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    Clinical Trial Results:
    Assessment of the efficacy of POLYGYNAX® in the empirical treatment of infectious vaginitis International, multicentre, randomised, double-blind, parallel group study, comparative versus miconazole

    Summary
    EudraCT number
    		 2014-001759-22
    Trial protocol
    		 FR   CZ   SK  
    Global end of trial date
    25 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2018
    First version publication date
    15 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PGX401-11
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02515656
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratoire Innotech International
    Sponsor organisation address
    22 avenue Aristide Briand, ARCUEIL, France, 94111 Cedex
    Public contact
    Medical Affairs Department, Laboratoire Innotech International, 0033 146152800,
    Scientific contact
    Medical Affairs Department, Laboratoire Innotech International, 0033 146152800,
    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
    25 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to demonstrate the superior clinical efficacy of POLYGYNAX® at the End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any) compared to miconazole in the empirical treatment of infectious vaginitis
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 131
    Country: Number of subjects enrolled
    Czech Republic: 318
    Country: Number of subjects enrolled
    France: 148
    Country: Number of subjects enrolled
    Serbia: 61
    Worldwide total number of subjects
    658
    EEA total number of subjects
    597
    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)
    658
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: 07 Sep 2015 to 03 Aug 2016. Countries involved: France - Czech Republic - Slovakia - Serbia

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 658
    Number of subjects completed
    		 658

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Polygynax
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Polygynax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal capsule, soft
    Routes of administration
    Vaginal use
    Dosage and administration details
    Nystatin (100 000 IU) + Neomycin sulphate (35 000 IU) + Polymyxin B sulphate (35 000 IU). One vaginal capsule once daily for 12 consecutive days.

    Arm title
    		 Miconazole+Placebo
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Miconazole+Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal capsule, soft
    Routes of administration
    Vaginal use
    Dosage and administration details
    Miconazole nitrate (400mg) + Placebo One Miconazole capsule once daily for 3 consecutive days then one placebo capsule once daily for 9 consecutive days.

    Number of subjects in period 1
    		Polygynax Miconazole+Placebo
    Started
    326
    332
    Completed
    270
    261
    Not completed
    56
    71
         Consent withdrawn by subject
    1
    5
         Screening failure
    1
    -
         Adverse event, non-fatal
    1
    3
         Use of treatment not allowed
    -
    1
         Lost to follow-up
    -
    2
         Lack of efficacy
    25
    39
         STI detected from the first vaginal sample
    24
    19
         Final visit not done
    4
    2

    Baseline characteristics

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

    Reporting group title
    Miconazole+Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Polygynax Miconazole+Placebo Total
    Number of subjects
    		 326 332 658
    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)
    		 0 0 0
        Adults (18-64 years)
    		 326 332 658
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.26 ± 10.18 33.51 ± 9.97 -
    Gender categorical
    Units: Subjects
        Female
    		 326 332 658
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    FAS population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS population is defined as all randomised patients excluding (as allowed by ICH E9): • Patients who did not take at least one dose of the study medication • Patients who present an STI (trichomoniasis; gonococcal and chlamydial infections) detected from the vaginal sample taken before randomisation at the Baseline Visit (Visit 1 / D1). • Patients without post-randomisation data.

    Subject analysis set title
    PPS population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPS population consists of all patients of the FAS without any major protocol deviation. This is the set of patients who participated in the study as intended. Before locking the data base, the precise reasons for excluding patients from the PP data set were fully defined and documented during a blind review meeting.

    Subject analysis set title
    mPPS Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The mPPS population consists of all patients of the FAS without any major protocol deviation except deviations about randomization process. This population was used for an additional sensitivity analysis on the PPS to document the influence of including or excluding these patients with deviations from the randomisation schedule.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SS population comprises all enrolled patients in the study, who have been administered at least one capsule of study drug.

    Subject analysis sets values
    		 FAS population PPS population mPPS Population Safety Population
    Number of subjects
    611
    552
    585
    653
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    611
    552
    585
    653
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    34.21 ± 10.11
    34.33 ± 10.14
    34.16 ± 10.03
    33.94 ± 10.09
    Gender categorical
    Units: Subjects
        Female
    611
    552
    585
    653
        Male
    0
    0
    0
    0

    End points

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

    Reporting group title
    Miconazole+Placebo
    Reporting group description
    		 -

    Subject analysis set title
    FAS population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS population is defined as all randomised patients excluding (as allowed by ICH E9): • Patients who did not take at least one dose of the study medication • Patients who present an STI (trichomoniasis; gonococcal and chlamydial infections) detected from the vaginal sample taken before randomisation at the Baseline Visit (Visit 1 / D1). • Patients without post-randomisation data.

    Subject analysis set title
    PPS population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPS population consists of all patients of the FAS without any major protocol deviation. This is the set of patients who participated in the study as intended. Before locking the data base, the precise reasons for excluding patients from the PP data set were fully defined and documented during a blind review meeting.

    Subject analysis set title
    mPPS Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The mPPS population consists of all patients of the FAS without any major protocol deviation except deviations about randomization process. This population was used for an additional sensitivity analysis on the PPS to document the influence of including or excluding these patients with deviations from the randomisation schedule.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SS population comprises all enrolled patients in the study, who have been administered at least one capsule of study drug.

    Primary: Clinical treatment efficacy assessed by the investigator

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    End point title
    		 Clinical treatment efficacy assessed by the investigator [1]
    End point description
    End point type
    Primary
    End point timeframe
    Visit 2 / Day 15
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The procedure for the primary endpoint statistical analysis at the final analysis is: the proportion of patients with a success according to investigator clinical assessment was computed and compared between treatment groups using a test for the difference between two binomial proportions in SAS SEQTEST procedure.
    End point values
    		 Polygynax Miconazole+Placebo FAS population
    Number of subjects analysed
    302
    309
    611
    Units: % Success
        number (not applicable)
    91.1
    86.7
    88.9
    No statistical analyses for this end point

    Secondary: Change in vaginal discharge and in each associated clinical symptoms reported by the patient in the diary

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    End point title
    		 Change in vaginal discharge and in each associated clinical symptoms reported by the patient in the diary
    End point description
    End point type
    Secondary
    End point timeframe
    From visit 1 / D1 to visit 2 / D14
    End point values
    		 Polygynax Miconazole+Placebo
    Number of subjects analysed
    302
    309
    Units: mm
    least squares mean (confidence interval 95%)
        Vaginal Discharge
    31.43 (29.94 to 32.91)
    29.54 (28.07 to 31.01)
        Vaginal Burning
    27.89 (26.66 to 29.12)
    27.03 (25.81 to 28.25)
        Vaginal Pain
    16.93 (15.86 to 18.01)
    17.17 (16.1 to 18.24)
        Vaginal Irritation
    29.37 (28.06 to 30.67)
    28.79 (27.51 to 30.08)
        Combined clinical symptoms
    28.96 (26.79 to 31.14)
    28.2 (26.04 to 30.35)
    No statistical analyses for this end point

    Secondary: Clinical treatment efficacy at end of study

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    End point title
    		 Clinical treatment efficacy at end of study
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 3 / Day 22
    End point values
    		 Polygynax Miconazole+Placebo FAS population
    Number of subjects analysed
    302
    309
    611
    Units: % Success
        number (not applicable)
    84.8
    82.5
    83.7
    No statistical analyses for this end point

    Secondary: Investigator's global satisfaction

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    End point title
    		 Investigator's global satisfaction
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 2 / Day 15
    End point values
    		 Polygynax Miconazole+Placebo FAS population
    Number of subjects analysed
    302
    309
    611
    Units: % satisfaction
    number (not applicable)
        Very Good - Good
    88.3
    82.1
    85.2
        Somewhat Good - Somewhat Bad
    8.3
    13
    10.7
        Bad - Very Bad
    3.3
    4.9
    4.1
    No statistical analyses for this end point

    Secondary: Patient's global satisfaction

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    End point title
    		 Patient's global satisfaction
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 2 / Day 15
    End point values
    		 Polygynax Miconazole+Placebo FAS population
    Number of subjects analysed
    302
    309
    611
    Units: % Satisfaction
    number (not applicable)
        Very Good - Good
    81.8
    78.2
    80
        Somewhat Good - Somewhat Bad
    17.1
    21.1
    19.2
        Bad - Very Bad
    1
    0.7
    0.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    22 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Polygynax
    Reporting group description
    		 -

    Reporting group title
    Miconazole + Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Polygynax Miconazole + Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 325 (0.31%)
    0 / 328 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Patient pregnant exposed to study medication
         subjects affected / exposed
    1 / 325 (0.31%)
    0 / 328 (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: 2%
    Non-serious adverse events
    		 Polygynax Miconazole + Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 325 (5.54%)
    5 / 328 (1.52%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 325 (5.54%)
    5 / 328 (1.52%)
         occurrences all number
    24
    6

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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