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    Clinical Trial Results:
    A multicentre, randomized, double-blind, parallel-group, controlled study, to assess the efficacy and safety of P-3074 cutaneous spray, solution, in the treatment of male pattern baldness.

    Summary
    EudraCT number
    		 2015-002877-40
    Trial protocol
    		 DE   HU   BE   ES  
    Global end of trial date
    05 Mar 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    21 Jun 2019
    First version publication date
    15 Mar 2019
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    The number of deaths (all causes) needs to be corrected in full data set

    Trial information

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    Trial identification
    Sponsor protocol code
    PM1541
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03004469
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Polichem S.A.
    Sponsor organisation address
    50, Val Fleuri Luxembourg, legally represented by branch in, Lugano-Pazzallo, Switzerland, CH-6912
    Public contact
    Francesco Scarci, Polichem S.A., +41 091 9864 005, francesco.scarci@almirall.com
    Scientific contact
    Francesco Scarci, Polichem S.A., +41 091 9864 005, francesco.scarci@almirall.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
    16 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether a daily treatment with P-3074 for 24 weeks increases hair count in men with male pattern baldness (MPB) compared to the vehicle.
    Protection of trial subjects
    The study was conducted under the provisions of the Declaration of Helsinki, and in accordance with the International Conference on Harmonization (ICH) Consolidated Guideline on Good Clinical Practice (GCP).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Aug 2016
    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
    Spain: 37
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    Germany: 286
    Country: Number of subjects enrolled
    Hungary: 38
    Country: Number of subjects enrolled
    Russian Federation: 84
    Worldwide total number of subjects
    458
    EEA total number of subjects
    374
    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)
    458
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in 5 countries, in 52 sites and was initiated on 02 Aug 2016 (First subject first visit) and the study got completed on 05 Mar 2018 (Last subject last visit).

    Pre-assignment
    Screening details
    		 A total of 632 subjects were screened, with 458 subjects being randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 P-3074 + Finasteride Placebo
    Arm description
    		 Subjects received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    P-3074
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous spray, solution
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) for 24 weeks.

    Investigational medicinal product name
    Finasteride Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo of finasteride 1-milligram (mg) tablet orally once daily for 24 weeks.

    Arm title
    		 P-3074 Vehicle + Finasteride Placebo
    Arm description
    		 Subjects received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    P-3074 Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous spray, solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Subjects received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for 24 weeks.

    Investigational medicinal product name
    Finasteride Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received placebo of finasteride 1 mg tablet orally once daily for 24 weeks

    Arm title
    		 Oral Finasteride + P-3074 Vehicle
    Arm description
    		 Subjects received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Finasteride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received finasteride 1 mg tablet orally once daily for 24 weeks.

    Investigational medicinal product name
    P-3074 Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous spray, solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Subject received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for 24 weeks.

    Number of subjects in period 1
    		P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
    Started
    189
    184
    85
    Completed
    128
    135
    60
    Not completed
    61
    49
    25
         Consent withdrawn by subject
    29
    27
    10
         Non-Compliance with Study Drug
    2
    -
    -
         Adverse event, non-fatal
    6
    4
    6
         Protocol violation
    -
    -
    1
         Unspecified reason
    -
    4
    1
         Lost to follow-up
    23
    14
    6
         Lack of efficacy
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    P-3074 + Finasteride Placebo
    Reporting group description
    		 Subjects received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.

    Reporting group title
    P-3074 Vehicle + Finasteride Placebo
    Reporting group description
    		 Subjects received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.

    Reporting group title
    Oral Finasteride + P-3074 Vehicle
    Reporting group description
    		 Subjects received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.

    Reporting group values
    		 P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle Total
    Number of subjects
    		 189 184 85 458
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.7 ± 5.4 32.0 ± 4.8 31.9 ± 5.6 -
    Gender categorical
    Units: Subjects
        Male
    		 189 184 85 458
    Race
    Units: Subjects
        Asian
    		 2 1 0 3
        Black/African American
    		 0 0 1 1
        Caucasian/White
    		 187 181 83 451
        Other
    		 0 2 1 3

    End points

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    End points reporting groups
    Reporting group title
    P-3074 + Finasteride Placebo
    Reporting group description
    		 Subjects received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.

    Reporting group title
    P-3074 Vehicle + Finasteride Placebo
    Reporting group description
    		 Subjects received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.

    Reporting group title
    Oral Finasteride + P-3074 Vehicle
    Reporting group description
    		 Subjects received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.

    Primary: Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24

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    End point title
    		 Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24
    End point description
    The change from baseline in the TAHC within a 1 cm^2 (square centimeter) of baldness area at Week 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline. The data provided here is for Intent-to-Treat (ITT) Population included all subjects who had measurements both at baseline and on treatment: i.e. subjects who had measurements in regards to hair count both at baseline and on treatment. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    End point values
    		 P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
    Number of subjects analysed
    105
    97
    48
    Units: hairs
        arithmetic mean (standard deviation)
    20.2 ± 2.88
    6.7 ± 3.01
    21.1 ± 3.90
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    13.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.8
         upper limit
    		 21.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.94

    Secondary: Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12

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    End point title
    		 Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12
    End point description
    The change from baseline in the TAHC within a 1 cm^2 of baldness area at Week 12, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline. The data provided here is for ITT Population included all subjects who had measurements both at baseline and on treatment: i.e. subjects who had measurements in regards to hair count both at baseline and on treatment. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
    Number of subjects analysed
    105
    97
    48
    Units: hairs
        arithmetic mean (standard deviation)
    20.4 ± 2.41
    7.6 ± 2.46
    22.5 ± 3.31
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    12.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.5
         upper limit
    		 19.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.19

    Secondary: Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24

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    End point title
    		 Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24
    End point description
    The change from baseline in the TAHW within a 1 cm^2 of baldness area at Weeks 12 and 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Weeks 12 and 24 minus baseline, respectively. The data provided here is for ITT Population included all subjects who had measurements both at baseline and on treatment: i.e. subjects who had measurements in regards to hair count both at baseline and on treatment. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
    Number of subjects analysed
    105
    97
    48
    Units: micrometer
    arithmetic mean (standard deviation)
        Week 12
    -1.1231 ± 0.30653
    -0.7207 ± 0.31033
    -0.6938 ± 0.41951
        Week 24
    -0.8052 ± 0.35151
    -1.5289 ± 0.36691
    0.7163 ± 0.46679
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Statistical Analysis details presented here is for Week 12
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.322
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.4024
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.202
         upper limit
    		 0.3971
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4057
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Statistical Analysis details presented here is for Week 24
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.131
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.7237
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2184
         upper limit
    		 1.6657
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.47799

    Secondary: Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Subject at Weeks 12 and 24

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    End point title
    		 Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Subject at Weeks 12 and 24
    End point description
    Subjects assessed their scalp hair using a validated, self-administered MHGQ, which was given in their language. The self-administered MHGQ overall score assessed using the following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. A higher score indicated a worse outcome. The questionnaire was administered to eligible subjects to subjectively measure their perception of hair growth. A higher score indicated a worse outcome. The data provided here is for ITT Population included all subjects who had measurements both at baseline and on treatment: i.e. subjects who had measurements in regards to hair count both at baseline and on treatment. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
    Number of subjects analysed
    105
    97
    48
    Units: score on a scale
    arithmetic mean (standard error)
        Week 12
    2.9 ± 0.08
    3.0 ± 0.09
    2.8 ± 0.12
        Week 24
    2.8 ± 0.09
    3.0 ± 0.10
    2.9 ± 0.13
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Statistical Analysis details presented here is for Week 12
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.569
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Statistical Analysis details presented here is for Week 24
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.129
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12

    Secondary: Adjusted Mean Change From Baseline in Subject Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Investigator

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    End point title
    		 Adjusted Mean Change From Baseline in Subject Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Investigator
    End point description
    The local Investigator assessed change in hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale. The evaluation was done by the Investigator or designee, by comparing the global vertex view photograph obtained at baseline visit with the subjects actual scalp at 12 and 24 weeks. For the purpose of assessment of changes in hair growth by Investigators screening visits (where global photos were taken) were used as Baseline. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. The data provided here is for ITT Population. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
    Number of subjects analysed
    105
    97
    48
    Units: score on a scale
    arithmetic mean (standard error)
        Week 12
    0.5 ± 0.10
    0.4 ± 0.11
    0.5 ± 0.15
        Week 24
    0.8 ± 0.09
    0.3 ± 0.09
    0.7 ± 12
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Statistical Analysis details presented here is for Week 12
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.708
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Statistical Analysis details presented here is for Week 24
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12

    Secondary: Adjusted Mean Change From Baseline in Subject Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor

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    End point title
    		 Adjusted Mean Change From Baseline in Subject Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor
    End point description
    An independent blinded assessor was responsible for evaluating, under blinded conditions, the screening global photographs of the target area for all subjects. They evaluated the eligibility of each subjects according to the clinical inclusion criteria. The independent blinded assessor assessed the change of the hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. This assessment was performed by comparing the global photographs obtained at screening visit with those subsequently obtained at Weeks 12 and 24. The data provided here is for ITT. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 and Week 24
    End point values
    		 P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
    Number of subjects analysed
    105
    97
    48
    Units: score on a scale
    arithmetic mean (standard error)
        Week 12
    0.0 ± 0.08
    0.2 ± 0.08
    0.2 ± 0.11
        Week 24
    0.2 ± 0.09
    0.1 ± 0.09
    0.3 ± 0.12
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Statistical Analysis details presented here is for Week 12
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.179
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Statistical Analysis details presented here is for Week 24
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.262
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12

    Secondary: Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24

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    End point title
    		 Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24
    End point description
    The 15-question IIEF-2 Questionnaire (Sexual Function Questionnaire) was used to evaluate any changes in sexual function and activity, at Weeks 4, 8, 12 and 24. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. Erectile function domain has 6 questions with maximum score for domain is 30. Orgasmic function domain has 2 questions with maximum score for domain is 10. , Sexual desire function domain has 2 questions with maximum score for domain is 10. Intercourse satisfaction function domain has 3 questions with maximum score for domain is 15. Overall Satisfaction domain has 2 questions with maximum score for domain is 10. A higher score indicated a worse outcome in that domain.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12 and 24
    End point values
    		 P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
    Number of subjects analysed
    105
    97
    48
    Units: score on a scale
    arithmetic mean (standard error)
        Erectile Function Score, Week 4
    24.5 ± 0.76
    26.2 ± 0.79
    23.5 ± 1.08
        Erectile Function Score, Week 8
    24.3 ± 0.80
    24.9 ± 0.83
    24.4 ± 1.15
        Erectile Function Score, Week 12
    25.3 ± 0.73
    25.5 ± 0.77
    23.6 ± 1.04
        Erectile Function Score, Week 24
    25.3 ± 0.74
    26.1 ± 0.79
    24.9 ± 1.05
        Orgasmic Function Score, Week 4
    9.3 ± 0.21
    9.0 ± 0.22
    8.9 ± 0.30
        Orgasmic Function Score, Week 8
    8.7 ± 0.26
    8.7 ± 0.27
    9.1 ± 0.38
        Orgasmic Function Score, Week 12
    9.4 ± 0.21
    8.9 ± 0.22
    9.0 ± 0.30
        Orgasmic Function Score, Week 24
    8.9 ± 0.25
    9.1 ± 0.26
    9.0 ± 0.35
        Sexual Desire Score, Week 4
    7.3 ± 0.17
    7.5 ± 0.17
    7.1 ± 0.24
        Sexual Desire Score, Week 8
    7.4 ± 0.16
    7.4 ± 0.17
    7.6 ± 0.23
        Sexual Desire Score, Week 12
    7.7 ± 0.15
    8.0 ± 0.16
    7.8 ± 0.21
        Sexual Desire Score, Week 24
    7.7 ± 0.17
    7.7 ± 0.18
    7.8 ± 0.24
        Intercourse Satisfaction Score, Week 4
    9.4 ± 0.49
    10.7 ± 0.51
    8.5 ± 0.69
        Intercourse Satisfaction Score, Week 8
    9.6 ± 0.49
    9.9 ± 0.51
    9.0 ± 0.70
        Intercourse Satisfaction Score, Week 12
    9.9 ± 0.49
    10.2 ± 0.51
    8.3 ± 0.69
        Intercourse Satisfaction Score, Week 24
    9.8 ± 0.47
    10.8 ± 0.50
    8.9 ± 0.67
        Overall Satisfaction Score, Week 4
    7.9 ± 0.22
    8.0 ± 0.22
    7.9 ± 0.31
        Overall Satisfaction Score, Week 8
    7.9 ± 0.21
    7.8 ± 0.22
    7.8 ± 0.31
        Overall Satisfaction Score, Week 12
    8.1 ± 0.22
    8.1 ± 0.23
    7.6 ± 0.31
        Overall Satisfaction Score, Week 24
    8.0 ± 0.22
    8.1 ± 0.23
    8.2 ± 0.31
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Statistical Analysis details presented here is for Erectile Function Score, Week 4
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.103
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.03
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Statistical Analysis details presented here is for Erectile Function Score, Week 8
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.545
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Statistical Analysis details presented here is for Erectile Function Score, Week 12
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.842
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 1.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Statistical Analysis details presented here is for Erectile Function Score, Week 24
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.449
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.02
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Statistical Analysis details presented here is for Orgasmic Function Score, Week 4
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.272
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Statistical Analysis details presented here is for Orgasmic Function Score, Week 8
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.918
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.36
    Statistical analysis title
    		 Statistical Analysis 7
    Statistical analysis description
    Statistical Analysis details presented here is for Orgasmic Function Score, Week 12
    Comparison groups
    P-3074 Vehicle + Finasteride Placebo v P-3074 + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.078
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 1.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.078
    Statistical analysis title
    		 Statistical Analysis 8
    Statistical analysis description
    Statistical Analysis details presented here is for Orgasmic Function Score, Week 24
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.593
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34
    Statistical analysis title
    		 Statistical Analysis 9
    Statistical analysis description
    Statistical Analysis details presented here is for Sexual Desire Score, Week 4
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.295
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Statistical analysis title
    		 Statistical Analysis 10
    Statistical analysis description
    Statistical Analysis details presented here is for Sexual Desire Score, Week 8
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.926
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22
    Statistical analysis title
    		 Statistical Analysis 11
    Statistical analysis description
    Statistical Analysis details presented here is for Sexual Desire Score, Week 12
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.183
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Statistical analysis title
    		 Statistical Analysis 12
    Statistical analysis description
    Statistical Analysis details presented here is for Sexual Desire Score, Week 24
    Comparison groups
    P-3074 Vehicle + Finasteride Placebo v P-3074 + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.981
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Statistical analysis title
    		 Statistical Analysis 13
    Statistical analysis description
    Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 4
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.041
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.66
    Statistical analysis title
    		 Statistical Analysis 14
    Statistical analysis description
    Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 8
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.562
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.67
    Statistical analysis title
    		 Statistical Analysis 15
    Statistical analysis description
    Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 12
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.642
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.66
    Statistical analysis title
    		 Statistical Analysis 16
    Statistical analysis description
    Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 24
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.156
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.65
    Statistical analysis title
    		 Statistical Analysis 17
    Statistical analysis description
    Statistical Analysis details presented here is for Overall Satisfaction Score, Week 4
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.824
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Statistical Analysis 18
    Statistical analysis description
    Statistical Analysis details presented here is for Overall Satisfaction Score, Week 8
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.713
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Statistical Analysis 19
    Statistical analysis description
    Statistical Analysis details presented here is for Overall Satisfaction Score, Week 12
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.993
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Statistical analysis title
    		 Statistical Analysis 20
    Statistical analysis description
    Statistical Analysis details presented here is for Overall Satisfaction Score, Week 24
    Comparison groups
    P-3074 + Finasteride Placebo v P-3074 Vehicle + Finasteride Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.55
    Method
    		 Mixed linear model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3

    Secondary: Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale

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    End point title
    		 Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale
    End point description
    Local tolerability at the application site was assessed to rate the severity of any skin irritation. The Investigator used the Severity score for skin Irritation scale to assess local tolerability. The dermal response and other effects indicative irritation responses were recorded at time of examination. Anything other than “No evidence of irritation” under Dermal Response was considered as a Dermal Response Skin Irritation event. Anything other than “No other effects” under Other Effects was considered as an Other Effects of Skin Irritation event. The event incidence rate is calculated as the number of events interest divided by total personal time in years. Safety Population includes all randomized subjects who received at least one application of the IMP.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
    Number of subjects analysed
    181
    181
    84
    Units: Events per personal years
    number (not applicable)
        Dermal Response
    0.340
    0.245
    0.661
        Other Effects
    0.368
    0.463
    0.755
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
    End point description
    An Adverse event is defined as any untoward medical occurrence in a subjects or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect and medically significant event. The Treatment Emergent Adverse Events (TEAEs) is defined as all AEs occurring on or after the first dose of the IMP. Safety Population includes all randomized subjects who received at least one application of the IMP.
    End point type
    Secondary
    End point timeframe
    From the start of IMP upto 28 weeks
    End point values
    		 P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
    Number of subjects analysed
    181
    181
    84
    Units: Subjects
    number (not applicable)
        TEAEs
    75
    76
    41
        Serious TEAEs
    4
    5
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of the IMP up to 28 weeks
    Adverse event reporting additional description
    The data presented is for the safety population which includes all randomized subjects who received at least one application of the investigational medicinal product.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    P-3074 + Finasteride Placebo
    Reporting group description
    		 Subjects received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.

    Reporting group title
    Oral Finasteride + P-3074 Vehicle
    Reporting group description
    		 Subjects received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.

    Reporting group title
    P-3074 Vehicle + Finasteride Placebo
    Reporting group description
    		 Subjects received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.

    Serious adverse events
    		 P-3074 + Finasteride Placebo Oral Finasteride + P-3074 Vehicle P-3074 Vehicle + Finasteride Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 181 (2.21%)
    1 / 84 (1.19%)
    5 / 181 (2.76%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exposure via father
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Tendonitis
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 P-3074 + Finasteride Placebo Oral Finasteride + P-3074 Vehicle P-3074 Vehicle + Finasteride Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    74 / 181 (40.88%)
    40 / 84 (47.62%)
    73 / 181 (40.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Application site pruritus
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Chest discomfort
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Face oedema
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    3 / 181 (1.66%)
    1 / 84 (1.19%)
    1 / 181 (0.55%)
         occurrences all number
    4
    1
    2
    Thirst
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Dust allergy
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Social circumstances
    High risk sexual behaviour
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Stress at work
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Erectile dysfunction
         subjects affected / exposed
    2 / 181 (1.10%)
    2 / 84 (2.38%)
    2 / 181 (1.10%)
         occurrences all number
    2
    2
    2
    Sexual dysfunction
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    2 / 181 (1.10%)
         occurrences all number
    1
    0
    2
    Dyspnoea
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 181 (0.55%)
    3 / 84 (3.57%)
    7 / 181 (3.87%)
         occurrences all number
    1
    3
    7
    Nasal pruritus
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    2
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    1 / 181 (0.55%)
         occurrences all number
    0
    2
    1
    Burnout syndrome
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Depression
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    1
    Initial insomnia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    1
    0
    1
    Libido decreased
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 84 (1.19%)
    3 / 181 (1.66%)
         occurrences all number
    1
    1
    3
    Loss of libido
         subjects affected / exposed
    0 / 181 (0.00%)
    3 / 84 (3.57%)
    2 / 181 (1.10%)
         occurrences all number
    0
    3
    2
    Stress
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    1
    Blood bilirubin increased
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    2
    0
    0
    Blood bilirubin unconjugated increased
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Blood pressure systolic increased
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Blood uric acid increased
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Crystal urine present
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    1
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 84 (2.38%)
    0 / 181 (0.00%)
         occurrences all number
    0
    2
    0
    Liver function test increased
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Protein urine present
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Red blood cells urine positive
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Stress echocardiogram abnormal
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Weight increased
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    White blood cells urine positive
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Contusion
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Fall
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Foot fracture
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Injury
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Joint dislocation
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Laceration
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Ligament rupture
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Meniscus injury
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Skin injury
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Skin abrasion
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Upper limb fracture
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Sinus arrhythmia
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Cervicogenic headache
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    2 / 181 (1.10%)
         occurrences all number
    1
    0
    4
    Hyperaesthesia
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Head discomfort
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Presyncope
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Syncope
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    17 / 181 (9.39%)
    8 / 84 (9.52%)
    20 / 181 (11.05%)
         occurrences all number
    25
    9
    29
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    1
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    1
    0
    1
    Eye disorders
    Blepharitis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    1
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    1
    1
    0
    Anal pruritus
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Crohn’s disease
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Dental caries
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 181 (1.10%)
    2 / 84 (2.38%)
    2 / 181 (1.10%)
         occurrences all number
    2
    2
    2
    Dyspepsia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    2 / 181 (1.10%)
         occurrences all number
    0
    2
    3
    Dysphagia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Food poisoning
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Gastritis
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    2
    0
    1
    Inguinal hernia perforation
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    3 / 181 (1.66%)
         occurrences all number
    0
    0
    3
    Odynophagia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Toothache
         subjects affected / exposed
    3 / 181 (1.66%)
    2 / 84 (2.38%)
    3 / 181 (1.66%)
         occurrences all number
    3
    3
    3
    Vomiting
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    Hepatocellular injury
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermal cyst
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Diffuse alopecia
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Eczema
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Erythema
         subjects affected / exposed
    4 / 181 (2.21%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    5
    0
    0
    Papule
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    3
    0
    2
    Pruritus
         subjects affected / exposed
    5 / 181 (2.76%)
    1 / 84 (1.19%)
    1 / 181 (0.55%)
         occurrences all number
    5
    1
    3
    Pruritus generalised
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Rash papular
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    2
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Rash vesicular
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    2 / 181 (1.10%)
         occurrences all number
    0
    0
    2
    Sebaceous gland disorder
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Skin burning sensation
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Skin irritation
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Skin plaque
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Vitiligo
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Proteinuria
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Back pain
         subjects affected / exposed
    2 / 181 (1.10%)
    1 / 84 (1.19%)
    5 / 181 (2.76%)
         occurrences all number
    2
    1
    6
    Bone pain
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Bursitis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle tightness
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    2 / 181 (1.10%)
         occurrences all number
    1
    0
    2
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Anorectal infection
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    2 / 181 (1.10%)
         occurrences all number
    1
    0
    2
    Conjunctivitis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Epididymitis
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Gastritis helminthic
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 181 (1.10%)
    1 / 84 (1.19%)
    4 / 181 (2.21%)
         occurrences all number
    2
    1
    4
    Gastrointestinal infection
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    1
    1
    0
    Herpes simplex
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    2 / 181 (1.10%)
         occurrences all number
    0
    0
    2
    Infected bite
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    4 / 181 (2.21%)
    1 / 84 (1.19%)
    2 / 181 (1.10%)
         occurrences all number
    4
    1
    2
    Laryngitis
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 84 (1.19%)
    1 / 181 (0.55%)
         occurrences all number
    1
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    28 / 181 (15.47%)
    15 / 84 (17.86%)
    24 / 181 (13.26%)
         occurrences all number
    32
    22
    29
    Oral herpes
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    1
    Otitis externa
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Otitis media acute
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Periodontitis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Pertussis
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Pulpitis dental
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    1
    0
    1
    Rash pustular
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    1
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    3 / 181 (1.66%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    3
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 84 (1.19%)
    2 / 181 (1.10%)
         occurrences all number
    1
    1
    2
    Testicular abscess
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    3 / 181 (1.66%)
         occurrences all number
    0
    0
    4
    Tooth infection
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    3
    0
    1
    Viral infection
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 84 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 84 (1.19%)
    0 / 181 (0.00%)
         occurrences all number
    0
    1
    0
    Hypophosphataemia *
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 84 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    0
    1

    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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