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    Clinical Trial Results:
    An investigator-blinded, active-controlled phase 3 study to prove the non-inferior efficacy of a Clotrimazole ovule (500 mg) versus a Clotrimazole vaginal tablet (500 mg) in vaginal candidiasis

    Summary
    EudraCT number
    2008-000718-63
    Trial protocol
    DE  
    Global end of trial date
    27 May 2009

    Results information
    Results version number
    v2(current)
    This version publication date
    02 Sep 2016
    First version publication date
    15 Jul 2015
    Other versions
    v1
    Version creation reason
    • New data added to full data set
    • Correction of full data set
    Bayer sponsor contact information to be updated

    Trial information

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    Trial identification
    Sponsor protocol code
    13071
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00755053
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee , Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 May 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate non-inferior efficacy of a single dose of clotrimazole 500 milligram (mg) vaginal ovule compared to a single dose of clotrimazole 500 mg vaginal tablet at visit 2 (10-14 days post-application), in terms of overall response defined as clinical cure and mycological cure.
    Protection of trial subjects
    All clinical work conducted in this study was subjected to the rules of Good Clinical Practice (GCP) and under the guidelines of Declaration of Helsinki. These practices include the following areas: Institutional review board (IRB)/Independent Ethics Committee procedures, informed consent, protocol adherence, administrative documents, drug supply accountability, data collection, subject records (source documents), adverse event (AE) recording and reporting, inspection and records retention. The subjects’ records were kept confidential and were insured by the sponsor.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    18 Sep 2008
    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: 240
    Country: Number of subjects enrolled
    Russian Federation: 225
    Worldwide total number of subjects
    465
    EEA total number of subjects
    240
    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)
    16
    Adults (18-64 years)
    449
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study was conducted between 18 September 2008 and 27 May 2009 at 18 centers from 2 countries; Germany (11 centers) and Russia (7 centers).

    Pre-assignment
    Screening details
    At screening/baseline, clinical symptoms (itching, burning/irritation, discharge, dysuria) and signs (vaginal edema, erythema and excoriation, and vulval edema, erythema and excoriation) of vaginitis were assessed and a mycological testing was performed.

    Period 1
    Period 1 title
    Baseline period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Investigator [1]
    Blinding implementation details
    Packages distributed to the subjects were not distinguished by the investigator. Only the randomization code for each subject was supplied to each investigator in sealed envelopes. The code was kept in a secure place at the study sites and at the sponsor. The code was only to be broken in case of an emergency. Once all data had been quality controlled and the data were accepted for final analysis after the blind data meeting, the database was locked and the randomization code was broken.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Clotrimazole tablet (Canesten, BAY-B5097)
    Arm description
    Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
    Arm type
    Active comparator

    Investigational medicinal product name
    Clotrimazole
    Investigational medicinal product code
    BAY-B5097
    Other name
    Canesten
    Pharmaceutical forms
    Vaginal tablet
    Routes of administration
    Vaginal use
    Dosage and administration details
    Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).

    Arm title
    Clotrimazole ovule (Canesten, BAY-B5097)
    Arm description
    Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
    Arm type
    Experimental

    Investigational medicinal product name
    Clotrimazole
    Investigational medicinal product code
    BAY-B5097
    Other name
    Canesten
    Pharmaceutical forms
    Suppository
    Routes of administration
    Vaginal use
    Dosage and administration details
    Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Study medication could not be blinded, therefore an investigatorblinded design was chosen in order not to bias the clinical evaluation of symptoms and signs.
    Number of subjects in period 1 [2]
    Clotrimazole tablet (Canesten, BAY-B5097) Clotrimazole ovule (Canesten, BAY-B5097)
    Started
    228
    235
    Completed
    228
    235
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Not all the enrolled subjects were treated with study drugs. As baseline only included treated subjects, the worldwide number enrolled in the trial differs with the number of subjects reported in the baseline period.
    Period 2
    Period 2 title
    Overall trial
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Investigator [3]
    Blinding implementation details
    Packages distributed to the subjects were not distinguished by the investigator. Only the randomization code for each subject was supplied to each investigator in sealed envelopes. The code was kept in a secure place at the study sites and at the sponsor. The code was only to be broken in case of an emergency. Once all data had been quality controlled and the data were accepted for final analysis after the blind data meeting, the database was locked and the randomization code was broken.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Clotrimazole tablet (Canesten, BAY-B5097)
    Arm description
    Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
    Arm type
    Active comparator

    Investigational medicinal product name
    Clotrimazole
    Investigational medicinal product code
    BAY-B5097
    Other name
    Canesten
    Pharmaceutical forms
    Vaginal tablet
    Routes of administration
    Vaginal use
    Dosage and administration details
    Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).

    Arm title
    Clotrimazole ovule (Canesten, BAY-B5097)
    Arm description
    Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
    Arm type
    Experimental

    Investigational medicinal product name
    Clotrimazole
    Investigational medicinal product code
    BAY-B5097
    Other name
    Canesten
    Pharmaceutical forms
    Suppository
    Routes of administration
    Vaginal use
    Dosage and administration details
    Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).

    Notes
    [3] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Study medication could not be blinded, therefore an investigatorblinded design was chosen in order not to bias the clinical evaluation of symptoms and signs.
    Number of subjects in period 2
    Clotrimazole tablet (Canesten, BAY-B5097) Clotrimazole ovule (Canesten, BAY-B5097)
    Started
    228
    237
    Treated
    228
    235
    Completed
    176
    172
    Not completed
    52
    65
         Protocol deviation
    1
    5
         Other-Unspecified
    7
    6
         Diagnosis of candidasis not confirmed
    33
    45
         Adverse event, non-fatal
    3
    3
         Lost to follow-up
    8
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Clotrimazole tablet (Canesten, BAY-B5097)
    Reporting group description
    Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).

    Reporting group title
    Clotrimazole ovule (Canesten, BAY-B5097)
    Reporting group description
    Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).

    Reporting group values
    Clotrimazole tablet (Canesten, BAY-B5097) Clotrimazole ovule (Canesten, BAY-B5097) Total
    Number of subjects
    228 235 463
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    8 8 16
        Adults (18-64 years)
    220 227 447
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    31.7 ± 8.5 30.5 ± 8 -
    Gender categorical
    Units: Subjects
        Female
    228 235 463
        Male
    0 0 0
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received a dose of the trial medication.

    Subject analysis set title
    Intent-to-treat population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All subjects who completed the treatment and at least visit 2 (10-14 days post-application) with a positive mycological test result for Candida at baseline.

    Subject analysis set title
    Per-protocol population
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All subjects who completed the treatment and at least visit 2 (10-14 days post-application), with a positive mycological test result for Candida at baseline but without a major protocol violations.

    Subject analysis sets values
    Safety population Intent-to-treat population Per-protocol population
    Number of subjects
    463
    377
    366
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    16
    14
    14
        Adults (18-64 years)
    447
    363
    352
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    31.1 ± 8.3
    31.4 ± 8.3
    31.4 ± 8.3
    Gender categorical
    Units: Subjects
        Female
    463
    377
    366
        Male
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Clotrimazole tablet (Canesten, BAY-B5097)
    Reporting group description
    Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).

    Reporting group title
    Clotrimazole ovule (Canesten, BAY-B5097)
    Reporting group description
    Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
    Reporting group title
    Clotrimazole tablet (Canesten, BAY-B5097)
    Reporting group description
    Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).

    Reporting group title
    Clotrimazole ovule (Canesten, BAY-B5097)
    Reporting group description
    Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).

    Subject analysis set title
    Safety population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received a dose of the trial medication.

    Subject analysis set title
    Intent-to-treat population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All subjects who completed the treatment and at least visit 2 (10-14 days post-application) with a positive mycological test result for Candida at baseline.

    Subject analysis set title
    Per-protocol population
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All subjects who completed the treatment and at least visit 2 (10-14 days post-application), with a positive mycological test result for Candida at baseline but without a major protocol violations.

    Primary: Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)

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    End point title
    Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)
    End point description
    Overall response was defined as clinical cure and mycological cure. Mycological cure was defined as negative microscopy and negative mycological culture and a clinical cure was defined as absence of the symptoms itching and burning/ irritation, and no more than mild expressions of other symptoms and signs, and no worsening of any symptoms and signs compared to the baseline visit.
    End point type
    Primary
    End point timeframe
    Day 10 up to 14
    End point values
    Clotrimazole tablet (Canesten, BAY-B5097) Clotrimazole ovule (Canesten, BAY-B5097)
    Number of subjects analysed
    186 [1]
    180 [2]
    Units: Percentage of subjects
        number (confidence interval 95%)
    66.1 (59.1 to 73.2)
    73.3 (66.6 to 80.1)
    Notes
    [1] - Per-Protocol population was used for analysis.
    [2] - Per-Protocol population was used for analysis.
    Statistical analysis title
    Ovule versus Tablet
    Statistical analysis description
    Difference in treatment groups was expressed as percentage along with 95% Confidence Interval (CI).
    Comparison groups
    Clotrimazole tablet (Canesten, BAY-B5097) v Clotrimazole ovule (Canesten, BAY-B5097)
    Number of subjects included in analysis
    366
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.33
    Method
    Fisher exact
    Parameter type
    Percentage difference
    Point estimate
    7.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.3
         upper limit
    21.7

    Secondary: Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)

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    End point title
    Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)
    End point description
    Overall response was defined as clinical cure and mycological cure, mycological cure was defined as negative microscopy and negative mycological culture and a clinical cure was defined as absence of the symptoms itching and burning/ irritation, and no more than mild expressions of other symptoms and signs, and no worsening of any symptoms and signs compared to the baseline visit.
    End point type
    Secondary
    End point timeframe
    Week 6 up to 8
    End point values
    Clotrimazole tablet (Canesten, BAY-B5097) Clotrimazole ovule (Canesten, BAY-B5097)
    Number of subjects analysed
    169 [3]
    169 [4]
    Units: percentage of subjects
        number (confidence interval 95%)
    75.7 (69 to 82.5)
    73.4 (66.4 to 80.3)
    Notes
    [3] - Per Protocol Population with available data only, was used for anaylsis.
    [4] - Per Protocol Population with available data only, was used for anaylsis.
    Statistical analysis title
    Ovule versus Tablet
    Statistical analysis description
    Difference in treatment groups was expressed as percentage along with 95% CI.
    Comparison groups
    Clotrimazole ovule (Canesten, BAY-B5097) v Clotrimazole tablet (Canesten, BAY-B5097)
    Number of subjects included in analysis
    338
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.75
    Method
    Fisher exact
    Parameter type
    Percentage difference
    Point estimate
    -2.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -17
         upper limit
    12.2

    Secondary: Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)

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    End point title
    Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)
    End point description
    Subjects with clinical cure (resolution of signs and symptoms of vaginitis) at Visit 2 (Day 10 to 14) by signs of vaginitis (vaginal edema, erythema and excoriation, and vulval edema, erythema and excoriation), symptoms of vaginitis (itching, burning/irritation, discharge, dysuria) and both signs and symptoms of vaginitis.
    End point type
    Secondary
    End point timeframe
    Day 10 up to 14
    End point values
    Clotrimazole tablet (Canesten, BAY-B5097) Clotrimazole ovule (Canesten, BAY-B5097)
    Number of subjects analysed
    186 [5]
    180 [6]
    Units: percentage of subjects
    number (confidence interval 95%)
        Clinical Symptoms
    84.9 (79.5 to 90.4)
    88.9 (84 to 93.8)
        Clinical Signs
    97.3 (94.7 to 99.9)
    98.9 (97.1 to 100.7)
    Notes
    [5] - Per Protocol Population with available data only, was used for anaylsis.
    [6] - Per Protocol Population with available data only, was used for anaylsis.
    Statistical analysis title
    Ovule versus tablet for clinical symptoms
    Statistical analysis description
    Difference in treatment groups was expressed as percentage along with 95% CI.
    Comparison groups
    Clotrimazole tablet (Canesten, BAY-B5097) v Clotrimazole ovule (Canesten, BAY-B5097)
    Number of subjects included in analysis
    366
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Percentage difference
    Point estimate
    3.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.1
         upper limit
    15.9
    Statistical analysis title
    Ovule versus tablet for signs of vaginitis
    Statistical analysis description
    Difference in treatment groups was expressed as percentage along with 95% CI.
    Comparison groups
    Clotrimazole tablet (Canesten, BAY-B5097) v Clotrimazole ovule (Canesten, BAY-B5097)
    Number of subjects included in analysis
    366
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Percentage difference
    Point estimate
    1.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.3
         upper limit
    9.4

    Secondary: Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)

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    End point title
    Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)
    End point description
    Subjects with clinical cure (resolution of signs and symptoms of vaginitis) at Visit 2 (Day 10 to 14) by signs of vaginitis (vaginal edema, erythema and excoriation, and vulval edema, erythema and excoriation), symptoms of vaginitis (itching, burning/irritation, discharge, dysuria) and both signs and symptoms of vaginitis.
    End point type
    Secondary
    End point timeframe
    Week 6 up to 8
    End point values
    Clotrimazole tablet (Canesten, BAY-B5097) Clotrimazole ovule (Canesten, BAY-B5097)
    Number of subjects analysed
    170 [7]
    170 [8]
    Units: percentage of subjects
    number (confidence interval 95%)
        Clinical Symptoms
    93.5 (89.5 to 97.5)
    92.9 (88.8 to 97.1)
        Clinical Signs
    98.8 (96.9 to 100.7)
    95.3 (91.8 to 98.8)
    Notes
    [7] - Per Protocol Population with available data only, was used for anaylsis.
    [8] - Per Protocol Population with available data only, was used for anaylsis.
    Statistical analysis title
    Ovule versus tablet for clinical symptoms
    Statistical analysis description
    Difference in treatment groups was expressed as percentage along with 95% CI.
    Comparison groups
    Clotrimazole tablet (Canesten, BAY-B5097) v Clotrimazole ovule (Canesten, BAY-B5097)
    Number of subjects included in analysis
    340
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Percentage difference
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.2
         upper limit
    10.1
    Statistical analysis title
    Ovule versus tablet for signs of vaginitis
    Statistical analysis description
    Difference in treatment groups was expressed as percentage along with 95% CI.
    Comparison groups
    Clotrimazole tablet (Canesten, BAY-B5097) v Clotrimazole ovule (Canesten, BAY-B5097)
    Number of subjects included in analysis
    340
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Percentage difference
    Point estimate
    -3.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.2
         upper limit
    5.2

    Secondary: Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)

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    End point title
    Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)
    End point description
    Subjects with mycological cure (negative microscopy and negative culture) of Candida spp. at Visit 2 (Day 10 to 14) were reported.
    End point type
    Secondary
    End point timeframe
    Day 10 up to 14
    End point values
    Clotrimazole tablet (Canesten, BAY-B5097) Clotrimazole ovule (Canesten, BAY-B5097)
    Number of subjects analysed
    186 [9]
    180 [10]
    Units: percentage of subjects
        number (confidence interval 95%)
    78.5 (72.3 to 84.7)
    81.7 (75.7 to 87.6)
    Notes
    [9] - Per Protocol Population with available data only, was used for anaylsis.
    [10] - Per Protocol Population with available data only, was used for anaylsis.
    Statistical analysis title
    Ovule versus tablet
    Statistical analysis description
    Difference in treatment groups was expressed as percentage along with 95% CI.
    Comparison groups
    Clotrimazole ovule (Canesten, BAY-B5097) v Clotrimazole tablet (Canesten, BAY-B5097)
    Number of subjects included in analysis
    366
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Percentage difference
    Point estimate
    3.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.1
         upper limit
    16.5

    Secondary: Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)

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    End point title
    Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)
    End point description
    Subjects with mycological cure (negative microscopy and negative culture) of Candida spp. at Visit 3 (Week 6 to 8).
    End point type
    Secondary
    End point timeframe
    Week 6 to 8
    End point values
    Clotrimazole tablet (Canesten, BAY-B5097) Clotrimazole ovule (Canesten, BAY-B5097)
    Number of subjects analysed
    170 [11]
    169 [12]
    Units: percentage of subjects
        number (confidence interval 95%)
    81.8 (75.7 to 87.9)
    78.1 (71.6 to 84.6)
    Notes
    [11] - Per Protocol Population with available data only, was used for anaylsis.
    [12] - Per Protocol Population with available data only, was used for anaylsis.
    Statistical analysis title
    Ovule versus tablet
    Statistical analysis description
    Difference in treatment groups was expressed as percentage along with 95% CI.
    Comparison groups
    Clotrimazole tablet (Canesten, BAY-B5097) v Clotrimazole ovule (Canesten, BAY-B5097)
    Number of subjects included in analysis
    339
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Percentage difference
    Point estimate
    -3.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -17.5
         upper limit
    10.2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline (Day 0) up to the end of study (Day 60).
    Adverse event reporting additional description
    Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Clotrimazole tablet (Canesten, BAY-B5097)
    Reporting group description
    Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).

    Reporting group title
    Clotrimazole ovule (Canesten, BAY-B5097)
    Reporting group description
    Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0)

    Serious adverse events
    Clotrimazole tablet (Canesten, BAY-B5097) Clotrimazole ovule (Canesten, BAY-B5097)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 235 (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
    Clotrimazole tablet (Canesten, BAY-B5097) Clotrimazole ovule (Canesten, BAY-B5097)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 228 (7.89%)
    17 / 235 (7.23%)
    Cardiac disorders
    Tachycardia paroxysmal
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 235 (0.43%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 235 (0.85%)
         occurrences all number
    1
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 228 (0.00%)
    4 / 235 (1.70%)
         occurrences all number
    0
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 235 (0.85%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 228 (2.19%)
    3 / 235 (1.28%)
         occurrences all number
    6
    3
    Abdominal pain lower
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 235 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 235 (0.43%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 235 (0.43%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 235 (0.43%)
         occurrences all number
    1
    1
    Toothache
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 235 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dyspareunia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 235 (0.00%)
         occurrences all number
    1
    0
    Metrorrhagia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 235 (0.43%)
         occurrences all number
    0
    1
    Ovarian cyst
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 235 (0.43%)
         occurrences all number
    0
    1
    Uterine cervical erosion
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 235 (0.00%)
         occurrences all number
    1
    0
    Vaginal haemorrhage
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 235 (0.00%)
         occurrences all number
    3
    0
    Vulvovaginal discomfort
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 235 (0.43%)
         occurrences all number
    0
    1
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 235 (0.43%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 235 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 235 (0.00%)
         occurrences all number
    1
    0
    Furuncle
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 235 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 235 (0.43%)
         occurrences all number
    0
    1
    Mycoplasma infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 235 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 235 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 235 (0.43%)
         occurrences all number
    0
    1
    Trichomoniasis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 235 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 235 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 235 (0.43%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Aug 2008
    Change of exclusion criteria due to harmonization with the summary of product characteristics and change of the microbiological methods to more specific procedures as utilized in the involved labs at Berlin and Moscow.

    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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