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    Clinical Trial Results:
    Study FDC114615: Comparative efficacy of DuodartTM plus lifestyle advice versus watchful waiting plus lifestyle advice with step-up therapy to tamsulosin in the management of treatment naïve men with moderately symptomatic benign prostatic hyperplasia and prostate enlargement.

    Summary
    EudraCT number
    		 2010-022111-19
    Trial protocol
    		 DE   ES   NL   GB   FR   GR   IT  
    Global end of trial date
    17 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    03 Dec 2014
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FDC114615
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 866 435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 866 435-7343,
    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
    17 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of DUODART treatment plus lifestyle advice in providing superior symptomatic improvement to treatment naïve BPH subjects compared with watchful waiting plus lifestyle advice plus step-up therapy with tamsulosin.
    Protection of trial subjects
    Over nine visits after Baseline vital signs, clinical labs (chemistry and hematology) and review of adverse events were collected to monitor participants' safety. Lifestyle advice to manage systems of benign prostatic hyperplasia (BPH) was also provided.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Dec 2010
    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
    Netherlands: 50
    Country: Number of subjects enrolled
    Romania: 79
    Country: Number of subjects enrolled
    Spain: 117
    Country: Number of subjects enrolled
    United Kingdom: 18
    Country: Number of subjects enrolled
    France: 99
    Country: Number of subjects enrolled
    Germany: 175
    Country: Number of subjects enrolled
    Greece: 89
    Country: Number of subjects enrolled
    Italy: 115
    Worldwide total number of subjects
    742
    EEA total number of subjects
    742
    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)
    313
    From 65 to 84 years
    422
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Treatment-naïve men with symptomatic benign prostatic hyperplasia (BPH) meeting eligibility criteria were enrolled and were randomized in a 1:1 ratio to receive dutasteride plus tamsulosin once daily plus lifestyle advice or watchful waiting plus lifestyle advice.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dutasteride plus tamsulosin
    Arm description
    		 Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duodart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.5 mg dutasteride + 0.4 mg tamsulosin, orally once daily after the same meal each day with a full glass of water.

    Investigational medicinal product name
    Tamsulosin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.4 mg orally, once daily after the same meal each day with a full glass of water.

    Arm title
    		 Watchful Waiting All: Escalated Yes and No
    Arm description
    		 All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tamsulosin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.4 mg orally, once daily after the same meal each day with a full glass of water.

    Number of subjects in period 1
    		Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No
    Started
    369
    373
    Completed
    292
    300
    Not completed
    77
    73
         Consent withdrawn by subject
    28
    28
         Physician decision
    6
    11
         Adverse event, non-fatal
    28
    13
         Lost to follow-up
    7
    9
         Lack of efficacy
    7
    5
         Protocol deviation
    1
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dutasteride plus tamsulosin
    Reporting group description
    		 Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.

    Reporting group title
    Watchful Waiting All: Escalated Yes and No
    Reporting group description
    		 All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).

    Reporting group values
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No Total
    Number of subjects
    		 369 373 742
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.3 ( 7.78 ) 66.2 ( 7.34 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 369 373 742
    Race, Customized
    Units: Subjects
        White - White/Caucasian/European Heritage
    		 357 363 720
        White - Arabic/North African Heritage
    		 4 2 6
        African American/African Heritage
    		 0 2 2
        Mixed Race
    		 0 1 1
        Missing
    		 8 5 13

    End points

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    End points reporting groups
    Reporting group title
    Dutasteride plus tamsulosin
    Reporting group description
    		 Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.

    Reporting group title
    Watchful Waiting All: Escalated Yes and No
    Reporting group description
    		 All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).

    Subject analysis set title
    Watchful Waiting Escalated=Yes
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.

    Primary: Change from Baseline in the total International Prostate Symptom score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the last observation carried forward (LOCF) approach

    		 Close Top of page
    End point title
    		 Change from Baseline in the total International Prostate Symptom score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the last observation carried forward (LOCF) approach
    End point description
    The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates "delighted" and 6 indicates "terrible." The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from Baseline in IPSS total score was calculated as the Month 24 value minus the Baseline value. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
    End point type
    Primary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
    End point values
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No
    Number of subjects analysed
    359 [1]
    368 [2]
    Units: Scores on a scale
    least squares mean (standard error)
        Month 1, n=358, 367
    -3.2 ( 0.21 )
    -0.9 ( 0.2 )
        Month 3, n=359, 368
    -4.5 ( 0.22 )
    -2.4 ( 0.22 )
        Month 6, n=359, 368
    -4.6 ( 0.23 )
    -3.2 ( 0.22 )
        Month 9, n=359, 368
    -5.1 ( 0.22 )
    -3.6 ( 0.22 )
        Month 12, n=359, 368
    -5.2 ( 0.23 )
    -3.6 ( 0.23 )
        Month 15, n=359, 368
    -5.2 ( 0.25 )
    -3.6 ( 0.24 )
        Month 18, n=359, 368
    -5.1 ( 0.25 )
    -3.3 ( 0.25 )
        Month 21, n=359, 368
    -5.5 ( 0.25 )
    -3.6 ( 0.24 )
        Month 24, n=359, 368
    -5.4 ( 0.25 )
    -3.6 ( 0.25 )
    Notes
    [1] - Intent-to-Treat (ITT) Population
    [2] - Intent-to-Treat (ITT) Population
    Statistical analysis title
    		 Month 1
    Comparison groups
    Dutasteride plus tamsulosin v Watchful Waiting All: Escalated Yes and No
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001 [4]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 -1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Notes
    [3] - Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
    [4] - Values are based on t-tests from the general linear model.
    Statistical analysis title
    		 Month 3
    Comparison groups
    Dutasteride plus tamsulosin v Watchful Waiting All: Escalated Yes and No
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 < 0.001 [6]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 -1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.31
    Notes
    [5] - Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
    [6] - Values are based on t-tests from the general linear model.
    Statistical analysis title
    		 Month 6
    Comparison groups
    Dutasteride plus tamsulosin v Watchful Waiting All: Escalated Yes and No
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 < 0.001 [8]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 -0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.31
    Notes
    [7] - Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
    [8] - Values are based on t-tests from the general linear model.
    Statistical analysis title
    		 Month 9
    Comparison groups
    Dutasteride plus tamsulosin v Watchful Waiting All: Escalated Yes and No
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 < 0.001 [10]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.31
    Notes
    [9] - Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
    [10] - Values are based on t-tests from the general linear model.
    Statistical analysis title
    		 Month 12
    Comparison groups
    Dutasteride plus tamsulosin v Watchful Waiting All: Escalated Yes and No
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 < 0.001 [12]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.32
    Notes
    [11] - Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
    [12] - Values are based on t-tests from the general linear model.
    Statistical analysis title
    		 Month 15
    Comparison groups
    Dutasteride plus tamsulosin v Watchful Waiting All: Escalated Yes and No
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 < 0.001 [14]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34
    Notes
    [13] - Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
    [14] - Values are based on t-tests from the general linear model.
    Statistical analysis title
    		 Month 18
    Comparison groups
    Dutasteride plus tamsulosin v Watchful Waiting All: Escalated Yes and No
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 < 0.001 [16]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.35
    Notes
    [15] - Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
    [16] - Values are based on t-tests from the general linear model.
    Statistical analysis title
    		 Month 21
    Comparison groups
    Dutasteride plus tamsulosin v Watchful Waiting All: Escalated Yes and No
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 < 0.001 [18]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 -1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34
    Notes
    [17] - Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
    [18] - Values are based on t-tests from the general linear model.
    Statistical analysis title
    		 Month 24
    Comparison groups
    Dutasteride plus tamsulosin v Watchful Waiting All: Escalated Yes and No
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [19]
    P-value
    		 < 0.001 [20]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 -1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34
    Notes
    [19] - Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
    [20] - Values are based on t-tests from the general linear model.

    Secondary: Number of participants with change from Baseline in the indicated improvement categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach

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    End point title
    		 Number of participants with change from Baseline in the indicated improvement categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach
    End point description
    Symptom improvement was assessed using IPSS categorical changes from Baseline. Change from Baseline categories were summarized by treatment group using five improvement levels: >=1 point through >=5 points. IPSS percent change from Baseline was summarized using seven improvement levels: >0 percent, >=10 percent, >=20 percent, >=25 percent, >=30 percent, >=40 percent, and >=50 percent. Change in IPSS from Baseline was analysed using the LOCF method and is summarized for the following categories: >=2 points, >=3 points, and percent change >=25. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35).
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
    End point values
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No
    Number of subjects analysed
    359 [21]
    368 [22]
    Units: participants
        Month 1, >=2 points, n=358, 367
    225
    149
        Month 1, >=3 points, n=358, 367
    182
    90
        Month 1, >=25 percent, n=358, 367
    161
    76
        Month 3, >=2 points, n=359, 368
    277
    221
        Month 3, >=3 points, n=359, 368
    233
    172
        Month 3, >=25 percent, n= 359, 368
    218
    150
        Month 6, >=2 points, n=359, 368
    277
    250
        Month 6, >=3 points, n=359, 368
    245
    208
        Month 6, >=25 percent, n=359, 368
    229
    189
        Month 9, >=2 points, n=359, 368
    286
    276
        Month 9, >=3 points, n=359, 368
    257
    222
        Month 9, >=25 percent, n=359, 368
    247
    207
        Month 12, >=2 points, n=359, 368
    291
    273
        Month 12, >=3 points, n=359, 368
    261
    229
        Month 12, >=25 percent, n= 359, 368
    249
    214
        Month 15, >=2 points, n=359, 368
    289
    275
        Month 15, >=3 points, n=359, 368
    259
    243
        Month 15, >=25 percent, n=359, 368
    245
    231
        Month 18, >=2 points, n=359, 368
    288
    268
        Month 18, >=3 points, n=359, 368
    262
    229
        Month 18, >=25 percent, n=359, 368
    245
    212
        Month 21, >=2 points, n=359, 368
    292
    274
        Month 21, >=3 points, n=359, 368
    267
    237
        Month 21, >=25 percent, n= 359, 368
    253
    224
        Month 24, >=2 points, n=359, 368
    295
    279
        Month 24, >=3points, n=359, 368
    277
    234
        Month 24, >=25 percent, n= 359, 368
    261
    221
    Notes
    [21] - ITT Population
    [22] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in the BPH Impact Index (BII) score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach

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    End point title
    		 Change from Baseline in the BPH Impact Index (BII) score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach
    End point description
    The BII is a 4-item questionnaire covering physical discomfort, worry, bother, and impact on usual activities, with a minimum score of 0 (best) and a maximum score (worst) of 13 points. Individual missing questionnaire responses were imputed, as applicable. Change from Baseline in the BII score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline vaue minus the Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
    End point values
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No
    Number of subjects analysed
    359 [23]
    368 [24]
    Units: Scores on a scale
    least squares mean (standard error)
        Month 1, n=357, 366
    -1.3 ( 0.11 )
    -0.4 ( 0.11 )
        Month 3, n=359, 368
    -1.8 ( 0.11 )
    -1 ( 0.11 )
        Month 6, n=359, 368
    -1.9 ( 0.11 )
    -1.3 ( 0.11 )
        Month 9, n=359, 368
    -2.1 ( 0.11 )
    -1.5 ( 0.11 )
        Month 12, n=359, 368
    -2.1 ( 0.12 )
    -1.5 ( 0.12 )
        Month 15, n=359, 368
    -2.2 ( 0.12 )
    -1.5 ( 0.12 )
        Month 18, n=359, 368
    -2.2 ( 0.12 )
    -1.4 ( 0.12 )
        Month 21, n=359, 368
    -2.4 ( 0.12 )
    -1.6 ( 0.12 )
        Month 24, n=359, 368
    -2.4 ( 0.12 )
    -1.6 ( 0.12 )
    Notes
    [23] - ITT Population
    [24] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in the BPH-related Health Status (BHS) score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach

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    End point title
    		 Change from Baseline in the BPH-related Health Status (BHS) score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach
    End point description
    Each participant was asked the following question “If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?”. This response was rated from 0 (“delighted”) to 6 (“terrible”). Change from Baseline in the BHS score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
    End point values
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No
    Number of subjects analysed
    359 [25]
    368 [26]
    Units: Scores on a scale
    least squares mean (standard error)
        Month 1, n=358, 367
    -0.8 ( 0.06 )
    -0.3 ( 0.05 )
        Month 3, n=359, 368
    -1.1 ( 0.06 )
    -0.7 ( 0.06 )
        Month 6, n=359, 368
    -1.2 ( 0.06 )
    -0.9 ( 0.06 )
        Month 9, n=359, 368
    -1.3 ( 0.06 )
    -1 ( 0.06 )
        Month 12, n=359, 368
    -1.3 ( 0.06 )
    -1.1 ( 0.06 )
        Month 15, n=359, 368
    -1.4 ( 0.06 )
    -1.1 ( 0.06 )
        Month 18, n=359, 368
    -1.4 ( 0.06 )
    -1.1 ( 0.06 )
        Month 21, n=359, 368
    -1.5 ( 0.06 )
    -1.1 ( 0.06 )
        Month 24, n=359, 368
    -1.5 ( 0.06 )
    -1.1 ( 0.06 )
    Notes
    [25] - ITT Population
    [26] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of events of clinical progression (CP) of BPH

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    End point title
    		 Number of events of clinical progression (CP) of BPH
    End point description
    The number of participants with the first occurrence of clinical progression (CP) of BPH occurring on or after the randomization date are summarized by treatment and year. Time is based on the date of the first-occurring CP event, and is relative to the randomization date. CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom deterioration by IPSS >=3 points from Baseline (Visit 2); acute urinary retention related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). For components that required multiple episodes, the first of the multiple episodes was utilized in terms of timing.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No
    Number of subjects analysed
    369 [27]
    373 [28]
    Units: events
        Year 1, n=369, 373
    48
    94
        Year 2, n=276, 251
    17
    14
    Notes
    [27] - ITT Population. Only those participants at risk for CP at the specified visit were analyzed.
    [28] - ITT Population. Only those participants at risk for CP at the specified visit were analyzed.
    No statistical analyses for this end point

    Secondary: Number of participants who had any BPH-related surgery, who had the indicated type of surgery, who had 2 BPH-related surgeries, and who had >=3 BPH-related surgeries

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    End point title
    		 Number of participants who had any BPH-related surgery, who had the indicated type of surgery, who had 2 BPH-related surgeries, and who had >=3 BPH-related surgeries
    End point description
    BPH-related surgery was summarized for events occurring on or after the date of randomization. The number of participants who had any BPH-related surgery, the indicated type of surgery, and multiple surgeries was summarized by treatment. Type of surgery data (cystoscopy, transurethral resection of the prostate [TURP], and prostatectomy) are presented in terms of the first-occurring BPH-related surgery after randomization. It was possible for a single participant to have multiple surgeries.
    End point type
    Secondary
    End point timeframe
    Up to Month 24
    End point values
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No
    Number of subjects analysed
    369 [29]
    373 [30]
    Units: participants
        Participants with any BPH-related surgery
    6
    3
        Participants with cystoscopy
    5
    1
        Participants with TURP
    2
    1
        Participants with prostatectomy
    0
    1
        Participants with 2 surgeries
    1
    0
        Participants with >=3 surgeries
    0
    0
    Notes
    [29] - ITT Population
    [30] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated responses to Question 1 of the Patient Perception of Study Treatment (PPST) questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach

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    End point title
    		 Number of participants with the indicated responses to Question 1 of the Patient Perception of Study Treatment (PPST) questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach
    End point description
    The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 1 was: "Overall, how satisfied are you with the treatment and its effect on your urinary problems?" There were seven possible responses, including: "very satisfied," "satisfied," "somewhat satisfied," neutral," "somewhat dissatisfied," "dissatisfied," and "very dissatisfied." Response categories were created by grouping together "very satisfied," "satisfied," and "somewhat satisfied" responses into the category of "Any Satisfaction (AS)," and separately grouping "neutral," "somewhat dissatisfied," "dissatisfied," and "very dissatisfied" responses into the category of "Neutral or Any Dissatisfaction (N/AD)." The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
    End point values
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No
    Number of subjects analysed
    359 [31]
    364 [32]
    Units: participants
        Baseline, Any Satisfaction, n=315, 328
    119
    122
        Baseline, Neutral/Any Dissatisfaction, n=315, 328
    196
    206
        Month 1, Any Satisfaction, n=358, 349
    272
    209
        Month 1, Neutral/Any Dissatisfaction, n=358, 349
    86
    140
        Month 3, Any Satisfaction, n= 359, 359
    300
    265
        Month 3, Neutral/Any Dissatisfaction, n=359, 359
    59
    94
        Month 6, Any Satisfaction, n=359, 361
    301
    285
        Month 6, Neutral /Any Dissatisfaction, n=359, 361
    58
    76
        Month 9, Any Satisfaction, n=359, 361
    304
    293
        Month 9, Neutral/Any Dissatisfaction, n= 359, 361
    55
    68
        Month 12, Any Satisfaction, n=359, 363
    311
    305
        Month 12, Neutral/Any Dissatisfaction, n=359, 363
    48
    58
        Month 15, Any Satisfaction, n=359, 364
    311
    299
        Month 15, Neutral/Any Dissatisfaction, n=359, 364
    48
    65
        Month 18, Any Satisfaction, n=359, 364
    305
    298
        Month 18, Neutral/Any Dissatisfaction, n=359, 364
    54
    66
        Month 21, Any Satisfaction, n=359, 364
    310
    300
        Month 21, Neutral/Any Dissatisfaction, n=359, 364
    49
    64
        Month 24, Any Satisfaction, n=359, 364
    312
    312
        Month 24, Neutral/Any Dissatisfaction, n=359, 364
    47
    52
    Notes
    [31] - ITT Population
    [32] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated responses to Question 2 of the Patient Perception of Study Treatment (PPST) questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach

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    End point title
    		 Number of participants with the indicated responses to Question 2 of the Patient Perception of Study Treatment (PPST) questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach
    End point description
    The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 2 was: "Would you ask your doctor for the treatment you received in this study?" There were three possible responses, including: "Yes," "No," and "Not sure." Response categories included "Yes" and "No or Not Sure," created by grouping together "No" and "Not sure." The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
    End point values
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No
    Number of subjects analysed
    359 [33]
    364 [34]
    Units: participants
        Baseline, Yes, n=315, 328
    109
    103
        Baseline, No or Not Sure, n=315, 328
    206
    225
        Month 1, Yes, n=358, 347
    224
    166
        Month 1, No or Not Sure, n=358, 347
    134
    181
        Month 3, Yes, n=359, 357
    232
    207
        Month 3, No or Not Sure, n=359, 357
    127
    150
        Month 6, Yes, n=359, 360
    232
    227
        Month 6, No or Not Sure, n=359, 360
    127
    133
        Month 9, Yes, n=359, 361
    238
    231
        Month 9, No or Not Sure, n=359, 361
    121
    130
        Month 12, Yes, n=359, 363
    240
    229
        Month 12, No or Not Sure, n=359, 363
    119
    134
        Month 15, Yes, n=359, 364
    246
    239
        Month 15, No or Not Sure, n=359, 364
    113
    125
        Month 18, Yes, n=359, 364
    235
    236
        Month 18, No or Not Sure, n=359, 364
    124
    128
        Month 21, Yes, n=359, 364
    249
    234
        Month 21, No or Not Sure, n=359, 364
    110
    130
        Month 24, Yes, n=359, 364
    243
    236
        Month 24, No or Not Sure, n=359, 364
    116
    128
    Notes
    [33] - ITT Population
    [34] - ITT Population
    No statistical analyses for this end point

    Secondary: Exposure to study drug

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    End point title
    		 Exposure to study drug
    End point description
    Study drug exposure (days) = treatment stop date - treatment start date + 1. Participants in the Watchful Waiting Escalated=Yes subgroup could have been escalated to study drug at any time during the study. Therefore, it is possible that participants were exposed to tamsulosin for a shorter length of time than participants in the dutasteride plus tamsulosin group.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No
    Number of subjects analysed
    368 [35]
    229 [36]
    Units: days
        arithmetic mean (standard deviation)
    639.8 ( 215.49 )
    566.3 ( 195.13 )
    Notes
    [35] - Treated Subjects Population
    [36] - Treated Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated first-occurring component of clinical progression (CP) of BPH

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    End point title
    		 Number of participants with the indicated first-occurring component of clinical progression (CP) of BPH
    End point description
    CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom progression (symptom deterioration by IPSS >=3 points from Baseline [Visit 2]); acute urinary retention (AUR) related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). The number of participants with CP of BPH, the number of participants with the indicated first-occurring component of CP of BPH, the number of participants with two simultaneously first-occurring components ("Tied for first component"), and the number of participants with multiple first-occurring components were summarized by treatment group.
    End point type
    Secondary
    End point timeframe
    Up to Month 24
    End point values
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No
    Number of subjects analysed
    369 [37]
    373 [38]
    Units: participants
        Participants with CP of BPH, n=369, 373
    65
    108
        BPH symptom progression, n=65, 108
    59
    97
        BPH-related AUR, n=65, 108
    2
    4
        BPH-related incontinence, n=65, 108
    4
    3
        Recurrent BPH-related UTI, n=65, 108
    0
    4
        BPH-related renal insufficiency, n=65, 108
    0
    0
        Tied for first component, n=65, 108
    0
    0
        2 components, n=65, 108
    4
    9
        3 components, n=65, 108
    0
    1
        >=4 components, n=65, 108
    0
    1
    Notes
    [37] - ITT Population
    [38] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with any adverse event (AE) or serious adverse event (SAE) starting post-randomization

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    End point title
    		 Number of participants with any adverse event (AE) or serious adverse event (SAE) starting post-randomization
    End point description
    A post-randomization adverse event is defined as an event with an onset on or after the randomization date or with a missing onset date. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general non-serious AE/SAE module for a list of non-serious AEs (occurring at a frequency threshold of >=5%) and SAEs.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No Watchful Waiting Escalated=Yes
    Number of subjects analysed
    369 [39]
    373 [40]
    229 [41]
    Units: participants
        Any AE
    190
    119
    95
        Any SAE
    38
    25
    19
    Notes
    [39] - ITT Population
    [40] - ITT Population
    [41] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious adverse events (AEs) starting post-randomization (including events with an onset on or after the randomization date or with a missing onset date) were collected (up to 2 years).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Dutasteride plus tamsulosin
    Reporting group description
    		 Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.

    Reporting group title
    Watchful Waiting All: Escalated Yes and No
    Reporting group description
    		 All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.

    Reporting group title
    Watchful Waiting Escalated=Yes
    Reporting group description
    		 All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.

    Serious adverse events
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No Watchful Waiting Escalated=Yes
    Total subjects affected by serious adverse events
         subjects affected / exposed
    38 / 369 (10.30%)
    25 / 373 (6.70%)
    19 / 229 (8.30%)
         number of deaths (all causes)
    0
    3
    2
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 369 (0.00%)
    2 / 373 (0.54%)
    2 / 229 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 369 (0.00%)
    2 / 373 (0.54%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    B-cell lymphoma
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Bronchial carcinoma
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Metastases to liver
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Myxoid liposarcoma
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Hypertension
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Death
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Pyrexia
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    1 / 369 (0.27%)
    2 / 373 (0.54%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         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 / 369 (0.27%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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 acidosis
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Investigations
    Transaminases increased
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Hip fracture
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Contusion
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Wound
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Lower limb fracture
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Post procedural haematuria
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Craniocerebral injury
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    4 / 369 (1.08%)
    2 / 373 (0.54%)
    2 / 229 (0.87%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 369 (0.27%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Aortic valve stenosis
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Atrioventricular block
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Cardiomyopathy
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Coronary artery disease
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Tachyarrhythmia
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Heart valve incompetence
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    0 / 229 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    2 / 369 (0.54%)
    0 / 373 (0.00%)
    0 / 229 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 369 (0.27%)
    1 / 373 (0.27%)
    0 / 229 (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
    Transient ischaemic attack
         subjects affected / exposed
    1 / 369 (0.27%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Sciatica
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia megaloblastic
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Lymphadenopathy
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Ulcerative keratitis
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    2 / 369 (0.54%)
    1 / 373 (0.27%)
    0 / 229 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Anal fistula
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Gastritis
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Ileus
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Pancreatitis
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Pancreatitis acute
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis necrotising
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Renal and urinary disorders
    Calculus bladder
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Arthritis
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    1 / 369 (0.27%)
    2 / 373 (0.54%)
    2 / 229 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 369 (0.54%)
    0 / 373 (0.00%)
    0 / 229 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 369 (0.00%)
    2 / 373 (0.54%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Pilonidal cyst
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Pneumonia
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 373 (0.00%)
    0 / 229 (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
    Infected cyst
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolic acidosis
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 373 (0.27%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dutasteride plus tamsulosin Watchful Waiting All: Escalated Yes and No Watchful Waiting Escalated=Yes
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 369 (11.65%)
    13 / 373 (3.49%)
    12 / 229 (5.24%)
    Reproductive system and breast disorders
    Retrograde ejaculation
         subjects affected / exposed
    19 / 369 (5.15%)
    10 / 373 (2.68%)
    10 / 229 (4.37%)
         occurrences all number
    19
    10
    10
    Erectile dysfunction
         subjects affected / exposed
    31 / 369 (8.40%)
    4 / 373 (1.07%)
    3 / 229 (1.31%)
         occurrences all number
    32
    4
    3

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jul 2011
    This amendment applied to all sites and all countries and was implemented after 496 participants had been randomized into the study. The changes in this amendment included adding an additional PSA test at Visit 5 and including some additional notes regarding the timing of biopsy.

    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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