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    Clinical Trial Results:
    Effects of single dose tadalafil on urethral and anal closure function and on urinary flow in healthy females: A randomised, controlled, double-blinded, two-period cross-over study

    Summary
    EudraCT number
    		 2020-005839-76
    Trial protocol
    		 DK  
    Global end of trial date
    10 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jul 2022
    First version publication date
    27 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PDE5I-UPR-AAR-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05095077
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University hospital Bispebjerg and Fred
    Sponsor organisation address
    Bispebjerg Bakke 23, indgang 20C, 2., Copenhagen, Denmark, 2400
    Public contact
    Information, Zelo phase 1 unit, +45 60770308, thea.christoffersen@regionh.dk
    Scientific contact
    Information, Zelo phase 1 unit, +45 60770308, thea.christoffersen@regionh.dk
    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
    01 Apr 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jan 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study investigated the effect of tadalafil, a phosphodiesterase-type 5 (PDE-5) inhibitor, on urethral pressure, anal pressure and on urinary flow in healthy females.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. Written informed consent was obtained before any study related procedures. We performed minimally invasive measurements and used sterile technique where applicable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Aug 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy females were recruited by advertisement at the online research platform www.forsoegsperson.dk and via database with previous participants in similar trials.

    Pre-assignment
    Screening details
    		 Check of the in- and exclusion criteria, physical examination, vital signs

    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, Data analyst, Assessor
    Blinding implementation details
    Tadalafil and placebo were over-encapsultated in identical gelatine capsules

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Tadalafil
    Arm description
    		 Single oral dose of 40 mg tadalafil
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tadalafil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft + tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg once

    Arm title
    		 Placebo
    Arm description
    		 Single oral dose placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft + tablet
    Routes of administration
    Oral use
    Dosage and administration details
    major ingredients: Lactose monohydrate, Potato starch, Gelatine, Magnesium stearate, Talc, Gelatine capsule DB

    Number of subjects in period 1
    		Tadalafil Placebo
    Started
    24
    24
    Completed
    24
    24

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 24 24
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 24.5 (20 to 43) -
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Tadalafil
    Reporting group description
    		 Single oral dose of 40 mg tadalafil

    Reporting group title
    Placebo
    Reporting group description
    		 Single oral dose placebo

    Primary: Difference in mean resting opening urethral pressure (tadalafil vs placebo)

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    End point title
    		 Difference in mean resting opening urethral pressure (tadalafil vs placebo)
    End point description
    End point type
    Primary
    End point timeframe
    Assessment 2 hours after administration of study medication on both placebo day and tadalafil day
    End point values
    		 Tadalafil Placebo
    Number of subjects analysed
    24
    24
    Units: cmH2O
        number (confidence interval 95%)
    -6.8 (-11.8 to -1.9)
    0 (0 to 0)
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Tadalafil v Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.8
         upper limit
    		 -1.9
    Notes
    [1] - Crossover analysis

    Secondary: Difference in mean squeezing opening urethral pressure (tadalafil vs placebo)

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    End point title
    		 Difference in mean squeezing opening urethral pressure (tadalafil vs placebo)
    End point description
    End point type
    Secondary
    End point timeframe
    Assessment 2 hours after administration of study medication on both placebo day and tadalafil day
    End point values
    		 Tadalafil Placebo
    Number of subjects analysed
    24
    24
    Units: cmH20
        number (confidence interval 95%)
    -8.8 (-14.6 to -3.1)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Difference in mean resting anal opening pressure (tadalafil vs placebo)

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    End point title
    		 Difference in mean resting anal opening pressure (tadalafil vs placebo)
    End point description
    End point type
    Secondary
    End point timeframe
    Assessment 2 hours after administration of study medication on both placebo day and tadalafil day
    End point values
    		 Tadalafil Placebo
    Number of subjects analysed
    24
    24
    Units: cmH20
        number (confidence interval 95%)
    -12.9 (-20.7 to -5.0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Difference in mean squeezing anal opening pressure (tadalafil vs placebo)

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    End point title
    		 Difference in mean squeezing anal opening pressure (tadalafil vs placebo)
    End point description
    End point type
    Secondary
    End point timeframe
    Assessment 2 hours after administration of study medication on both placebo day and tadalafil day
    End point values
    		 Tadalafil Placebo
    Number of subjects analysed
    24
    24
    Units: cmH20
        number (confidence interval 95%)
    -5.7 (-17.3 to 6.0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Difference in average uroflow (Qave) (tadalafil vs placebo)

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    End point title
    		 Difference in average uroflow (Qave) (tadalafil vs placebo)
    End point description
    End point type
    Secondary
    End point timeframe
    Assessment 2.5 hours after administration of study medication on both placebo day and tadalafil day
    End point values
    		 Tadalafil Placebo
    Number of subjects analysed
    24
    24
    Units: ml/s
        number (confidence interval 95%)
    -0.8 (-2.0 to 0.4)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Difference in maximum uroflow (Qmax) (tadalafil vs placebo)

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    End point title
    		 Difference in maximum uroflow (Qmax) (tadalafil vs placebo)
    End point description
    End point type
    Secondary
    End point timeframe
    Assessment 2.5 hours after administration of study medication on both placebo day and tadalafil day
    End point values
    		 Tadalafil Placebo
    Number of subjects analysed
    24
    24
    Units: ml/s
        number (confidence interval 95%)
    -1.7 (-4.8 to 1.5)
    0 (0 to 0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From dosing on Study Day 1 to six days after Study Day 2
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Tadalafil
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Tadalafil Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tadalafil Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 24 (75.00%)
    4 / 24 (16.67%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    8 / 24 (33.33%)
    0 / 24 (0.00%)
         occurrences all number
    8
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 24 (62.50%)
    3 / 24 (12.50%)
         occurrences all number
    18
    18
    Fatigue
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 24 (4.17%)
         occurrences all number
    3
    3
    Ear and labyrinth disorders
    Nasal congestion
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 24 (0.00%)
         occurrences all number
    2
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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