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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, home use, cross-over clinical trial of topically-applied glyceryl trinitrate (GTN) for the treatment of Erectile Dysfunction

    Summary
    EudraCT number
    		 2014-005571-89
    Trial protocol
    		 GB   PL  
    Global end of trial date
    30 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Nov 2021
    First version publication date
    20 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FM53
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02495467
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 C14063: Richmond Pharmacology Ltd. Study Number
    Sponsors
    Sponsor organisation name
    Futura Medical Developments Limited
    Sponsor organisation address
    40 Occam Road, Guildford, United Kingdom, GU2 7YG
    Public contact
    Andy Graham - Senior Clinical Project Manager, Futura Medical Developments Limited, +44 01483 685670, andy.graham@futuramedical.com
    Scientific contact
    Andy Graham - Senior Clinical Project Manager, Futura Medical Developments Limited, +44 01483 685670, andy.graham@futuramedical.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
    30 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess how well a new medication known as MED2005 works (i.e.causes an erection) when applied to the penis of male volunteers self-diagnosed with Erectile Dysfunction (ED) using scores from a validated questionnaire known as IIEF (International Index for Erectile Function).
    Protection of trial subjects
    Treated in routine care. The study included careful monitoring of any potential adverse events
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 May 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 178
    Country: Number of subjects enrolled
    Poland: 54
    Worldwide total number of subjects
    232
    EEA total number of subjects
    54
    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)
    216
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 392 subjects were screened. 232 subjects fulfilled the eligibility criteria and were randomised.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 MED Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    MED2005 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Single topical application of a small pea sized amount (approx. 300 mg) prior to sexual intercourse.

    Arm title
    		 MED2005
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MED2005
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Single topical application of a small pea sized amount (approx. 300 mg) prior to sexual intercourse.

    Number of subjects in period 1
    		MED Placebo MED2005
    Started
    230
    230
    Completed
    227
    230
    Not completed
    3
    0
         Consent withdrawn by subject
    1
    -
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Overall
    Reporting group description
    		 -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 subject out of the 232 randomised was not treated and was not included in the summary.
    Reporting group values
    		 Overall Total
    Number of subjects
    		 231 231
    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)
    		 16 16
        From 65-84 years
    		 215 215
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.0 ( 14.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 231 231
    Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF)
    Units: Score
        arithmetic mean (standard deviation)
    		 ( ) -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised subjects who reported at least one intercourse attempt and had at least one efficacy assessment in a period for which at least one intercourse attempt was reported.

    Subject analysis sets values
    		 Full Analysis Set
    Number of subjects
    230
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    16
        From 65-84 years
    214
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.0 ( 14.2 )
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    230
    Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF)
    Units: Score
        arithmetic mean (standard deviation)
    17.1 ( 5.7 )

    End points

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    End points reporting groups
    Reporting group title
    MED Placebo
    Reporting group description
    		 -

    Reporting group title
    MED2005
    Reporting group description
    		 -

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised subjects who reported at least one intercourse attempt and had at least one efficacy assessment in a period for which at least one intercourse attempt was reported.

    Primary: Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire

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    End point title
    		 Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire
    End point description
    End point type
    Primary
    End point timeframe
    4 weeks
    End point values
    		 MED Placebo MED2005
    Number of subjects analysed
    225
    223
    Units: Score
        arithmetic mean (standard deviation)
    18.5 ( 6.7 )
    19.6 ( 7.5 )
    Statistical analysis title
    		 Primary Outcome
    Statistical analysis description
    The EF domain score of the IIEF was analysed using a linear mixed model with treatment, period and sequence as fixed effects, subject as random effect and baseline (run-in) as covariate.
    Comparison groups
    MED Placebo v MED2005
    Number of subjects included in analysis
    448
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0132
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 1.84

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    4 weeks on treatment plus 1 week follow-up.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    MED Placebo
    Reporting group description
    		 -

    Reporting group title
    MED2005
    Reporting group description
    		 -

    Serious adverse events
    		 MED Placebo MED2005
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 227 (0.00%)
    0 / 229 (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
    		 MED Placebo MED2005
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 227 (7.93%)
    31 / 229 (13.54%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 227 (3.08%)
    18 / 229 (7.86%)
         occurrences all number
    7
    20
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    11 / 227 (4.85%)
    13 / 229 (5.68%)
         occurrences all number
    11
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jun 2015
    The initial protocol (v1.0, 23 Feb 2015) was submitted to the EC and was updated in response to conditional approval from EC to v2.0, 10 Apr 2015, which was subsequently approved. This version of the protocol was submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) but changes were made in response to the ‘Grounds for non-acceptance notification’ that was received. The protocol was therefore updated to v3.0, 17 Jun 2015, which was approved by the MHRA. Due to the changes, this version of the protocol was then submitted to EC as a substantial amendment (No. 1).
    07 Jul 2015
    Update of the application leaflet.
    24 Jul 2015
    Inclusion of up to 4 additional sites in Poland Changes to inclusion criteria Addition of a pregnancy test for female partners Update of the frequency of GAQ questionnaire and correction of administration errors The EC provided an unfavourable opinion, so changes were made to the protocol accordingly and this was re-submitted as v5.0. This version was then approved by the EC.
    04 Aug 2015
    Extension of the shelf-life of placebo from 12 months to 18 months Addition of MedPharm as an alternative/additional site for IMP labelling and final release (to Sharp) An updated IMPD (17 Dec 2015) was submitted for review
    11 Jan 2016
    Amendment to the IMP specified description to avoid confusion during QC/Qualified Person release. Active and placebo descriptions amended from ‘Turbid high viscosity gel’ to ‘Clear to turbid gel’. An updated IMPD (11 Jan 2016) was submitted for review.

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

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29306609
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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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