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    Clinical Trial Results:
    An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation

    Summary
    EudraCT number
    2013-001650-94
    Trial protocol
    GB  
    Global end of trial date
    15 Aug 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Aug 2018
    First version publication date
    25 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    191622-133
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01917006
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Allergan
    Sponsor organisation address
    2525 Dupont Dr, Irvine, United States, 92612
    Public contact
    Clinical Trials Registry Team, Allergan, 001 877‐277‐8566, IR-CTRegistration@Allergan.com
    Scientific contact
    Therapeutic Area Head, Allergan, 001 714-246-4500, IR-CTRegistration@Allergan.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Aug 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Aug 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary study objectives were to explore the safety and efficacy of a range of doses of OnabotulinumtoxinA for the treatment of premature ejaculation in male participants.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Aug 2013
    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
    United Kingdom: 17
    Country: Number of subjects enrolled
    United States: 42
    Worldwide total number of subjects
    59
    EEA total number of subjects
    17
    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)
    59
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants received a single treatment of either placebo or OnabotulinumtoxinA (Doses 1, 2, 3, 4, 5. 6), delivered bilaterally to the bulbospongiosus muscle in randomized-treatment period. Participants who completed 12 weeks of randomized period were eligible to receive second injection with OnabotulinumtoxinA Dose 2 in Open-label Period.

    Pre-assignment period milestones
    Number of subjects started
    59
    Number of subjects completed
    57

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Not Included in mITT Population: 2
    Period 1
    Period 1 title
    Randomized-treatment Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    OnabotulinumtoxinA Dose 1
    Arm description
    OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    BOTOX®
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single treatment of OnabotulinumtoxinA Dose 1 delivered bilaterally to the bulbospongiosus muscle (BSM).

    Arm title
    OnabotulinumtoxinA Dose 2
    Arm description
    OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    BOTOX®
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single treatment of OnabotulinumtoxinA Dose 2 delivered bilaterally to the BSM.

    Arm title
    OnabotulinumtoxinA Dose 3
    Arm description
    OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    BOTOX®
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single treatment of OnabotulinumtoxinA Dose 3 delivered bilaterally to the BSM.

    Arm title
    OnabotulinumtoxinA Dose 4
    Arm description
    OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    BOTOX®
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single treatment of OnabotulinumtoxinA Dose 4 U delivered bilaterally to the BSM.

    Arm title
    OnabotulinumtoxinA Dose 5
    Arm description
    OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    BOTOX®
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single treatment of OnabotulinumtoxinA Dose 5 delivered bilaterally to the BSM.

    Arm title
    OnabotulinumtoxinA Dose 6
    Arm description
    OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    BOTOX®
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single treatment of OnabotulinumtoxinA Dose 6 delivered bilaterally to the BSM.

    Arm title
    Placebo
    Arm description
    Placebo (normal saline) injected into specified muscle per protocol on Day 1.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single treatment of Placebo delivered bilaterally to the BSM.

    Number of subjects in period 1 [1]
    OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo
    Started
    5
    7
    8
    7
    8
    7
    15
    Completed
    3
    7
    8
    7
    8
    7
    14
    Not completed
    2
    0
    0
    0
    0
    0
    1
         Lost to follow-up
    1
    -
    -
    -
    -
    -
    -
         Other Miscellaneous Reasons
    -
    -
    -
    -
    -
    -
    1
         Protocol deviation
    1
    -
    -
    -
    -
    -
    -
    Notes
    [1] - 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: Baseline characteristics are based on the mITT population and excludes 2 participants.
    Period 2
    Period 2 title
    Open-label Period
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Open-label Period: OnabotulinumtoxinA Dose 2
    Arm description
    Participants who completed 12 weeks of randomized period were eligible to receive a second injection with active drug in the Open-label Period.
    Arm type
    Experimental

    Investigational medicinal product name
    BOTOX®
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single treatment of OnabotulinumtoxinA Dose 2 delivered bilaterally to the BSM.

    Number of subjects in period 2 [2]
    Open-label Period: OnabotulinumtoxinA Dose 2
    Started
    8
    Completed
    6
    Not completed
    2
         Adverse Events
    1
         Lost to follow-up
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only 8 participants were enrolled in the Open-Label Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OnabotulinumtoxinA Dose 1
    Reporting group description
    OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 2
    Reporting group description
    OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.

    Reporting group title
    OnabotulinumtoxinA Dose 3
    Reporting group description
    OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 4
    Reporting group description
    OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 5
    Reporting group description
    OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 6
    Reporting group description
    OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    Placebo (normal saline) injected into specified muscle per protocol on Day 1.

    Reporting group values
    OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo Total
    Number of subjects
    5 7 8 7 8 7 15 57
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    5 7 8 7 8 7 15 57
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    41.2 ( 10.83 ) 41.9 ( 11.65 ) 39.1 ( 5.62 ) 39.3 ( 9.05 ) 40.1 ( 6.53 ) 39.9 ( 5.96 ) 41.0 ( 6.08 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    0 0 0 0 0 0 0 0
        Male
    5 7 8 7 8 7 15 57
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    3 4 5 5 5 6 9 37
        Black
    1 2 1 1 1 0 3 9
        Asian
    0 1 0 1 1 0 1 4
        Hispanic
    1 0 0 0 1 1 2 5
        Other
    0 0 2 0 0 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    OnabotulinumtoxinA Dose 1
    Reporting group description
    OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 2
    Reporting group description
    OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.

    Reporting group title
    OnabotulinumtoxinA Dose 3
    Reporting group description
    OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 4
    Reporting group description
    OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 5
    Reporting group description
    OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 6
    Reporting group description
    OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    Placebo (normal saline) injected into specified muscle per protocol on Day 1.
    Reporting group title
    Open-label Period: OnabotulinumtoxinA Dose 2
    Reporting group description
    Participants who completed 12 weeks of randomized period were eligible to receive a second injection with active drug in the Open-label Period.

    Primary: Change from Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)

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    End point title
    Change from Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
    End point description
    IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the sexual intercourse diary (SID). The Logarithm Value of the Geometric Mean of each individual participant’s IELT recorded in the SID up to each time point was calculated. The mean and standard deviation (SD) of log-transformed geometric mean IELTs are then calculated for each treatment group. An Analysis of Covariance (ANCOVA) Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement. The modified intent-to-treat (mITT) population included all randomized participants who received study treatment and had post-baseline intravaginal ejaculatory latency time (IELT) data available based on the dose actually received by the participant. Here, "n" is the number of participants with available data at the given time-point.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) to Week 12
    End point values
    OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo
    Number of subjects analysed
    5
    7
    8
    7
    8
    7
    15
    Units: seconds
    arithmetic mean (standard deviation)
        Baseline(n=5,6,8,7,8,7,15)
    3.57 ( 0.283 )
    3.50 ( 0.631 )
    3.46 ( 0.371 )
    3.52 ( 0.531 )
    3.53 ( 0.475 )
    3.54 ( 0.505 )
    3.46 ( 0.610 )
        Change from Baseline to Week 12(n= 5,6,8,7,8,7,15)
    0.55 ( 1.037 )
    0.69 ( 1.426 )
    0.05 ( 0.856 )
    0.30 ( 0.472 )
    0.31 ( 0.525 )
    0.59 ( 0.719 )
    0.44 ( 0.615 )
    Statistical analysis title
    OnabotulinumtoxinA Dose 1 versus (vs) Placebo
    Comparison groups
    OnabotulinumtoxinA Dose 1 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.393 [1]
    Method
    ANCOVA
    Confidence interval
    Notes
    [1] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from analysis of covariance (ANCOVA) Model with treatment as fixed effect and baseline geometric mean IELT as covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 2 vs Placebo
    Comparison groups
    OnabotulinumtoxinA Dose 2 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.263 [2]
    Method
    ANCOVA
    Confidence interval
    Notes
    [2] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 3 vs Placebo
    Comparison groups
    OnabotulinumtoxinA Dose 3 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.861 [3]
    Method
    ANCOVA
    Confidence interval
    Notes
    [3] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 4 vs Placebo
    Comparison groups
    OnabotulinumtoxinA Dose 4 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.647 [4]
    Method
    ANCOVA
    Confidence interval
    Notes
    [4] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 5 vs Placebo
    Comparison groups
    OnabotulinumtoxinA Dose 5 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.645 [5]
    Method
    ANCOVA
    Confidence interval
    Notes
    [5] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 6 vs Placebo
    Comparison groups
    OnabotulinumtoxinA Dose 6 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.343 [6]
    Method
    ANCOVA
    Confidence interval
    Notes
    [6] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.

    Secondary: Change from Baseline in Average IELT

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    End point title
    Change from Baseline in Average IELT
    End point description
    IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The average of each individual participant’s IELT recorded in the SID up to each time point was calculated. The mean and SD of average IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline average mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement. The mITT population included all randomized participants who received study treatment and had post-baseline IELT data available based on the dose actually received by the participants. Here "n" is the number of participants with available data at the given time-point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12
    End point values
    OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo
    Number of subjects analysed
    5
    7
    8
    7
    8
    7
    15
    Units: seconds
    arithmetic mean (standard deviation)
        Baseline(n=5,6,8,7,8,7,15)
    37.25 ( 10.518 )
    39.42 ( 21.504 )
    34.41 ( 10.194 )
    38.00 ( 16.008 )
    40.88 ( 16.435 )
    38.75 ( 15.596 )
    37.92 ( 16.656 )
        Change from Baseline to Week 2(n=5,6,8,7,8,7,14)
    66.25 ( 101.132 )
    180.31 ( 317.657 )
    24.73 ( 59.725 )
    34.87 ( 74.842 )
    28.04 ( 31.298 )
    55.77 ( 65.549 )
    11.25 ( 23.985 )
        Change from Baseline to Week 4(n=5,6,8,7,8,7,14)
    61.94 ( 100.446 )
    176.71 ( 367.665 )
    24.06 ( 59.472 )
    35.00 ( 73.475 )
    28.46 ( 36.881 )
    64.97 ( 67.471 )
    29.30 ( 69.073 )
        Change from Baseline to Week 6(n=5,6,8,7,8,7,14)
    61.42 ( 100.446 )
    183.44 ( 374.404 )
    20.75 ( 55.850 )
    36.95 ( 71.996 )
    29.35 ( 39.334 )
    64.49 ( 66.546 )
    47.62 ( 89.847 )
        Change from Baseline to Week 8(n=5,6,8,7,8,7,14)
    59.55 ( 100.896 )
    176.59 ( 349.777 )
    17.08 ( 44.158 )
    37.69 ( 71.873 )
    29.48 ( 44.505 )
    65.19 ( 65.612 )
    65.57 ( 128.470 )
        Change from Baseline to Week 10(n=5,6,8,7,8,7,15)
    56.13 ( 101.447 )
    170.65 ( 331.039 )
    15.55 ( 39.149 )
    37.45 ( 71.782 )
    27.49 ( 45.365 )
    63.91 ( 67.725 )
    68.26 ( 146.330 )
        Change from Baseline to Week 12(n=5,6,8,7,8,7,15)
    53.65 ( 102.527 )
    152.74 ( 295.219 )
    12.95 ( 30.930 )
    28.32 ( 48.965 )
    27.51 ( 48.720 )
    66.01 ( 71.489 )
    68.49 ( 151.680 )
    Statistical analysis title
    OnabotulinumtoxinA Dose 1 vs Placebo at Week 2
    Comparison groups
    OnabotulinumtoxinA Dose 1 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.184 [7]
    Method
    ANCOVA
    Confidence interval
    Notes
    [7] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 2 vs Placebo at Week 2
    Comparison groups
    OnabotulinumtoxinA Dose 2 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002 [8]
    Method
    ANCOVA
    Confidence interval
    Notes
    [8] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 3 vs Placebo at Week 2
    Comparison groups
    OnabotulinumtoxinA Dose 3 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.404 [9]
    Method
    ANCOVA
    Confidence interval
    Notes
    [9] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 4 vs Placebo at Week 2
    Comparison groups
    OnabotulinumtoxinA Dose 4 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.328 [10]
    Method
    ANCOVA
    Confidence interval
    Notes
    [10] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 5 vs Placebo at Week 2
    Comparison groups
    OnabotulinumtoxinA Dose 5 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.362 [11]
    Method
    ANCOVA
    Confidence interval
    Notes
    [11] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 6 vs Placebo at Week 2
    Comparison groups
    OnabotulinumtoxinA Dose 6 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.203 [12]
    Method
    ANCOVA
    Confidence interval
    Notes
    [12] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 1 vs Placebo at Week 4
    Comparison groups
    OnabotulinumtoxinA Dose 1 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.322 [13]
    Method
    ANCOVA
    Confidence interval
    Notes
    [13] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 2 vs Placebo at Week 4
    Comparison groups
    OnabotulinumtoxinA Dose 2 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.015 [14]
    Method
    ANCOVA
    Confidence interval
    Notes
    [14] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 3 vs Placebo at Week 4
    Comparison groups
    OnabotulinumtoxinA Dose 3 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.541 [15]
    Method
    ANCOVA
    Confidence interval
    Notes
    [15] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 4 vs Placebo at Week 4
    Comparison groups
    OnabotulinumtoxinA Dose 4 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.459 [16]
    Method
    ANCOVA
    Confidence interval
    Notes
    [16] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 5 vs Placebo at Week 4
    Comparison groups
    OnabotulinumtoxinA Dose 5 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.491 [17]
    Method
    ANCOVA
    Confidence interval
    Notes
    [17] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 6 vs Placebo at Week 4
    Comparison groups
    OnabotulinumtoxinA Dose 6 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.281 [18]
    Method
    ANCOVA
    Confidence interval
    Notes
    [18] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 1 vs Placebo at Week 6
    Comparison groups
    OnabotulinumtoxinA Dose 1 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.424 [19]
    Method
    ANCOVA
    Confidence interval
    Notes
    [19] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 2 vs Placebo at Week 6
    Comparison groups
    OnabotulinumtoxinA Dose 2 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.026 [20]
    Method
    ANCOVA
    Confidence interval
    Notes
    [20] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 3 vs Placebo at Week 6
    Comparison groups
    OnabotulinumtoxinA Dose 3 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.67 [21]
    Method
    ANCOVA
    Confidence interval
    Notes
    [21] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 4 vs Placebo at Week 6
    Comparison groups
    OnabotulinumtoxinA Dose 4 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.561 [22]
    Method
    ANCOVA
    Confidence interval
    Notes
    [22] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 5 vs Placebo at Week 6
    Comparison groups
    OnabotulinumtoxinA Dose 5 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.604 [23]
    Method
    ANCOVA
    Confidence interval
    Notes
    [23] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 6 vs Placebo at Week 6
    Comparison groups
    OnabotulinumtoxinA Dose 6 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.394 [24]
    Method
    ANCOVA
    Confidence interval
    Notes
    [24] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 1 vs Placebo at Week 8
    Comparison groups
    OnabotulinumtoxinA Dose 1 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.532 [25]
    Method
    ANCOVA
    Confidence interval
    Notes
    [25] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 2 vs Placebo at Week 8
    Comparison groups
    OnabotulinumtoxinA Dose 2 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.058 [26]
    Method
    ANCOVA
    Confidence interval
    Notes
    [26] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 3 vs Placebo at Week 8
    Comparison groups
    OnabotulinumtoxinA Dose 3 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.778 [27]
    Method
    ANCOVA
    Confidence interval
    Notes
    [27] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 4 vs Placebo at Week 8
    Comparison groups
    OnabotulinumtoxinA Dose 4 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.662 [28]
    Method
    ANCOVA
    Confidence interval
    Notes
    [28] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 5 vs Placebo at Week 8
    Comparison groups
    OnabotulinumtoxinA Dose 5 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.712 [29]
    Method
    ANCOVA
    Confidence interval
    Notes
    [29] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 6 vs Placebo at Week 8
    Comparison groups
    OnabotulinumtoxinA Dose 6 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.501 [30]
    Method
    ANCOVA
    Confidence interval
    Notes
    [30] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 1 vs Placebo at Week 10
    Comparison groups
    OnabotulinumtoxinA Dose 1 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.565 [31]
    Method
    ANCOVA
    Confidence interval
    Notes
    [31] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 2 vs Placebo at Week 10
    Comparison groups
    OnabotulinumtoxinA Dose 2 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.071 [32]
    Method
    ANCOVA
    Confidence interval
    Notes
    [32] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 3 vs Placebo at Week 10
    Comparison groups
    OnabotulinumtoxinA Dose 3 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.799 [33]
    Method
    ANCOVA
    Confidence interval
    Notes
    [33] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 4 vs Placebo at Week 10
    Comparison groups
    OnabotulinumtoxinA Dose 4 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.681 [34]
    Method
    ANCOVA
    Confidence interval
    Notes
    [34] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 5 vs Placebo at Week 10
    Comparison groups
    OnabotulinumtoxinA Dose 5 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.741 [35]
    Method
    ANCOVA
    Confidence interval
    Notes
    [35] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 6 vs Placebo at Week 10
    Comparison groups
    OnabotulinumtoxinA Dose 6 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.526 [36]
    Method
    ANCOVA
    Confidence interval
    Notes
    [36] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 1 vs Placebo at Week 12
    Comparison groups
    OnabotulinumtoxinA Dose 1 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.584 [37]
    Method
    ANCOVA
    Confidence interval
    Notes
    [37] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 2 vs Placebo at Week 12
    Comparison groups
    OnabotulinumtoxinA Dose 2 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.101 [38]
    Method
    ANCOVA
    Confidence interval
    Notes
    [38] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 3 vs Placebo at Week 12
    Comparison groups
    OnabotulinumtoxinA Dose 3 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.823 [39]
    Method
    ANCOVA
    Confidence interval
    Notes
    [39] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 4 vs Placebo at Week 12
    Comparison groups
    OnabotulinumtoxinA Dose 4 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.741 [40]
    Method
    ANCOVA
    Confidence interval
    Notes
    [40] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 5 vs Placebo at Week 12
    Comparison groups
    OnabotulinumtoxinA Dose 5 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.756 [41]
    Method
    ANCOVA
    Confidence interval
    Notes
    [41] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 6 vs Placebo at Week 12
    Comparison groups
    OnabotulinumtoxinA Dose 6 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.517 [42]
    Method
    ANCOVA
    Confidence interval
    Notes
    [42] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.

    Secondary: Change from Baseline in Geometric Mean IELT

    Close Top of page
    End point title
    Change from Baseline in Geometric Mean IELT
    End point description
    IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The Logarithm Value of the Geometric Mean of each individual participant’s IELT recorded in the SID up to each time point was calculated. The mean and SD of log-transformed geometric mean IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement. The mITT population included all randomized participants who received study treatment and had post-baseline IELT data available based on the dose actually received by the participant. Here "n" is the number of participants with available data at the given time-point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10
    End point values
    OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo
    Number of subjects analysed
    5
    7
    8
    7
    8
    7
    15
    Units: seconds
    arithmetic mean (standard deviation)
        Baseline(n=5,6,8,7,8,7,15)
    3.57 ( 0.283 )
    3.50 ( 0.631 )
    3.46 ( 0.371 )
    3.52 ( 0.531 )
    3.53 ( 0.475 )
    3.54 ( 0.505 )
    3.46 ( 0.610 )
        Change at Week 2(n=5,6,8,7,8,7,14)
    0.76 ( 1.014 )
    0.95 ( 1.497 )
    0.26 ( 0.677 )
    0.34 ( 0.690 )
    0.47 ( 0.604 )
    0.62 ( 0.623 )
    0.19 ( 0.486 )
        Change at Week 4(n=5,6,8,7,8,7,14)
    0.70 ( 1.000 )
    0.77 ( 1.505 )
    0.18 ( 0.879 )
    0.33 ( 0.616 )
    0.38 ( 0.481 )
    0.61 ( 0.618 )
    0.22 ( 0.627 )
        Change at Week 6(n=5,6,8,7,8,7,14)
    0.70 ( 0.999 )
    0.83 ( 1.513 )
    0.08 ( 0.971 )
    0.36 ( 0.629 )
    0.36 ( 0.483 )
    0.59 ( 0.722 )
    0.36 ( 0.524 )
        Change at Week 8(n=5,6,8,7,8,7,14)
    0.67 ( 1.007 )
    0.79 ( 1.525 )
    0.05 ( 0.968 )
    0.37 ( 0.627 )
    0.36 ( 0.522 )
    0.61 ( 0.682 )
    0.44 ( 0.567 )
        Change at Week 10(n=5,6,8,7,8,7,15)
    0.60 ( 1.009 )
    0.80 ( 1.503 )
    0.07 ( 0.905 )
    0.37 ( 0.624 )
    0.32 ( 0.512 )
    0.56 ( 0.727 )
    0.44 ( 0.603 )
    Statistical analysis title
    OnabotulinumtoxinA Dose 1 vs Placebo at Week 2
    Comparison groups
    OnabotulinumtoxinA Dose 1 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.079 [43]
    Method
    ANCOVA
    Confidence interval
    Notes
    [43] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 2 vs Placebo at Week 2
    Comparison groups
    OnabotulinumtoxinA Dose 2 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.025 [44]
    Method
    ANCOVA
    Confidence interval
    Notes
    [44] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 3 vs Placebo at Week 2
    Comparison groups
    OnabotulinumtoxinA Dose 3 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.417 [45]
    Method
    ANCOVA
    Confidence interval
    Notes
    [45] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 4 vs Placebo at Week 2
    Comparison groups
    OnabotulinumtoxinA Dose 4 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.33 [46]
    Method
    ANCOVA
    Confidence interval
    Notes
    [46] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 5 vs Placebo at Week 2
    Comparison groups
    OnabotulinumtoxinA Dose 5 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.199 [47]
    Method
    ANCOVA
    Confidence interval
    Notes
    [47] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 6 vs Placebo at Week 2
    Comparison groups
    OnabotulinumtoxinA Dose 6 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.113 [48]
    Method
    ANCOVA
    Confidence interval
    Notes
    [48] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 1 vs Placebo at Week 4
    Comparison groups
    OnabotulinumtoxinA Dose 1 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.127 [49]
    Method
    ANCOVA
    Confidence interval
    Notes
    [49] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 2 vs Placebo at Week 4
    Comparison groups
    OnabotulinumtoxinA Dose 2 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.087 [50]
    Method
    ANCOVA
    Confidence interval
    Notes
    [50] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 3 vs Placebo at Week 4
    Comparison groups
    OnabotulinumtoxinA Dose 3 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.543 [51]
    Method
    ANCOVA
    Confidence interval
    Notes
    [51] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 4 vs Placebo at Week 4
    Comparison groups
    OnabotulinumtoxinA Dose 4 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.377 [52]
    Method
    ANCOVA
    Confidence interval
    Notes
    [52] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 5 vs Placebo at Week 4
    Comparison groups
    OnabotulinumtoxinA Dose 5 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.321 [53]
    Method
    ANCOVA
    Confidence interval
    Notes
    [53] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 6 vs Placebo at Week 4
    Comparison groups
    OnabotulinumtoxinA Dose 6 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.149 [54]
    Method
    ANCOVA
    Confidence interval
    Notes
    [54] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 1 vs Placebo at Week 6
    Comparison groups
    OnabotulinumtoxinA Dose 1 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.215 [55]
    Method
    ANCOVA
    Confidence interval
    Notes
    [55] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 2 vs Placebo at Week 6
    Comparison groups
    OnabotulinumtoxinA Dose 2 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.126 [56]
    Method
    ANCOVA
    Confidence interval
    Notes
    [56] - A one-sided p-value of mean difference vs placebo for each active BOTOX dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 3 vs Placebo at Week 6
    Comparison groups
    OnabotulinumtoxinA Dose 3 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.774 [57]
    Method
    ANCOVA
    Confidence interval
    Notes
    [57] - A one-sided p-value of mean difference vs placebo for each active BOTOX dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 4 vs Placebo at Week 6
    Comparison groups
    OnabotulinumtoxinA Dose 4 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.495 [58]
    Method
    ANCOVA
    Confidence interval
    Notes
    [58] - A one-sided p-value of mean difference vs placebo for each active BOTOX dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 5 vs Placebo at Week 6
    Comparison groups
    OnabotulinumtoxinA Dose 5 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.495 [59]
    Method
    ANCOVA
    Confidence interval
    Notes
    [59] - A one-sided p-value of mean difference vs placebo for each active BOTOX dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 6 vs Placebo at Week 6
    Comparison groups
    OnabotulinumtoxinA Dose 6 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.274 [60]
    Method
    ANCOVA
    Confidence interval
    Notes
    [60] - A one-sided p-value of mean difference vs placebo for each active BOTOX dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 1 vs Placebo at Week 8
    Comparison groups
    OnabotulinumtoxinA Dose 1 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.308 [61]
    Method
    ANCOVA
    Confidence interval
    Notes
    [61] - A one-sided p-value of mean difference vs placebo for each active BOTOX dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 2 vs Placebo at Week 8
    Comparison groups
    OnabotulinumtoxinA Dose 2 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.205 [62]
    Method
    ANCOVA
    Confidence interval
    Notes
    [62] - A one-sided p-value of mean difference vs placebo for each active BOTOX dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 3 vs Placebo at Week 8
    Comparison groups
    OnabotulinumtoxinA Dose 3 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.849 [63]
    Method
    ANCOVA
    Confidence interval
    Notes
    [63] - A one-sided p-value of mean difference vs placebo for each active BOTOX dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 4 vs Placebo at Week 8
    Comparison groups
    OnabotulinumtoxinA Dose 4 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.571 [64]
    Method
    ANCOVA
    Confidence interval
    Notes
    [64] - A one-sided p-value of mean difference vs placebo for each active BOTOX dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 5 vs Placebo at Week 8
    Comparison groups
    OnabotulinumtoxinA Dose 5 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.592 [65]
    Method
    ANCOVA
    Confidence interval
    Notes
    [65] - A one-sided p-value of mean difference vs placebo for each active BOTOX dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 6 vs Placebo at Week 8
    Comparison groups
    OnabotulinumtoxinA Dose 6 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.34 [66]
    Method
    ANCOVA
    Confidence interval
    Notes
    [66] - A one-sided p-value of mean difference vs placebo for each active BOTOX dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 1 vs Placebo at Week 10
    Comparison groups
    OnabotulinumtoxinA Dose 1 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [67]
    Method
    ANCOVA
    Confidence interval
    Notes
    [67] - A one-sided p-value of mean difference vs placebo for each active BOTOX dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 2 vs Placebo at Week 10
    Comparison groups
    OnabotulinumtoxinA Dose 2 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.192 [68]
    Method
    ANCOVA
    Confidence interval
    Notes
    [68] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 3 vs Placebo at Week 10
    Comparison groups
    OnabotulinumtoxinA Dose 3 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.843 [69]
    Method
    ANCOVA
    Confidence interval
    Notes
    [69] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 4 vs Placebo at Week 10
    Comparison groups
    OnabotulinumtoxinA Dose 4 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.572 [70]
    Method
    ANCOVA
    Confidence interval
    Notes
    [70] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 5 vs Placebo at Week 10
    Comparison groups
    OnabotulinumtoxinA Dose 5 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.628 [71]
    Method
    ANCOVA
    Confidence interval
    Notes
    [71] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
    Statistical analysis title
    OnabotulinumtoxinA Dose 6 vs Placebo at Week 10
    Comparison groups
    OnabotulinumtoxinA Dose 6 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.38 [72]
    Method
    ANCOVA
    Confidence interval
    Notes
    [72] - A one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
    Adverse event reporting additional description
    A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    OnabotulinumtoxinA Dose 1
    Reporting group description
    OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 2
    Reporting group description
    OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 3
    Reporting group description
    OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 4
    Reporting group description
    OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 6
    Reporting group description
    OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 5
    Reporting group description
    OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    Placebo (normal saline) injected into specified muscle per protocol on Day 1.

    Reporting group title
    OnabotulinumtoxinA Dose 2 (Open-label Period)
    Reporting group description
    Participants who completed 12 weeks of randomized period were eligible to receive a second injection with active drug in the Open-label Period.

    Serious adverse events
    OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 6 OnabotulinumtoxinA Dose 5 Placebo OnabotulinumtoxinA Dose 2 (Open-label Period)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 6 OnabotulinumtoxinA Dose 5 Placebo OnabotulinumtoxinA Dose 2 (Open-label Period)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    2 / 7 (28.57%)
    1 / 8 (12.50%)
    2 / 8 (25.00%)
    4 / 8 (50.00%)
    3 / 8 (37.50%)
    12 / 15 (80.00%)
    3 / 8 (37.50%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    1 / 8 (12.50%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    Chills
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Injection site paraesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Reproductive system and breast disorders
    Ejaculation disorder
         subjects affected / exposed
    3 / 5 (60.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    6
    0
    0
    0
    0
    0
    3
    0
    Epididymal tenderness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Perineal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Pruritus genital
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Erectile dysfunction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Ejaculation failure
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Sinus congestion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    Enuresis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Psychogenic erectile dysfunction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Investigations
    Semen volume decreased
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    0
    Heart rate irregular
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Penis injury
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Concussion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Contusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Road traffic accident
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    3 / 15 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    4
    0
    Dizziness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Loss of consciousness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Memory impairment
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Abnormal faeces
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dyshidrotic eczema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Skin odour abnormal
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    Rosacea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Terminal dribbling
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Urine odour abnormal
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Endocrine disorders
    Hypogonadism
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    0
    Muscle spasms
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    3 / 15 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    Arthralgia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    3 / 15 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    3
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Ear infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Apr 2015
    Amendment 1 • The first amendment of the protocol was implemented prior to enrollment for Cohort 5 • This amendment incorporated collection and analysis for an additional exploratory efficacy endpoint • Using an ultrasound, various measurements of participants bulbospongiosus muscle (BSM) were taken prior to treatment and at the Week 4 visit • The statistical analysis plan (SAP) was amended to include an analysis of these measurements, which was descriptive in nature • The collection and analysis of the BSM were only undertaken with participants in Cohort 5 and subsequently excluded in Amendment 2 • Additionally, after the Data Review Committee’s (DRC’s) review of safety data from the first 6 participants in Cohort 5, it was decided to reduce the dosage for subsequent participants enrolled into the active treatment arm of Cohort 5. The active dose was reduced from OnabotulinumtoxinA Dose 1 down to OnabotulinumtoxinA Dose 2. Since authority to do so was granted to the DRC in both the original study protocol as well as DRC charter, a protocol amendment was not required • Other than inclusion of an additional treatment arm, this decision implied no material change to the planned statistical analysis. Consequently, a SAP amendment was not needed.
    15 Jul 2016
    Amendment 2 • The second amendment to the protocol occurred prior to the start of Cohort 6 • This amendment stipulated an increase in the number of participants enrolled into Cohort 6 from 10 to 24 as well as changing the dosage of the active treatment from OnabotulinumtoxinA Dose A to OnabotulinumtoxinA Dose 2 • Additionally, participants in Cohort 6 had the option to enter a 12-week open-label extension period • As mentioned earlier, the BSM measurements included in Amendment 1 were removed for Amendment 2 • The SAP was amended to incorporate analysis for the open-label period that was descriptive in nature.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Feb 2015
    The study was on an enrollment hold due to a major protocol amendment and adding the Dose 2 dose. The hold was not mandated by Food and Drug Administration (FDA), but was necessary to program our interactive web response system (IWRS) and Electronic Data Capture (EDC) systems to account for the major changes. The hold went from Sept 2015 to May of 2016.
    -

    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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    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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