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    Clinical Trial Results:
    Karisma Pilot: A randomized, open pilot study to investigate the mammographic density reduction in healthy women ,within the Karma cohort, for two different doses of tamoxifen.

    Summary
    EudraCT number
    2014-005005-20
    Trial protocol
    SE  
    Global end of trial date
    03 Feb 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Mar 2023
    First version publication date
    16 Mar 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2014-005005-20
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04079517
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Karolinska Institutet
    Sponsor organisation address
    Nobels väg 6, Solna, Sweden, 17177
    Public contact
    Per Hall, Södersjukhuset, Karma Study Center Karolinska Institutet, 0046 +4670750 2110, per.hall@ki.se
    Scientific contact
    Per Hall, Södersjukhuset, Karma Study Center Karolinska Institutet, 0046 +4670750 2110, per.hall@ki.se
    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 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective: To identify time to mammographic density change in healthy women using two different doses of tamoxifen.
    Protection of trial subjects
    Side effects were reported in a structured questionnaire at baseline and months 3, 6, and 9.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Mar 2015
    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
    Sweden: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    32
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 723 participants of the Karma cohort, a prospective screening cohort,8 were invited when they attended their biannual screening mammography.

    Pre-assignment
    Screening details
    Out of 723 invited 56 (7.7%) women were willing to participate, 14 did not fulfill exclusion/inclusion criteria and 42 (5.8%) were finally included.

    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
    10 mg of tamoxifen
    Arm description
    This arm studied the side effects, adherence and a possible difference in effect after exposure to 10 mg of tamoxifen.
    Arm type
    Experimental

    Investigational medicinal product name
    TAMOXIFEN
    Investigational medicinal product code
    SUB10825MIG
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily doses, 10 mg, of tamoxifen for 6 months.

    Arm title
    20 mg of tamoxifen
    Arm description
    This arm studied the side effects, adherence and a possible difference in effect after exposure to 20 mg of tamoxifen.
    Arm type
    Active comparator

    Investigational medicinal product name
    TAMOXIFEN
    Investigational medicinal product code
    SUB10825MIG
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily doses, 20 mg, of tamoxifen for 6 months.

    Number of subjects in period 1
    10 mg of tamoxifen 20 mg of tamoxifen
    Started
    23
    19
    Completed
    18
    15
    Not completed
    5
    4
         Adverse event, non-fatal
    5
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    10 mg of tamoxifen
    Reporting group description
    This arm studied the side effects, adherence and a possible difference in effect after exposure to 10 mg of tamoxifen.

    Reporting group title
    20 mg of tamoxifen
    Reporting group description
    This arm studied the side effects, adherence and a possible difference in effect after exposure to 20 mg of tamoxifen.

    Reporting group values
    10 mg of tamoxifen 20 mg of tamoxifen Total
    Number of subjects
    23 19 42
    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)
    59.74 ± 8.48 62.32 ± 6.74 -
    Gender categorical
    Units: Subjects
        Female
    23 19 42
    Postmenopausal
    Number of women who are premenopausal and postmenopausal.
    Units: Subjects
        Postmenopausal
    16 15 31
        Premonopausal
    7 4 11

    End points

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    End points reporting groups
    Reporting group title
    10 mg of tamoxifen
    Reporting group description
    This arm studied the side effects, adherence and a possible difference in effect after exposure to 10 mg of tamoxifen.

    Reporting group title
    20 mg of tamoxifen
    Reporting group description
    This arm studied the side effects, adherence and a possible difference in effect after exposure to 20 mg of tamoxifen.

    Primary: Change in mammographic density at 3 months following start of two different doses of tamoxifen

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    End point title
    Change in mammographic density at 3 months following start of two different doses of tamoxifen
    End point description
    Average changes of mammographic density at 3 months compared to baseline were calculated with 95% confidence intervals.
    End point type
    Primary
    End point timeframe
    3 months compared to baseline.
    End point values
    10 mg of tamoxifen 20 mg of tamoxifen
    Number of subjects analysed
    19
    14
    Units: percent
        arithmetic mean (confidence interval 95%)
    -2.1 (-4.2 to -0.1)
    -1.3 (-3.7 to -1.1)
    Statistical analysis title
    Changes in mammographic density at 3 months
    Statistical analysis description
    Average changes of mammographic density at 3 months, compared to baseline, were calculated a with 95% confidence intervals.
    Comparison groups
    10 mg of tamoxifen v 20 mg of tamoxifen
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    > 0.05
    Method
    t-test, 2-sided
    Confidence interval

    Primary: Change in mammographic density at 6 months, following start of two different doses of tamoxifen

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    End point title
    Change in mammographic density at 6 months, following start of two different doses of tamoxifen
    End point description
    Average changes of mammographic density at 6 months, compared to baseline, were calculated a with 95% confidence intervals.
    End point type
    Primary
    End point timeframe
    6 months compared to baseline.
    End point values
    10 mg of tamoxifen 20 mg of tamoxifen
    Number of subjects analysed
    19
    14
    Units: percent
        arithmetic mean (confidence interval 95%)
    -3.1 (-5.7 to -0.5)
    -1.0 (-4.1 to 2.0)
    Statistical analysis title
    Changes in mammographic density at 6 months
    Statistical analysis description
    Average changes of mammographic density at 6 months, compared to baseline, were calculated a with 95% confidence intervals.
    Comparison groups
    10 mg of tamoxifen v 20 mg of tamoxifen
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    > 0.05
    Method
    t-test, 2-sided
    Confidence interval

    Primary: Change in mammographic density at 9 months, following start of two different doses of tamoxifen

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    End point title
    Change in mammographic density at 9 months, following start of two different doses of tamoxifen
    End point description
    End point type
    Primary
    End point timeframe
    9 months compared to baseline.
    End point values
    10 mg of tamoxifen 20 mg of tamoxifen
    Number of subjects analysed
    19
    14
    Units: percent
        arithmetic mean (confidence interval 95%)
    -3.3 (-6.1 to -0.5)
    -2.5 (-5.7 to 0.8)
    Statistical analysis title
    Changes in mammographic density at 9 months
    Statistical analysis description
    Average changes of mammographic density at 9 months, compared to baseline, were calculated a with 95% confidence intervals.
    Comparison groups
    10 mg of tamoxifen v 20 mg of tamoxifen
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    > 0.05
    Method
    t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During intake of IMP plus 1 month.
    Adverse event reporting additional description
    A total of 911 symptom reports were registered but no serious adverse event was seen.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    10 mg of tamoxifen
    Reporting group description
    This arm studied the side effects, adherence and a possible difference in effect after exposure to 10 mg of tamoxifen.

    Reporting group title
    20 mg of tamoxifen
    Reporting group description
    This arm studied the side effects, adherence and a possible difference in effect after exposure to 20 mg of tamoxifen.

    Serious adverse events
    10 mg of tamoxifen 20 mg of tamoxifen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 19 (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: 2%
    Non-serious adverse events
    10 mg of tamoxifen 20 mg of tamoxifen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 23 (78.26%)
    18 / 19 (94.74%)
    Nervous system disorders
    Numbness/tingling in the hands and feet
         subjects affected / exposed
    3 / 23 (13.04%)
    5 / 19 (26.32%)
         occurrences all number
    3
    5
    Mood swings
         subjects affected / exposed
    6 / 23 (26.09%)
    6 / 19 (31.58%)
         occurrences all number
    6
    6
    Headache
         subjects affected / exposed
    10 / 23 (43.48%)
    9 / 19 (47.37%)
         occurrences all number
    10
    9
    Concentration ability impaired
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    Feeling sad
         subjects affected / exposed
    3 / 23 (13.04%)
    5 / 19 (26.32%)
         occurrences all number
    3
    5
    Irritability
         subjects affected / exposed
    5 / 23 (21.74%)
    7 / 19 (36.84%)
         occurrences all number
    5
    7
    Lack of energy
         subjects affected / exposed
    6 / 23 (26.09%)
    7 / 19 (36.84%)
         occurrences all number
    6
    7
    Worry
         subjects affected / exposed
    7 / 23 (30.43%)
    6 / 19 (31.58%)
         occurrences all number
    7
    6
    Eyesight changes
         subjects affected / exposed
    6 / 23 (26.09%)
    8 / 19 (42.11%)
         occurrences all number
    6
    8
    Difficulty sleeping
         subjects affected / exposed
    11 / 23 (47.83%)
    9 / 19 (47.37%)
         occurrences all number
    11
    9
    Feel lightheaded (dizzy)
         subjects affected / exposed
    4 / 23 (17.39%)
    4 / 19 (21.05%)
         occurrences all number
    4
    4
    Reproductive system and breast disorders
    Vaginal bleeding or spotting
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Vaginal discharge
         subjects affected / exposed
    7 / 23 (30.43%)
    11 / 19 (57.89%)
         occurrences all number
    7
    11
    Sexual feeling decreased
         subjects affected / exposed
    9 / 23 (39.13%)
    10 / 19 (52.63%)
         occurrences all number
    9
    10
    Vaginal itching/irritation
         subjects affected / exposed
    3 / 23 (13.04%)
    5 / 19 (26.32%)
         occurrences all number
    3
    5
    Pain from breast tissue or breast skin
         subjects affected / exposed
    4 / 23 (17.39%)
    5 / 19 (26.32%)
         occurrences all number
    4
    5
    Fragile mucous membranes/ Mucous membrane disorder
         subjects affected / exposed
    7 / 23 (30.43%)
    10 / 19 (52.63%)
         occurrences all number
    7
    10
    Painful intercourse
         subjects affected / exposed
    4 / 23 (17.39%)
    5 / 19 (26.32%)
         occurrences all number
    4
    5
    Dryness vaginal
         subjects affected / exposed
    11 / 23 (47.83%)
    14 / 19 (73.68%)
         occurrences all number
    11
    14
    Skin and subcutaneous tissue disorders
    skin rashes
         subjects affected / exposed
    6 / 23 (26.09%)
    4 / 19 (21.05%)
         occurrences all number
    6
    4
    Hair loss
         subjects affected / exposed
    7 / 23 (30.43%)
    7 / 19 (36.84%)
         occurrences all number
    7
    7
    Itching
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 19 (0.00%)
         occurrences all number
    3
    0
    Renal and urinary disorders
    Problems with urination
         subjects affected / exposed
    2 / 23 (8.70%)
    3 / 19 (15.79%)
         occurrences all number
    2
    3
    Endocrine disorders
    Cold sweat
         subjects affected / exposed
    8 / 23 (34.78%)
    9 / 19 (47.37%)
         occurrences all number
    8
    9
    Night sweats
         subjects affected / exposed
    15 / 23 (65.22%)
    18 / 19 (94.74%)
         occurrences all number
    15
    18
    Menopausal hot flushes
         subjects affected / exposed
    14 / 23 (60.87%)
    17 / 19 (89.47%)
         occurrences all number
    14
    17
    Musculoskeletal and connective tissue disorders
    muscle cramps (e.g. in legs)
         subjects affected / exposed
    14 / 23 (60.87%)
    16 / 19 (84.21%)
         occurrences all number
    14
    16
    Pain in joints
         subjects affected / exposed
    12 / 23 (52.17%)
    11 / 19 (57.89%)
         occurrences all number
    12
    11
    Metabolism and nutrition disorders
    Diarrhoea
         subjects affected / exposed
    6 / 23 (26.09%)
    3 / 19 (15.79%)
         occurrences all number
    6
    3
    Constipation
         subjects affected / exposed
    4 / 23 (17.39%)
    5 / 19 (26.32%)
         occurrences all number
    4
    5
    weight gain
         subjects affected / exposed
    12 / 23 (52.17%)
    14 / 19 (73.68%)
         occurrences all number
    12
    14
    Nausea
         subjects affected / exposed
    7 / 23 (30.43%)
    6 / 19 (31.58%)
         occurrences all number
    7
    6
    Vomiting
         subjects affected / exposed
    12 / 23 (52.17%)
    13 / 19 (68.42%)
         occurrences all number
    12
    13

    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/35605013
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