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    Clinical Trial Results:
    A phase 3b, open-label pilot study to evaluate the safety and effectiveness of up to four treatment cycles of AA4500 in combination with the ErecAid® Esteem® Manual Vacuum Therapy System in men with Peyronie’s disease.

    Summary
    EudraCT number
    		 2013-005384-66
    Trial protocol
    		 GB  
    Global end of trial date
    09 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Dec 2016
    First version publication date
    01 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AUX-CC-807
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Auxilium Pharmaceuticals, LLC
    Sponsor organisation address
    1400 Atwater Drive, Malvern, United States, 19355
    Public contact
    Director, Regulatory Affairs, Endo Ventures Limited, 00353 1 268 2017, Walsh.Ciara@endo.com
    Scientific contact
    Director, Regulatory Affairs, Endo Ventures Limited, 00353 1 268 2017, Walsh.Ciara@endo.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
    09 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this study are to assess the safety and effectiveness of AA4500 in combination with the ErecAid® Esteem® Manual Vacuum Therapy System in improving curvature deformity in men with Peyronie’s disease.
    Protection of trial subjects
    Use of Vacuum System Prior to first use of the vacuum system, the Investigator or qualified designee instructed each subject in the proper usage of the ErecAid Esteem Manual Vacuum Therapy System. Each subject demonstrated to the Investigator/qualified designee that he could safely and correctly use the vacuum system before he was permitted to start therapy. Penile Anesthesia Before each injection of AA4500, the Investigator could administer a dorsal and/or a circumferential penile block according to the practice of his/her institution and the subject’s willingness to receive penile anesthesia. If preferred, topical anesthesia (eg, EMLA cream) could be applied before injection. Anesthesia was supplied by the Investigator and administered in accordance with the pharmacy practices at the institution. Care Procedures After Injection Immediately after injection, the Investigator or qualified designee (qualified by license, education, and training to perform the study procedure according to local, state, and country requirements) applied pressure to the injection site for 3 minutes and instructed the subject to continue applying pressure for another 5 minutes. Additionally, to evaluate the subject for possible immediate immunological AEs, the subject remained in direct observation of medical personnel who were skilled in the management of acute allergic reactions for the first 20 minutes after receiving an injection of study drug Because AA4500 is a foreign protein, an antibody response was measured in all subjects following treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Sep 2014
    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: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    22
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. Enrollment included 30 AA4500 naïve subjects who met the eligibility criteria.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AA4500 0.58 mg with Investigator Modeling
    Arm description
    		 2 injections separated by approximately 24 to 72 hours, repeated after 42 days (±5 days) for up to 4 treatment cycles Approximately 24 to 72 hours after the final injection of each treatment cycle the Investigator or qualified designee modeled the plaque. Fourteen days (+/- 2 days) after the second injection of each treatment cycle, subject would initiate use of the vacuum device twice daily until the next treatment visit; and through Week 24 after the last treatment cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    XIAFLEX/XIAPEX
    Investigational medicinal product code
    AA4500 (now EN3835)
    Other name
    Collagenase, Clostridium histolyticum
    Pharmaceutical forms
    Injection
    Routes of administration
    Intralesional use
    Dosage and administration details
    AA4500 was administered only after reconstitution with diluent (0.9% NaCl containing 0.03% calcium chloride). The volume of injection was 0.25 mL. AA4500 was injected directly into the primary penile plaque (at the point of maximal concavity as marked) of the flaccid penis according to instructions provided in the protocol. During each treatment cycle, subjects received 2 injections of study drug with approximately 24 to 72 hours between injections. Subjects could receive up to 4 treatment cycles; each cycle separated by 42 days (±5 days).

    Arm title
    		 AA4500 0.58 mg without Investigator Modeling
    Arm description
    		 2 injections separated by approximately 24 to 72 hours, repeated after 42 days (±5 days) for up to 4 treatment cycles. Fourteen days (+/- 2 days) after the second injection of each treatment cycle, subject would initiate use of the vacuum device twice daily until the next treatment visit; and through Week 24 after the last treatment cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    XIAFLEX/XIAPEX
    Investigational medicinal product code
    AA4500 (now EN3835)
    Other name
    Collagenase, Clostridium histolyticum
    Pharmaceutical forms
    Injection
    Routes of administration
    Intralesional use
    Dosage and administration details
    AA4500 was administered only after reconstitution with diluent (0.9% NaCl containing 0.03% calcium chloride). The volume of injection was 0.25 mL. AA4500 was injected directly into the primary penile plaque (at the point of maximal concavity as marked) of the flaccid penis according to instructions provided in the protocol. During each treatment cycle, subjects received 2 injections of study drug with approximately 24 to 72 hours between injections. Subjects could receive up to 4 treatment cycles; each cycle separated by 42 days (±5 days).

    Number of subjects in period 1
    		AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Started
    15
    15
    Completed
    15
    15
    Period 2
    Period 2 title
    Week 36
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AA4500 0.58 mg with Investigator Modeling
    Arm description
    		 2 injections separated by approximately 24 to 72 hours, repeated after 42 days (±5 days) for up to 4 treatment cycles Approximately 24 to 72 hours after the final injection of each treatment cycle the Investigator or qualified designee modeled the plaque. Fourteen days (+/- 2 days) after the second injection of each treatment cycle, subject would initiate use of the vacuum device twice daily until the next treatment visit; and through Week 24 after the last treatment cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    XIAFLEX/XIAPEX
    Investigational medicinal product code
    AA4500 (now EN3835)
    Other name
    Collagenase, Clostridium histolyticum
    Pharmaceutical forms
    Injection
    Routes of administration
    Intralesional use
    Dosage and administration details
    AA4500 was administered only after reconstitution with diluent (0.9% NaCl containing 0.03% calcium chloride). The volume of injection was 0.25 mL. AA4500 was injected directly into the primary penile plaque (at the point of maximal concavity as marked) of the flaccid penis according to instructions provided in the protocol. During each treatment cycle, subjects received 2 injections of study drug with approximately 24 to 72 hours between injections. Subjects could receive up to 4 treatment cycles; each cycle separated by 42 days (±5 days).

    Arm title
    		 AA4500 0.58 mg without Investigator Modeling
    Arm description
    		 2 injections separated by approximately 24 to 72 hours, repeated after 42 days (±5 days) for up to 4 treatment cycles. Fourteen days (+/- 2 days) after the second injection of each treatment cycle, subject would initiate use of the vacuum device twice daily until the next treatment visit; and through Week 24 after the last treatment cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    XIAFLEX/XIAPEX
    Investigational medicinal product code
    AA4500 (now EN3835)
    Other name
    Collagenase, Clostridium histolyticum
    Pharmaceutical forms
    Injection
    Routes of administration
    Intralesional use
    Dosage and administration details
    AA4500 was administered only after reconstitution with diluent (0.9% NaCl containing 0.03% calcium chloride). The volume of injection was 0.25 mL. AA4500 was injected directly into the primary penile plaque (at the point of maximal concavity as marked) of the flaccid penis according to instructions provided in the protocol. During each treatment cycle, subjects received 2 injections of study drug with approximately 24 to 72 hours between injections. Subjects could receive up to 4 treatment cycles; each cycle separated by 42 days (±5 days).

    Number of subjects in period 2
    		AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Started
    15
    15
    Completed
    13
    12
    Not completed
    2
    3
         Protocol deviation
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AA4500 0.58 mg with Investigator Modeling
    Reporting group description
    		 2 injections separated by approximately 24 to 72 hours, repeated after 42 days (±5 days) for up to 4 treatment cycles Approximately 24 to 72 hours after the final injection of each treatment cycle the Investigator or qualified designee modeled the plaque. Fourteen days (+/- 2 days) after the second injection of each treatment cycle, subject would initiate use of the vacuum device twice daily until the next treatment visit; and through Week 24 after the last treatment cycle.

    Reporting group title
    AA4500 0.58 mg without Investigator Modeling
    Reporting group description
    		 2 injections separated by approximately 24 to 72 hours, repeated after 42 days (±5 days) for up to 4 treatment cycles. Fourteen days (+/- 2 days) after the second injection of each treatment cycle, subject would initiate use of the vacuum device twice daily until the next treatment visit; and through Week 24 after the last treatment cycle.

    Reporting group values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling Total
    Number of subjects
    		 15 15 30
    Age categorical
    Units: Subjects
        < 45 years
    		 2 1 3
        45-64 years
    		 8 11 19
        65 years and over
    		 5 3 8
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.8 ( 9.37 ) 57.6 ( 8.44 ) -
    Gender categorical
    Units: Subjects
        Male
    		 15 15 30

    End points

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    End points reporting groups
    Reporting group title
    AA4500 0.58 mg with Investigator Modeling
    Reporting group description
    		 2 injections separated by approximately 24 to 72 hours, repeated after 42 days (±5 days) for up to 4 treatment cycles Approximately 24 to 72 hours after the final injection of each treatment cycle the Investigator or qualified designee modeled the plaque. Fourteen days (+/- 2 days) after the second injection of each treatment cycle, subject would initiate use of the vacuum device twice daily until the next treatment visit; and through Week 24 after the last treatment cycle.

    Reporting group title
    AA4500 0.58 mg without Investigator Modeling
    Reporting group description
    		 2 injections separated by approximately 24 to 72 hours, repeated after 42 days (±5 days) for up to 4 treatment cycles. Fourteen days (+/- 2 days) after the second injection of each treatment cycle, subject would initiate use of the vacuum device twice daily until the next treatment visit; and through Week 24 after the last treatment cycle.
    Reporting group title
    AA4500 0.58 mg with Investigator Modeling
    Reporting group description
    		 2 injections separated by approximately 24 to 72 hours, repeated after 42 days (±5 days) for up to 4 treatment cycles Approximately 24 to 72 hours after the final injection of each treatment cycle the Investigator or qualified designee modeled the plaque. Fourteen days (+/- 2 days) after the second injection of each treatment cycle, subject would initiate use of the vacuum device twice daily until the next treatment visit; and through Week 24 after the last treatment cycle.

    Reporting group title
    AA4500 0.58 mg without Investigator Modeling
    Reporting group description
    		 2 injections separated by approximately 24 to 72 hours, repeated after 42 days (±5 days) for up to 4 treatment cycles. Fourteen days (+/- 2 days) after the second injection of each treatment cycle, subject would initiate use of the vacuum device twice daily until the next treatment visit; and through Week 24 after the last treatment cycle.

    Primary: Percent Change from Baseline in Penile Curvature at Week 36 (LOCF)

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    End point title
    		 Percent Change from Baseline in Penile Curvature at Week 36 (LOCF)
    End point description
    Percent change from baseline in penile curvature at day 252/week 36. After administration of a PGE1 to induce an erection, the investigator or qualified designee measured the angle of penile deformity three times with a goniometer protractor device using a standard method. All three measurements had to be within 10° of each other; the most severe of the three findings was recorded.
    End point type
    Primary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    15
    15
    Units: % change from baseline
        arithmetic mean (standard deviation)
    -39.3 ( 13.21 )
    -41.1 ( 11.51 )
    Statistical analysis title
    		 Treatment comparison
    Statistical analysis description
    Treatment comparisons: Least square mean difference and its 95% CI
    Comparison groups
    AA4500 0.58 mg with Investigator Modeling v AA4500 0.58 mg without Investigator Modeling
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Difference of the means
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.5
         upper limit
    		 11
    Notes
    [1] - 95% CIs for the difference of means between treatment groups were estimated using analysis of variance (ANOVA) with a factor of treatment group. LOCF is the last known observation carried forward to week 36 if week 36 measurement was missing.

    Secondary: Change from Baseline in PDQ Peyronie’s Disease Bother Domain

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    End point title
    		 Change from Baseline in PDQ Peyronie’s Disease Bother Domain
    End point description
    Change from baseline in the Peyronie’s disease bother domain (PDQ questions 10-15). Each subject completed the PDQ questions 10-15.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    13
    11
    Units: PDQ Peyronie’s Disease Bother Domain
        arithmetic mean (standard deviation)
    -2.4 ( 2.53 )
    -3.8 ( 2.99 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PDQ Peyronie’s Disease Physical and Psychological Symptom Domain

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    End point title
    		 Change from Baseline in PDQ Peyronie’s Disease Physical and Psychological Symptom Domain
    End point description
    Change from baseline in severity of Peyronie’s disease physical and psychological symptom domain (PDQ questions 1-6). Each subject completed PDQ questions 1-6.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    13
    11
    Units: PDQ PD Physical and Psychological
        arithmetic mean (standard deviation)
    -2.2 ( 4.38 )
    -6.4 ( 2.8 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PDQ Penile Pain Domain

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    End point title
    		 Change from Baseline in PDQ Penile Pain Domain
    End point description
    Change from baseline in the penile pain domain (PDQ questions 7-9). Each subject completed PDQ questions 7-9.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    13
    11
    Units: PDQ Penile Pain Domain
        arithmetic mean (standard deviation)
    0.7 ( 3.07 )
    -1.3 ( 3 )
    No statistical analyses for this end point

    Secondary: Responder Analysis Based on Global Assessment of Peyronie’s Disease

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    End point title
    		 Responder Analysis Based on Global Assessment of Peyronie’s Disease
    End point description
    Responder analysis based on subject global assessment (a responder was a subject with a score of at least +1 on the subject global assessment). Each subject was asked to assess the overall change (much improved to much worse) in the symptoms and effects of Peyronie’s disease on his life.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    15
    13
    Units: Responder
        yes
    13
    12
        no
    2
    1
    No statistical analyses for this end point

    Secondary: Composite Responder Analysis Based on Penile Curvature and Peyronie’s Disease Bother Domain Score

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    End point title
    		 Composite Responder Analysis Based on Penile Curvature and Peyronie’s Disease Bother Domain Score
    End point description
    Composite responder analysis based on percentage change in penile curvature and change in PDQ bother score (a composite responder was a subject with a at least 20% reduction from baseline in penile curvature and 1 or more reduction in PDQ bother score).
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    15
    13
    Units: Composite Responders
        yes
    10
    11
        no
    5
    2
    No statistical analyses for this end point

    Secondary: Change from Baseline in Penile Plaque Consistency

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    End point title
    		 Change from Baseline in Penile Plaque Consistency
    End point description
    Change from baseline in penile plaque consistency. The investigator or qualified designee determined the consistency of the primary plaque in the flaccid penis as hard [solid] =5; firm throughout =4; moderate firmness =3; soft =2; or non-palpable =1. For non-homogeneous plaques, the investigator gave his/her opinion as to which of the categories listed above best describes the plaque.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    15
    15
    Units: Penile Plaque Consistency
        arithmetic mean (standard deviation)
    -0.4 ( 0.51 )
    -0.1 ( 0.52 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Penile Length

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    End point title
    		 Change from Baseline in Penile Length
    End point description
    The investigator or qualified designee measured the length of the stretched flaccid penis. The measurement was obtained by compressing the fat pad to the pubis and measuring dorsally on full stretch to the corona with a centimeter ruler.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    15
    15
    Units: Penile Length (cm)
        arithmetic mean (standard deviation)
    0.23 ( 0.598 )
    0.64 ( 0.579 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in IIEF Erectile Function

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    End point title
    		 Change from Baseline in IIEF Erectile Function
    End point description
    Change from baseline in erectile function domain score of the IIEF. Each of the 15 questions contained in the IIEF questionnaire were rated by the subject on a numerical scale of 0 (worst) to 5 (best).
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    13
    13
    Units: IIEF Domain total score
        arithmetic mean (standard deviation)
    -2.8 ( 10.42 )
    1.9 ( 5.5 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in IIEF Orgasmic Function

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    End point title
    		 Change from Baseline in IIEF Orgasmic Function
    End point description
    Change from baseline in orgasmic function domain score of the IIEF. Each of the 15 questions contained in the IIEF questionnaire were rated by the subject on a numerical scale of 0 (worst) to 5 (best).
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    15
    12
    Units: IIEF Domain Total Score
        arithmetic mean (standard deviation)
    -1 ( 4.11 )
    -0.3 ( 2.64 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in IIEF Sexual Desire

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    End point title
    		 Change from Baseline in IIEF Sexual Desire
    End point description
    Change from baseline in sexual desire domain score of the IIEF. Each of the 15 questions contained in the IIEF questionnaire were rated by the subject on a numerical scale of 0 (worst) to 5 (best).
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    15
    13
    Units: IIEF Domain Total Score
        arithmetic mean (standard deviation)
    -0.3 ( 1.62 )
    -0.1 ( 1.38 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in IIEF Intercourse Satisfaction

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    End point title
    		 Change from Baseline in IIEF Intercourse Satisfaction
    End point description
    Change from baseline in intercourse satisfaction domain score of the IIEF. Each of the 15 questions contained in the IIEF questionnaire were rated by the subject on a numerical scale of 0 (worst) to 5 (best).
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    14
    12
    Units: IIEF Domain Total Score
        arithmetic mean (standard deviation)
    -0.8 ( 4.46 )
    0.8 ( 5.45 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in IIEF Overall Satisfaction

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    End point title
    		 Change from Baseline in IIEF Overall Satisfaction
    End point description
    Change from baseline in overall satisfaction domain score of the IIEF. Each of the 15 questions contained in the IIEF questionnaire were rated by the subject on a numerical scale of 0 (worst) to 5 (best).
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    15
    13
    Units: IIEF Domain Total Score
        arithmetic mean (standard deviation)
    0.3 ( 1.79 )
    2 ( 2.61 )
    No statistical analyses for this end point

    Secondary: Direction of Penile Curvature

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    End point title
    		 Direction of Penile Curvature
    End point description
    The investigator or qualified designee determined the primary direction of penile curvature as right lateral, right dorsolateral, dorsal, left dorsolateral, or left lateral. Subjects with ventral curvature were excluded from the study.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    15
    15
    Units: participants
        Right Lateral
    1
    0
        Right Dorsolateral
    0
    0
        Dorsal
    5
    5
        Left Dorsolateral
    7
    7
        Left Lateral
    0
    0
        Ventral
    0
    0
        Not Done
    2
    3
    No statistical analyses for this end point

    Secondary: Number of Penile Plaques

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    End point title
    		 Number of Penile Plaques
    End point description
    The investigator or qualified designee located and documented the number of plaque(s) within the stretched flaccid penis.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    15
    15
    Units: participants
        None
    0
    0
        One
    11
    11
        Two
    1
    1
        More Than Two
    1
    0
        Not Done
    2
    3
    No statistical analyses for this end point

    Secondary: Penile Pain on Palpitation

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    End point title
    		 Penile Pain on Palpitation
    End point description
    The investigator or qualified designee documented penile pain on palpation of the flaccid penis as none, mild, moderate, or severe.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Number of subjects analysed
    15
    15
    Units: participants
        None
    13
    12
        Mild
    0
    0
        Moderate
    0
    0
        Severe
    0
    0
        Not Done
    2
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study, the Investigator monitored each subject for evidence of drug intolerance and for the development of clinical and/or laboratory evidence of an AE. An AE assessment was made by the Investigator on a routine basis throughout the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    AA4500 0.58 mg with Investigator Modeling
    Reporting group description
    		 -

    Reporting group title
    AA4500 0.58 mg without Investigator Modeling
    Reporting group description
    		 -

    Serious adverse events
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Pericarditis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AA4500 0.58 mg with Investigator Modeling AA4500 0.58 mg without Investigator Modeling
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    15 / 15 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Injection site swelling
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Nodule
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Local swelling
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Injection site pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Suprapubic pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Injection site bruising
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Needle issue
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Injection site discomfort
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Penile swelling
         subjects affected / exposed
    11 / 15 (73.33%)
    15 / 15 (100.00%)
         occurrences all number
    21
    29
    Penile pain
         subjects affected / exposed
    8 / 15 (53.33%)
    5 / 15 (33.33%)
         occurrences all number
    14
    6
    Penile erythema
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Erectile dysfunction
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Erection increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Dyspareunia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Scrotal haematocoele
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Penile blister
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Penile oedema
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Penis disorder
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Investigations
    Eosinophil count increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Penile contusion
         subjects affected / exposed
    13 / 15 (86.67%)
    15 / 15 (100.00%)
         occurrences all number
    29
    29
    Contusion
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 15 (13.33%)
         occurrences all number
    3
    2
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Skin discolouration
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Psoriasis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Upper respiratory tract infection
    Additional description: 1 occurrence of Upper respiratory tract infection in the AA4500 0.58 mg without Investigator Modeling group was a non-TEAE.
         subjects affected / exposed
    0 / 15 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    0
    4
    Conjunctivitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0

    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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