duration of Administration: 10 weeks

    Number of subjects in period 2
    Verum Control
    Started
    6
    5
    Completed
    4
    5
    Not completed
    2
    0
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    -
    Period 3
    Period 3 title
    Post-treatment
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Verum
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    MAXIM 0,030mg/2mg coated tablet, encapsulated
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    daily dose: 1 capsule (0,03mg ethinylestradiol / 2mg dienogest), Duration of Administration: 10 weeks

    Arm title
    Control
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Daily dose: 1 capsule; Duration of Administration: 10 weeks

    Number of subjects in period 3
    Verum Control
    Started
    4
    5
    Completed
    4
    3
    Not completed
    0
    2
         Lost to follow-up
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Screening
    Reporting group description
    -

    Reporting group values
    Screening Total
    Number of subjects
    11 11
    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
        arithmetic mean (standard deviation)
    25.27 ( 7.90 ) -
    Gender categorical
    Units: Subjects
        Female
    11 11
        Male
    0 0
    BMI
    Units: kg per square meter
        arithmetic mean (standard deviation)
    15.75 ( 1.59 ) -
    TMT A
    neuropsychological Performance test, evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    TMT B
    neuropsychological Performance test, evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    WCST errors
    neuropsychological Performance test, evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    WCST perseveration
    neuropsychological Performance test, evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    EDE-Q
    evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    EDI-2
    evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    STAI state
    evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    STAI trait
    evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    go/no-go test: Reaction times (RT)
    evaluated at V3 (day1): Food-shift: Verum: 398.89 +/- 31.58; Placebo: 379.29 +/- 23.87 Food-nonshift: Verum: 384.31 +/- 29.96; Placebo: 379.94 +/- 24.57 Neutral-shift: Verum: 403.54 +/- 25.66; Placebo: 385.40 +/- 17.97 Neutral-nonshift: see below
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    go/no-go test: Commission errors (CE)
    evaluated at V3 (day1): Food-shift: Verum: 3.75 +/- 3.20; Placebo:4.80 +/- 6.42 Food-nonshift: Verum: 1.00 +/- 1.16; Placebo: 2.80 +/- 2.78 Neutral-shift: Verum: 6.25 +/- 4.50; Placebo: 7.80 +/- 1.64 Neutral-nonshift: see below
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    PHQ-9
    evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    EDQoL
    evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    LH
    Units: Unit(s)/litre
        arithmetic mean (standard deviation)
    ( ) -
    FSH
    Units: Unit(s)/litre
        arithmetic mean (standard deviation)
    ( ) -
    Estradiol
    Units: nanogram(s)/litre
        arithmetic mean (standard deviation)
    ( ) -
    Testosteron
    Units: microgram(s)/litre
        arithmetic mean (standard deviation)
    ( ) -
    Cortisol
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    Ghrelin-OGTT
    0 min: Verum: 537.41 +/- 122.43; Placebo: 963.26 +/- 266.79 30 min: Verum: 417.64 +/- 129.85; Placebo: 814.96 +/- 175.24 60 min: Verum: 399.14 +/- 108.48; Placebo: 749.55 +/-218.63 90 min: Verum: 413.94 +/- 123.93; Placebo: 700.69 +/- 210.80 120 min: see below
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    Leptin-OGTT
    0 min: Verum: 9.33 +/- 6.01; Placebo: 1.26 +/- 1.60 30 min: Verum: 9.07 +/- 4.95; Placebo: 0.82 +/- 0.89 60 min: Verum: 9.37 +/- 5.10; Placebo: 1.04 +/- 1.28 90 min: Verum: 7.79 +/- 4.58; Placebo: 0.94 +/- 1.16 120 min: see below
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    Insulin-OGTT
    0 min: Verum: 10.60 +/- 2.96; Placebo: 4.40 +/- 2.52 30 min: Verum: 78.08 +/- 18.28; Placebo: 64.37 +/- 40.40 60 min: Verum: 83.10 +/- 37.71; Placebo: 74.04 +/- 56.71 90 min: Verum: 70.48 +/- 47.50; Placebo: 77.30 +/- 49.68 120 min: see below
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    Glucose-OGTT
    0 min: Verum: 95.95 +/- 15.77; Placebo: 85.73 +/- 8.81 30 min: Verum: 156.87 +/- 44.23; Placebo: 134.08 +/- 27.36 60 min: Verum: 129.90 +/- 56.59; Placebo: 146.46 +/- 55.91 90 min: Verum: 104.80 +/- 36.75; Placebo: 136.00 +/- 61.13 120 min: see below
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( ) -
    Subject analysis sets

    Subject analysis set title
    Verum Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    subjects randomized to Verum and treated for 10 weeks (until v6)

    Subject analysis set title
    Placebo group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    subjects randomized to Placebo and treated for 10 weeks (until v6)

    Subject analysis set title
    Verum group II
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    subjects randomized to Verum, treated for 10 weeks (until v6) and followed up until v7 (day 113 +/- 7 days)

    Subject analysis set title
    Placebo Group II
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    subjects randomized to placebo, treated for 10 weeks (until v6) and followed up until v7 (day 113 +/- 7 days)

    Subject analysis sets values
    Verum Group Placebo group Verum group II Placebo Group II
    Number of subjects
    4
    5
    4
    3
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    BMI
    Units: kg per square meter
        arithmetic mean (standard deviation)
    16.38 ( 1.73 )
    15.22 ( 1.75 )
    ( )
    ( )
    TMT A
    neuropsychological Performance test, evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    29.50 ( 10.78 )
    28.37 ( 7.76 )
    ( )
    ( )
    TMT B
    neuropsychological Performance test, evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    41.52 ( 6.81 )
    53.45 ( 24.61 )
    ( )
    ( )
    WCST errors
    neuropsychological Performance test, evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    11.25 ( 10.05 )
    7.60 ( 2.30 )
    ( )
    ( )
    WCST perseveration
    neuropsychological Performance test, evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    5.00 ( 4.08 )
    4.00 ( 0.71 )
    ( )
    ( )
    EDE-Q
    evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( )
    ( )
    3.18 ( 1.28 )
    3.57 ( 0.57 )
    EDI-2
    evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( )
    ( )
    312.25 ( 85.11 )
    324.33 ( 69.90 )
    STAI state
    evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( )
    ( )
    52.50 ( 15.20 )
    45.67 ( 17.62 )
    STAI trait
    evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( )
    ( )
    58.50 ( 14.64 )
    54.67 ( 13.58 )
    go/no-go test: Reaction times (RT)
    evaluated at V3 (day1): Food-shift: Verum: 398.89 +/- 31.58; Placebo: 379.29 +/- 23.87 Food-nonshift: Verum: 384.31 +/- 29.96; Placebo: 379.94 +/- 24.57 Neutral-shift: Verum: 403.54 +/- 25.66; Placebo: 385.40 +/- 17.97 Neutral-nonshift: see below
    Units: unit(s)
        arithmetic mean (standard deviation)
    400.20 ( 23.54 )
    396.00 ( 29.84 )
    ( )
    ( )
    go/no-go test: Commission errors (CE)
    evaluated at V3 (day1): Food-shift: Verum: 3.75 +/- 3.20; Placebo:4.80 +/- 6.42 Food-nonshift: Verum: 1.00 +/- 1.16; Placebo: 2.80 +/- 2.78 Neutral-shift: Verum: 6.25 +/- 4.50; Placebo: 7.80 +/- 1.64 Neutral-nonshift: see below
    Units: unit(s)
        arithmetic mean (standard deviation)
    4.00 ( 3.65 )
    5.20 ( 3.03 )
    ( )
    ( )
    PHQ-9
    evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( )
    ( )
    0.75 ( 0.50 )
    0.67 ( 0.58 )
    EDQoL
    evaluated at V3 (day1)
    Units: unit(s)
        arithmetic mean (standard deviation)
    ( )
    ( )
    34.75 ( 19.38 )
    35.33 ( 11.02 )
    LH
    Units: Unit(s)/litre
        arithmetic mean (standard deviation)
    2.55 ( 2.16 )
    3.87 ( 3.94 )
    ( )
    ( )
    FSH
    Units: Unit(s)/litre
        arithmetic mean (standard deviation)
    3.14 ( 1.43 )
    4.32 ( 3.44 )
    ( )
    ( )
    Estradiol
    Units: nanogram(s)/litre
        arithmetic mean (standard deviation)
    50.70 ( 87.81 )
    16.49 ( 28.56 )
    ( )
    ( )
    Testosteron
    Units: microgram(s)/litre
        arithmetic mean (standard deviation)
    0.13 ( 0.08 )
    0.13 ( 0.04 )
    ( )
    ( )
    Cortisol
    Units: unit(s)
        arithmetic mean (standard deviation)
    8.62 ( 1.84 )
    73.04 ( 81.44 )
    ( )
    ( )
    Ghrelin-OGTT
    0 min: Verum: 537.41 +/- 122.43; Placebo: 963.26 +/- 266.79 30 min: Verum: 417.64 +/- 129.85; Placebo: 814.96 +/- 175.24 60 min: Verum: 399.14 +/- 108.48; Placebo: 749.55 +/-218.63 90 min: Verum: 413.94 +/- 123.93; Placebo: 700.69 +/- 210.80 120 min: see below
    Units: unit(s)
        arithmetic mean (standard deviation)
    403.73 ( 157.86 )
    734.98 ( 248.21 )
    ( )
    ( )
    Leptin-OGTT
    0 min: Verum: 9.33 +/- 6.01; Placebo: 1.26 +/- 1.60 30 min: Verum: 9.07 +/- 4.95; Placebo: 0.82 +/- 0.89 60 min: Verum: 9.37 +/- 5.10; Placebo: 1.04 +/- 1.28 90 min: Verum: 7.79 +/- 4.58; Placebo: 0.94 +/- 1.16 120 min: see below
    Units: unit(s)
        arithmetic mean (standard deviation)
    8.69 ( 5.06 )
    1.05 ( 1.33 )
    ( )
    ( )
    Insulin-OGTT
    0 min: Verum: 10.60 +/- 2.96; Placebo: 4.40 +/- 2.52 30 min: Verum: 78.08 +/- 18.28; Placebo: 64.37 +/- 40.40 60 min: Verum: 83.10 +/- 37.71; Placebo: 74.04 +/- 56.71 90 min: Verum: 70.48 +/- 47.50; Placebo: 77.30 +/- 49.68 120 min: see below
    Units: unit(s)
        arithmetic mean (standard deviation)
    75.09 ( 46.45 )
    105.31 ( 109.48 )
    ( )
    ( )
    Glucose-OGTT
    0 min: Verum: 95.95 +/- 15.77; Placebo: 85.73 +/- 8.81 30 min: Verum: 156.87 +/- 44.23; Placebo: 134.08 +/- 27.36 60 min: Verum: 129.90 +/- 56.59; Placebo: 146.46 +/- 55.91 90 min: Verum: 104.80 +/- 36.75; Placebo: 136.00 +/- 61.13 120 min: see below
    Units: unit(s)
        arithmetic mean (standard deviation)
    97.74 ( 6.74 )
    106.21 ( 42.85 )
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Verum
    Reporting group description
    -

    Reporting group title
    Control
    Reporting group description
    -
    Reporting group title
    Verum
    Reporting group description
    -

    Reporting group title
    Control
    Reporting group description
    -
    Reporting group title
    Verum
    Reporting group description
    -

    Reporting group title
    Control
    Reporting group description
    -

    Subject analysis set title
    Verum Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    subjects randomized to Verum and treated for 10 weeks (until v6)

    Subject analysis set title
    Placebo group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    subjects randomized to Placebo and treated for 10 weeks (until v6)

    Subject analysis set title
    Verum group II
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    subjects randomized to Verum, treated for 10 weeks (until v6) and followed up until v7 (day 113 +/- 7 days)

    Subject analysis set title
    Placebo Group II
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    subjects randomized to placebo, treated for 10 weeks (until v6) and followed up until v7 (day 113 +/- 7 days)

    Primary: Change of the neuropsychological performance measured by TMT A after 10 weeks of psychotherapy and sexual hormone substitution compared to V3 (day1) the intervention group vs. the group with psychotherapy alone

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    End point title
    Change of the neuropsychological performance measured by TMT A after 10 weeks of psychotherapy and sexual hormone substitution compared to V3 (day1) the intervention group vs. the group with psychotherapy alone
    End point description
    End point type
    Primary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    4
    5
    Units: unit(s)
        arithmetic mean (standard deviation)
    27.27 ( 5.59 )
    26.63 ( 8.40 )
    Statistical analysis title
    TMT A
    Statistical analysis description
    Change in TMT A between V3 and V6 compared between Verum Group and Placebo group
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.86 [1]
    Method
    ANOVA
    Confidence interval
    Notes
    [1] - rm-ANOVA with 1rm factor (pre:V3/post:V6); TMT A as dependent variable and Group (Placebo vs. Verum) as between-subject factor.

    Primary: Change of the neuropsychological performance measured by TMT B after 10 weeks of psychotherapy and sexual hormone substitution compared to V3 (day1) the intervention group vs. the group with psychotherapy alone

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    End point title
    Change of the neuropsychological performance measured by TMT B after 10 weeks of psychotherapy and sexual hormone substitution compared to V3 (day1) the intervention group vs. the group with psychotherapy alone
    End point description
    End point type
    Primary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    4
    5
    Units: unit(s)
        arithmetic mean (standard deviation)
    39.28 ( 3.71 )
    35.50 ( 3.51 )
    Statistical analysis title
    TMT B
    Statistical analysis description
    Change in TMT B between v3 (day 1) and v6 (day 73+/-3) compared between Verum Group and Placebo Group
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.6 [2]
    Method
    ANOVA
    Confidence interval
    Notes
    [2] - rm ANOVA with 1rm factor (pre/post), TMT B as dependent variable and Group (Placebo vs. Verum) as between-subject factor.

    Primary: Change of the neuropsychological performance measured by WCST errors after 10 weeks of psychotherapy and sexual hormone substitution compared to V3 (day1) in the intervention group vs. the group with psychotherapy alone

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    End point title
    Change of the neuropsychological performance measured by WCST errors after 10 weeks of psychotherapy and sexual hormone substitution compared to V3 (day1) in the intervention group vs. the group with psychotherapy alone
    End point description
    End point type
    Primary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    4
    5
    Units: unit(s)
        arithmetic mean (standard deviation)
    7.50 ( 1.29 )
    6.80 ( 1.64 )
    Statistical analysis title
    WCST errors
    Statistical analysis description
    Change in WCST Errors between visit 3 (day1) and visit 6 (day 73+/-3) compared between Verum Group and Placebo group
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.42 [3]
    Method
    ANOVA
    Confidence interval
    Notes
    [3] - rm-ANOVA with 1 factor (pre/post), WCST Errors as dependent variable and Group as between-subject factor.

    Primary: Change of the neuropsychological performance measured by WCST perseveration after 10 weeks of psychotherapy and sexual hormone substitution compared to V3 (day1) in the intervention group vs. the group with psychotherapy alone

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    End point title
    Change of the neuropsychological performance measured by WCST perseveration after 10 weeks of psychotherapy and sexual hormone substitution compared to V3 (day1) in the intervention group vs. the group with psychotherapy alone
    End point description
    End point type
    Primary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    4
    5
    Units: unit(s)
        arithmetic mean (standard deviation)
    3.75 ( 0.50 )
    2.80 ( 1.30 )
    Statistical analysis title
    WCST perseveration
    Statistical analysis description
    Change in WCST Perseveration between visit 3 (day 1) and visit 6 (day 73 +/- 3 days) compared between Verum Group and Placebo group
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.37 [4]
    Method
    ANOVA
    Confidence interval
    Notes
    [4] - rm ANOVA with 1 factor (pre/post), WCST Perseveration as dependent variable and Group as between-subject factor

    Primary: Change of the neuropsychological performance measured by go/no-go test: RT after 10 weeks of psychotherapy and sexual hormone substitution compared to V3 (day1) the intervention group vs. the group with psychotherapy alone

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    End point title
    Change of the neuropsychological performance measured by go/no-go test: RT after 10 weeks of psychotherapy and sexual hormone substitution compared to V3 (day1) the intervention group vs. the group with psychotherapy alone
    End point description
    Food-shift: Verum: 387.99 +/- 22.19; Placebo: 372.58 +/- 20.90 Food-nonshift: Verum: 385.39 +/- 30.98; Placebo: 370.72 +/- 19.68 Neutral-shift: Verum: 382.99 +/- 20.15; Placebo: 390.28 +/- 18.18 Neutral-nonshift: see below
    End point type
    Primary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    4
    5
    Units: unit(s)
        arithmetic mean (standard deviation)
    384.12 ( 15.12 )
    378.63 ( 20.30 )
    Statistical analysis title
    go/no-go: Reaction times (RT)
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.54 [5]
    Method
    ANOVA
    Confidence interval
    Notes
    [5] - rm ANOVA with 3 rm factors (category: Food vs. neutral; shift-Status: shift vs. non-shift; time: V3/V6/V7); significant main effect of time (p=0.013); significant main effect of category (p=0.036); no main effect for group

    Primary: Change of the neuropsychological performance measured by go/no-go test: CE after 10 weeks of psychotherapy and sexual hormone substitution compared to V3 (day1) the intervention group vs. the group with psychotherapy alone

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    End point title
    Change of the neuropsychological performance measured by go/no-go test: CE after 10 weeks of psychotherapy and sexual hormone substitution compared to V3 (day1) the intervention group vs. the group with psychotherapy alone
    End point description
    Food-shift: Verum: 3.25 +/- 2.22; Placebo: 2.60 +/- 2.30 Food-nonshift: Verum: 1.25 +/- 1.26; Placebo:2.8 +/- 1.64 Neutral-shift: Verum: 3.75 +/- 1.89; Placebo: 7.60 +/- 2.07 Neutral-nonshift: see below
    End point type
    Primary
    End point timeframe
    visit 7 (day 113 +/- 7 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    4
    5
    Units: unit(s)
        arithmetic mean (standard deviation)
    3.75 ( 1.89 )
    3.80 ( 1.64 )
    Statistical analysis title
    go/no-go test: Commission errors (CE)
    Comparison groups
    Placebo group v Verum Group
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.38 [6]
    Method
    ANOVA
    Confidence interval
    Notes
    [6] - rm ANOVA with 3 rm factors (category: Food vs. neutral; shift-Status: shift vs. non-shift; time: V3/V6/V7); significant main effect for shift Status (p<0.001); significant main effect for category (p=0.005); no main effect for time (p= 0.15) or group

    Secondary: change in scores of subscales "eating concern", "weight concern" and "shape concern" measured by the EDE-Q

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    End point title
    change in scores of subscales "eating concern", "weight concern" and "shape concern" measured by the EDE-Q
    End point description
    End point type
    Secondary
    End point timeframe
    visit 7 (day 113 +/- 7 days)
    End point values
    Verum group II Placebo Group II
    Number of subjects analysed
    4
    3
    Units: unit(s)
        arithmetic mean (standard deviation)
    2.06 ( 1.38 )
    1.44 ( 1.11 )
    Statistical analysis title
    EDE-Q
    Statistical analysis description
    Change in EDE-Q between V3, V6 and V7 compared between Verum Group and Placebo group
    Comparison groups
    Verum group II v Placebo Group II
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.87 [7]
    Method
    ANOVA
    Confidence interval
    Notes
    [7] - rm-ANOVA with 1 rm factor (V3/V6/V7), EDE-Q as dependent variable and Group as between-subject factor

    Secondary: change in psychopathology measured by EDI-2

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    End point title
    change in psychopathology measured by EDI-2
    End point description
    End point type
    Secondary
    End point timeframe
    visit 7 (day 113 +/- 7 days)
    End point values
    Verum group II Placebo Group II
    Number of subjects analysed
    4
    3
    Units: unit(s)
        arithmetic mean (standard deviation)
    277.00 ( 64.08 )
    263.67 ( 115.24 )
    Statistical analysis title
    EDI-2
    Statistical analysis description
    Change in EDI-2 between V3, V6 and V7 compared between Verum Group and Placebo group
    Comparison groups
    Verum group II v Placebo Group II
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.93 [8]
    Method
    ANOVA
    Confidence interval
    Notes
    [8] - rm-ANOVA with 1 rm factor (V3/V6/V7), EDE-Q as dependent variable and Group as between-subject factor.

    Secondary: change in state anxiety measured by STAI state

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    End point title
    change in state anxiety measured by STAI state
    End point description
    End point type
    Secondary
    End point timeframe
    visit 7 (day 113 +/- 7 days)
    End point values
    Verum group II Placebo Group II
    Number of subjects analysed
    4
    3
    Units: unit(s)
        arithmetic mean (standard deviation)
    48.00 ( 13.37 )
    44.67 ( 16.62 )
    Statistical analysis title
    STAI state
    Statistical analysis description
    Change in STAI state between V3, V6 and V7 compared between Verum Group and Placebo group
    Comparison groups
    Verum group II v Placebo Group II
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.58 [9]
    Method
    ANOVA
    Confidence interval
    Notes
    [9] - rm ANOVA with 1 rm factor (V3/V6/V7), STAI state as Independent variable and Group as between-subject factor.

    Secondary: change in depressive co-morbidity measured by PHQ-9

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    End point title
    change in depressive co-morbidity measured by PHQ-9
    End point description
    End point type
    Secondary
    End point timeframe
    visit 7 (day 113 +/- 7 days)
    End point values
    Verum group II Placebo Group II
    Number of subjects analysed
    4
    3
    Units: unit(s)
        arithmetic mean (standard deviation)
    0.25 ( 0.50 )
    0.33 ( 0.58 )
    Statistical analysis title
    PHQ-9
    Comparison groups
    Verum group II v Placebo Group II
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.88 [10]
    Method
    ANOVA
    Confidence interval
    Notes
    [10] - rm ANOVA with 1 factor (V3/V6/V7), PHQ-9 as Independent variable and Group as between-subject factor

    Secondary: change in quality of life associated with eating disorders measured by EDQoL

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    End point title
    change in quality of life associated with eating disorders measured by EDQoL
    End point description
    End point type
    Secondary
    End point timeframe
    visit 7 (day 113 +/- 7 days)
    End point values
    Verum group II Placebo Group II
    Number of subjects analysed
    4
    3
    Units: unit(s)
        arithmetic mean (standard deviation)
    23.25 ( 18.25 )
    14.00 ( 11.27 )
    Statistical analysis title
    EDQoL
    Comparison groups
    Verum group II v Placebo Group II
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.84 [11]
    Method
    ANOVA
    Confidence interval
    Notes
    [11] - rm ANOVA with 1 rm factor (V3/V6/V7), EDQoL as Independent variable an dgroup as between-subject factor

    Secondary: change of plasma cortisol levels during a dexamethason suppression test

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    End point title
    change of plasma cortisol levels during a dexamethason suppression test
    End point description
    End point type
    Secondary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    3 [12]
    4 [13]
    Units: unit(s)
        arithmetic mean (standard deviation)
    36.92 ( 9.64 )
    70.66 ( 85.54 )
    Notes
    [12] - in one subject no values available
    [13] - in one subject no values available
    Statistical analysis title
    Cortisol
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.36 [14]
    Method
    ANOVA
    Confidence interval
    Notes
    [14] - rm ANOVA with 1 rm factor (time), Cortisol concentrations as dependent variable and Group as between-subject factor.

    Secondary: change of sexual hormone plasma levels: LH

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    End point title
    change of sexual hormone plasma levels: LH
    End point description
    End point type
    Secondary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    3 [15]
    3 [16]
    Units: Unit(s)/litre
        arithmetic mean (standard deviation)
    0.11 ( 0.19 )
    3.34 ( 2.93 )
    Notes
    [15] - in one subject no values available
    [16] - in two subjects no values available
    Statistical analysis title
    LH
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.28 [17]
    Method
    ANOVA
    Confidence interval
    Notes
    [17] - rm ANOVA with 1 rm factor (time), LH as dependent variable and Group as between-subject factor

    Secondary: change of plasma levels of appetite-regulating peptids: Ghrelin

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    End point title
    change of plasma levels of appetite-regulating peptids: Ghrelin
    End point description
    0 min: Verum: 432.96 +/- 188.20; Placebo: 762.79 +/- 241.07 30 min: Verum: 342.58 +/- 174.46; Placebo: 700.78 +/- 301.00 60 min: Verum: 281.27 +/- 148.63; Placebo: 636.42 +/- 255.08 90 min: Verum: 291.24 +/- 153.63; Placebo: 642.78 +/- 270.31 120 min: see below
    End point type
    Secondary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    3 [18]
    4 [19]
    Units: unit(s)
        arithmetic mean (standard deviation)
    320.11 ( 138.06 )
    691.18 ( 271.94 )
    Notes
    [18] - in one subject no values available
    [19] - in one subject no values available
    Statistical analysis title
    Ghrelin-OGTT
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.07 [20]
    Method
    ANOVA
    Confidence interval
    Notes
    [20] - rm ANOVA with 2 rm factors (OGTT time Points; time pre/post), Ghrelin concentrations as dependent variable and Group as between-subject factor

    Secondary: number of AE

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    End point title
    number of AE
    End point description
    End point type
    Secondary
    End point timeframe
    from visit 3 (day 1) to visit 7 (day 113 +/- 7 days)
    End point values
    Verum Control
    Number of subjects analysed
    6
    5
    Units: whole numbers >/= 0
    6
    5
    No statistical analyses for this end point

    Secondary: Change in trait anxiety measured by STAI trait

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    End point title
    Change in trait anxiety measured by STAI trait
    End point description
    End point type
    Secondary
    End point timeframe
    visit 7 (day 113 +/- 7 days)
    End point values
    Verum group II Placebo Group II
    Number of subjects analysed
    4
    3
    Units: unit(s)
        arithmetic mean (standard deviation)
    48.50 ( 15.16 )
    42.67 ( 18.77 )
    Statistical analysis title
    STAI trait
    Statistical analysis description
    Change in STAI trait between V3, V6 and V7 compared between Verum Group and Placebo group
    Comparison groups
    Verum group II v Placebo Group II
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.66 [21]
    Method
    ANOVA
    Confidence interval
    Notes
    [21] - rm ANOVA with 1 factor (V3/V6/V7), STAI trait as Independent variable and Group as between-subject factor.

    Secondary: change of sexual hormone plasma levels: FSH

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    End point title
    change of sexual hormone plasma levels: FSH
    End point description
    End point type
    Secondary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    3 [22]
    3 [23]
    Units: Unit(s)/litre
        arithmetic mean (standard deviation)
    0.17 ( 0.29 )
    3.48 ( 2.63 )
    Notes
    [22] - In one subject value missing
    [23] - In two subjects value missing
    Statistical analysis title
    FSH
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.14 [24]
    Method
    ANOVA
    Confidence interval
    Notes
    [24] - rm ANOVA with 1 rm factor (time), FSH as dependent variable and Group as between-subject factor.

    Secondary: change of sexual hormone plasma levels: Estradiol

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    End point title
    change of sexual hormone plasma levels: Estradiol
    End point description
    End point type
    Secondary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    3 [25]
    3 [26]
    Units: nanogram(s)/litre
        arithmetic mean (standard deviation)
    0 ( 0 )
    42.25 ( 55.05 )
    Notes
    [25] - in one subject no value available
    [26] - in two subjects no value available
    Statistical analysis title
    Estradiol
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.53 [27]
    Method
    ANOVA
    Confidence interval
    Notes
    [27] - rm ANOVA with 1 rm factor (time), estradiol as dependent variable and Group as between-subject factor.

    Secondary: change of sexual hormone plasma levels: Testosteron

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    End point title
    change of sexual hormone plasma levels: Testosteron
    End point description
    End point type
    Secondary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    3 [28]
    3 [29]
    Units: microgram(s)/litre
        arithmetic mean (standard deviation)
    0.16 ( 0.07 )
    0.13 ( 0.05 )
    Notes
    [28] - in one subject no value available
    [29] - in two subjects no value available
    Statistical analysis title
    Testosteron
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.28 [30]
    Method
    ANOVA
    Confidence interval
    Notes
    [30] - rm ANOVA with 1 rm factor (time), Testosteron as dependent variable and Group as between-subject factor

    Secondary: change of plasma levels of appetite-regulating peptids: Leptin

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    End point title
    change of plasma levels of appetite-regulating peptids: Leptin
    End point description
    0 min: Verum: 21.84 +/- 11.15; Placebo: 3.33 +/- 2.72 30 min: Verum: 18.99 +/- 5.38; Placebo: 2.99 +/- 2.34 60 min: Verum: 15.49 +/- 6.38; Placebo: 3.08 +/- 2.68 90 min: Verum: 18.60 +/- 7.84; Placebo: 2.95 +/- 2.50 120 min: see below
    End point type
    Secondary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    3 [31]
    4 [32]
    Units: unit(s)
        arithmetic mean (standard deviation)
    19.13 ( 9.61 )
    3.45 ( 3.27 )
    Notes
    [31] - in one subject no values available
    [32] - in one subject no values available
    Statistical analysis title
    Leptin-OGTT
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.016 [33]
    Method
    ANOVA
    Confidence interval
    Notes
    [33] - rm ANOVA with 2 rm factors (OGTT time Points and pre/post), Leptin concentrations as dependent variable and Group as between-subject factor

    Secondary: change of plasma levels of Insulin

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    End point title
    change of plasma levels of Insulin
    End point description
    0 min: Verum: 11.39 +/- 4.67; Placebo: 6.45 +/- 3.57 30 min: Verum: 79.66 +/- 45.12; Placebo: 48.38 +/- 21.61 60 min: Verum: 88.00 +/- 33.64; Placebo: 42.91 +/- 19.23 90 min: Verum: 91.46 +/- 55.16; Placebo: 44.73 +/- 25.84 120 min: see below
    End point type
    Secondary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    3 [34]
    4 [35]
    Units: unit(s)
        arithmetic mean (standard deviation)
    79.56 ( 26.29 )
    21.91 ( 12.69 )
    Notes
    [34] - in one subject no values available
    [35] - in one subject no values available
    Statistical analysis title
    Insulin-OGTT
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.44 [36]
    Method
    ANOVA
    Confidence interval
    Notes
    [36] - rm ANOVA with 2 rm factors (time Point of the OGTT and pre/post), Insulin concentrations as the dependent variable and Group as between-subject factor.

    Secondary: change of plasma levels of Glucose

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    End point title
    change of plasma levels of Glucose
    End point description
    0 min: Verum: 107.19 +/- 21.59; Placebo: 84.37 +/- 11.28 30 min: Verum: 178.20 +/- 64.42; Placebo: 125.20 +/- 25.07 60 min: Verum: 152.73 +/- 46.07; Placebo: 107.54 +/- 55.02 90 min: Verum: 131.09 +/- 29.29; Placebo: 90.04 +/- 32.33 120 min: see below
    End point type
    Secondary
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    3 [37]
    4 [38]
    Units: unit(s)
        arithmetic mean (standard deviation)
    122.36 ( 31.26 )
    77.64 ( 16.96 )
    Notes
    [37] - in one subject no values available
    [38] - in one subject no values available
    Statistical analysis title
    Glucose-OGTT
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.44 [39]
    Method
    ANOVA
    Confidence interval
    Notes
    [39] - rm ANOVA with 2 rm factors (OGTT time Points and pre/post), Glucose concentration as dependent variable and Group as between-subject factor.

    Other pre-specified: Change in BMI

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    End point title
    Change in BMI
    End point description
    End point type
    Other pre-specified
    End point timeframe
    visit 6 (day 73 +/- 3 days)
    End point values
    Verum Group Placebo group
    Number of subjects analysed
    4
    5
    Units: kg/m2
        arithmetic mean (standard deviation)
    18.45 ( 1.59 )
    17.66 ( 1.97 )
    Statistical analysis title
    BMI
    Comparison groups
    Verum Group v Placebo group
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.49 [40]
    Method
    ANOVA
    Confidence interval
    Notes
    [40] - rm ANOVA with 1 rm factor (time); significant main effect for time (p=0.023), no main effect for group

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    visit 3 (day 1) to visit 7 (day 113 +/- 7 days)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Verum
    Reporting group description
    -

    Reporting group title
    Control
    Reporting group description
    -

    Serious adverse events
    Verum Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Oesophagitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Verum Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
    3 / 5 (60.00%)
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Foot fracture
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    2

    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.
    Early Termination due to poor recruitment, therefore no reliable statistical analyses could be performed

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/29631553
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