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Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

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ClinicalTrials.gov Identifier: NCT00384930
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : August 19, 2009
Last Update Posted : September 2, 2009
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Benign Prostatic Hyperplasia
Interventions Drug: tadalafil
Drug: placebo
Enrollment 1058
Recruitment Details  
Pre-assignment Details Prior to randomization, participants had a 1-4 week Screening/Wash-out Period, followed by a 4 week Placebo Run-In Period. 1813 participants were screened with 755 screen failures, and 1058 participants randomized. The two participants who did not receive study drug were not included in the baseline demographics table.
Arm/Group Title Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Hide Arm/Group Description placebo tablet by mouth once a day for twelve weeks 2.5 mg tadalafil tablet by mouth once a day for twelve weeks 5 mg tadalafil tablet by mouth once a day for twelve weeks 10 mg tadalafil tablet by mouth once a day for twelve weeks 20 mg tadalafil tablet by mouth once a day for twelve weeks
Period Title: Overall Study
Started 212 209 212 216 209
Received Double-Blind Study Drug 211 208 212 216 209
Completed 185 182 182 175 162
Not Completed 27 27 30 41 47
Reason Not Completed
Adverse Event             5             4             12             11             14
Entry Criteria Not Met             2             6             7             8             4
Lack of Efficacy             1             1             2             1             2
Lost to Follow-up             5             3             0             4             6
Physician Decision             0             1             1             0             1
Protocol Violation             1             0             1             6             4
Sponsor Decision             3             4             0             5             0
Withdrawal by Subject             9             7             7             6             16
Didn't Receive Double-Blind Study Drug             1             1             0             0             0
Arm/Group Title Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil Total
Hide Arm/Group Description placebo tablet by mouth once a day for twelve weeks 2.5 mg tadalafil tablet by mouth once a day for twelve weeks 5 mg tadalafil tablet by mouth once a day for twelve weeks 10 mg tadalafil tablet by mouth once a day for twelve weeks 20 mg tadalafil tablet by mouth once a day for twelve weeks Total of all reporting groups
Overall Number of Baseline Participants 211 208 212 216 209 1056
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 211 participants 208 participants 212 participants 216 participants 209 participants 1056 participants
61.75  (7.69) 62.03  (8.42) 61.95  (8.17) 62.22  (7.20) 62.55  (8.09) 62.10  (7.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants 208 participants 212 participants 216 participants 209 participants 1056 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
211
 100.0%
208
 100.0%
212
 100.0%
216
 100.0%
209
 100.0%
1056
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 211 participants 208 participants 212 participants 216 participants 209 participants 1056 participants
Australia 4 5 5 6 4 24
Canada 12 5 9 13 6 45
France 13 12 9 15 11 60
Germany 29 35 39 28 33 164
Greece 8 9 12 11 10 50
Italy 15 10 5 9 9 48
Mexico 19 16 17 19 19 90
Spain 3 3 2 5 4 17
Sweden 4 2 5 4 5 20
United States 105 112 109 106 108 540
Baseline (Visit 3) Lower Urinary Tract Symptoms (LUTS) Severity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 211 participants 208 participants 212 participants 216 participants 209 participants 1056 participants
Moderate (<20 units on a scale: IPSS) 137 139 141 143 141 701
Severe (>=20 units on a scale: IPSS) 74 69 71 72 68 354
Unknown 0 0 0 1 0 1
[1]
Measure Description: LUTS Severity was measured with the International Prostate Symptom Score (IPSS), which has a scoring range of 0 to 35. Total scores: 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Duration of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 211 participants 208 participants 212 participants 216 participants 209 participants 1056 participants
< 6 months 0 0 0 1 0 1
6 months to 1 year 44 27 37 27 39 174
1 year to 3 years 62 64 63 81 70 340
> 3 years 105 117 112 107 100 541
Erectile Dysfunction  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 211 participants 208 participants 212 participants 216 participants 209 participants 1056 participants
Yes 142 135 144 150 145 716
No 67 71 68 64 61 331
Unknown 1 2 0 2 3 8
Not Collected 1 0 0 0 0 1
Previous Therapy for Benign Prostatic Hyperplasia (BPH)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 211 participants 208 participants 212 participants 216 participants 209 participants 1056 participants
No 153 139 158 160 152 762
Yes 58 69 54 56 57 294
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 211 participants 208 participants 212 participants 216 participants 209 participants 1056 participants
African 3 3 7 5 5 23
Caucasian 179 184 179 186 176 904
East Asian 0 1 1 0 0 2
Hispanic 29 20 25 24 25 123
West Asian 0 0 0 1 3 4
Severity of Erectile Dysfunction (ED)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 211 participants 208 participants 212 participants 216 participants 209 participants 1056 participants
Mild 38 42 41 56 40 217
Moderate 82 75 82 72 79 390
Severe 22 18 21 22 26 109
[1]
Measure Description: Severity was determine only on participants with Erectile Dysfunction using scores on International Index of Erectile Function (IIEF) EF Domain (sum of the scores for Questions 1 through 5 and Question 15) with a range of 0 to 30. Normal EF (≥26), mild ED (17 to 25), moderate ED (11 to 16), and severe ED (1 to 10).
Sexually Active  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 211 participants 208 participants 212 participants 216 participants 209 participants 1056 participants
No 42 40 33 42 48 205
Yes 169 168 179 174 161 851
Sexually Active and Erectile Dysfunction (ED)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 211 participants 208 participants 212 participants 216 participants 209 participants 1056 participants
Sexually Active with ED 115 113 117 120 116 581
Sexually Active without ED 54 55 62 54 45 270
Not Sexually Active with ED 26 21 25 28 28 128
Not Sexually Active without ED 15 17 8 12 18 70
Sexual Activity and/or ED Status is Unknown 1 2 0 2 2 7
1.Primary Outcome
Title Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis
Hide Description Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Arm/Group Title Placebo 5 mg Tadalafil
Hide Arm/Group Description:
placebo tablet taken by mouth once a day for 12 weeks
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
Overall Number of Participants Analyzed 205 205
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 17.08  (6.36) 17.30  (5.97)
Change from Baseline -2.25  (6.17) -4.92  (5.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tadalafil
Comments This is the principal inferential analysis of the primary outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change = Endpoint minus Baseline.
Method Permutation Test
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis
Hide Description Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Arm/Group Title Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Hide Arm/Group Description:
placebo tablet by mouth once a day for twelve weeks
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
5 mg tadalafil tablet by mouth once a day for twelve weeks
10 mg tadalafil tablet by mouth once a day for twelve weeks
20 mg tadalafil tablet by mouth once a day for twelve weeks
Overall Number of Participants Analyzed 205 201 205 207 199
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.23  (0.49) -3.81  (0.50) -4.83  (0.49) -5.13  (0.48) -5.17  (0.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 2.5 mg Tadalafil
Comments This is a supportive analysis of the primary outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.58
Confidence Interval 95%
-2.68 to -0.48
Estimation Comments Mean Difference = 2.5 mg Tadalafil minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tadalafil
Comments This is a supportive analysis of the primary outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.60
Confidence Interval 95%
-3.69 to -1.51
Estimation Comments Mean Difference = 5 mg Tadalafil minus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tadalafil
Comments This is a supportive analysis of the primary outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.90
Confidence Interval 95%
-3.99 to -1.81
Estimation Comments Mean Difference = 10 mg Tadalafil minus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 20 mg Tadalafil
Comments This is a supportive analysis of the primary outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.94
Confidence Interval 95%
-4.04 to -1.84
Estimation Comments Mean Difference = 20 mg Tadalafil minus Placebo
3.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore
Hide Description Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Arm/Group Title Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Hide Arm/Group Description:
placebo tablet by mouth once a day for twelve weeks
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
5 mg tadalafil tablet by mouth once a day for twelve weeks
10 mg tadalafil tablet by mouth once a day for twelve weeks
20 mg tadalafil tablet by mouth once a day for twelve weeks
Overall Number of Participants Analyzed 205 201 205 208 199
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.58  (3.09) 7.78  (2.86) 7.65  (2.84) 7.88  (2.67) 7.53  (3.07)
Change from Baseline -0.99  (2.92) -1.62  (2.83) -1.91  (2.64) -2.04  (2.75) -2.05  (2.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 2.5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.57
Confidence Interval 95%
-1.08 to -0.07
Estimation Comments Mean Difference = 2.5 mg Tadalafil minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.90
Confidence Interval 95%
-1.40 to -0.40
Estimation Comments Mean Difference = 5 mg Tadalafil minus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.96
Confidence Interval 95%
-1.45 to -0.46
Estimation Comments Mean Difference = 10 mg Tadalafil minus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 20 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.07
Confidence Interval 95%
-1.58 to -0.57
Estimation Comments Mean Difference = 20 mg Tadalafil minus Placebo
4.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore
Hide Description Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Arm/Group Title Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Hide Arm/Group Description:
placebo tablet by mouth once a day for twelve weeks
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
5 mg tadalafil tablet by mouth once a day for twelve weeks
10 mg tadalafil tablet by mouth once a day for twelve weeks
20 mg tadalafil tablet by mouth once a day for twelve weeks
Overall Number of Participants Analyzed 205 202 205 207 199
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 9.51  (4.21) 9.71  (4.16) 9.65  (4.10) 9.88  (3.87) 9.57  (4.45)
Change from Baseline -1.27  (4.00) -2.31  (3.84) -3.00  (3.87) -3.29  (4.04) -3.17  (4.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 2.5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.97
Confidence Interval 95%
-1.69 to -0.26
Estimation Comments Mean Difference = 2.5 mg Tadalafil minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.69
Confidence Interval 95%
-2.40 to -0.98
Estimation Comments Mean Difference = 5 mg Tadalafil minus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.89
Confidence Interval 95%
-2.60 to -1.18
Estimation Comments Mean Difference = 10 mg Tadalafil minus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 20 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.87
Confidence Interval 95%
-2.59 to -1.15
Estimation Comments Mean Difference = 20 mg Tadalafil minus Placebo
5.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)
Hide Description Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia).
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Arm/Group Title Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Hide Arm/Group Description:
placebo tablet by mouth once a day for twelve weeks
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
5 mg tadalafil tablet by mouth once a day for twelve weeks
10 mg tadalafil tablet by mouth once a day for twelve weeks
20 mg tadalafil tablet by mouth once a day for twelve weeks
Overall Number of Participants Analyzed 205 201 205 208 199
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.36  (1.10) 2.37  (1.31) 2.36  (1.91) 2.36  (1.15) 2.20  (1.23)
Change from Baseline -0.36  (1.09) -0.43  (1.33) -0.49  (1.17) -0.43  (1.28) -0.54  (1.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 2.5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.503
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.07
Confidence Interval 95%
-0.28 to 0.14
Estimation Comments Mean Difference = 2.5 mg Tadalafil minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.206
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.13
Confidence Interval 95%
-0.34 to 0.07
Estimation Comments Mean Difference = 5 mg Tadalafil minus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.452
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.08
Confidence Interval 95%
-0.28 to 0.13
Estimation Comments Mean Difference = 10 mg Tadalafil minus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 20 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.26
Confidence Interval 95%
-0.47 to -0.06
Estimation Comments Mean Difference = 20 mg Tadalafil minus Placebo
6.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index
Hide Description Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Arm/Group Title Placebo 2.5 mg Tadalafil 5.0 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Hide Arm/Group Description:
placebo tablet by mouth once a day for twelve weeks
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
5.0 mg tadalafil tablet by mouth once a day for twelve weeks
10 mg tadalafil tablet by mouth once a day for twelve weeks
20 mg tadalafil tablet by mouth once a day for twelve weeks
Overall Number of Participants Analyzed 205 202 205 206 199
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.57  (1.19) 3.69  (1.19) 3.54  (1.30) 3.55  (1.23) 3.59  (1.28)
Change from Baseline -0.56  (1.20) -0.86  (1.13) -0.92  (1.30) -0.98  (1.46) -0.97  (1.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 2.5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.26
Confidence Interval 95%
-0.49 to -0.03
Estimation Comments Mean Difference = 2.5 mg Tadalafil minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 5.0 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.37
Confidence Interval 95%
-0.60 to -0.14
Estimation Comments Mean Difference = 5 mg Tadalafil minus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.43
Confidence Interval 95%
-0.66 to -0.19
Estimation Comments Mean Difference = 10 mg Tadalafil minus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 20 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.40
Confidence Interval 95%
-0.64 to -0.17
Estimation Comments Mean Difference = 20 mg Tadalafil minus Placebo
7.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)
Hide Description Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16.
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Arm/Group Title Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Hide Arm/Group Description:
placebo tablet by mouth once a day for twelve weeks
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
5 mg tadalafil tablet by mouth once a day for twelve weeks
10 mg tadalafil tablet by mouth once a day for twelve weeks
20 mg tadalafil tablet by mouth once a day for twelve weeks
Overall Number of Participants Analyzed 205 201 204 209 199
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 4.94  (2.95) 4.73  (2.95) 4.66  (2.98) 4.86  (2.98) 4.75  (2.79)
Change from Baseline -0.79  (2.52) -0.83  (2.66) -1.25  (2.75) -1.31  (2.79) -1.34  (2.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 2.5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.583
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.13
Confidence Interval 95%
-0.58 to 0.33
Estimation Comments Mean Difference = 2.5 mg Tadalafil minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.57
Confidence Interval 95%
-1.03 to -0.12
Estimation Comments Mean Difference = 5 mg Tadalafil minus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.55
Confidence Interval 95%
-1.00 to -0.10
Estimation Comments Mean Difference = 10 mg Tadalafil minus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 20 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.62
Confidence Interval 95%
-1.08 to -0.17
Estimation Comments Mean Difference = 20 mg Tadalafil minus Placebo
8.Secondary Outcome
Title Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)
Hide Description LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Arm/Group Title Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Hide Arm/Group Description:
placebo tablet by mouth once a day for twelve weeks
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
5 mg tadalafil tablet by mouth once a day for twelve weeks
10 mg tadalafil tablet by mouth once a day for twelve weeks
20 mg tadalafil tablet by mouth once a day for twelve weeks
Overall Number of Participants Analyzed 199 194 201 200 186
Measure Type: Number
Unit of Measure: participants
109 120 139 146 138
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 2.5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 20 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in Peak Urinary Flow
Hide Description Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values.
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.
Arm/Group Title Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Hide Arm/Group Description:
placebo tablet by mouth once a day for twelve weeks
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
5 mg tadalafil tablet by mouth once a day for twelve weeks
10 mg tadalafil tablet by mouth once a day for twelve weeks
20 mg tadalafil tablet by mouth once a day for twelve weeks
Overall Number of Participants Analyzed 198 201 202 201 190
Mean (Standard Deviation)
Unit of Measure: milliliter per second
Baseline 10.31  (4.85) 9.97  (4.09) 10.37  (3.86) 9.93  (3.77) 9.82  (3.97)
Change from Baseline 1.23  (5.01) 1.50  (4.56) 1.61  (3.95) 1.69  (4.46) 2.15  (4.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 2.5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.735
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.14
Confidence Interval 95%
-0.69 to 0.98
Estimation Comments Mean Difference = 2.5 mg Tadalafil minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.355
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.39
Confidence Interval 95%
-0.44 to 1.23
Estimation Comments Mean Difference = 5 mg Tadalafil minus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.433
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.34
Confidence Interval 95%
-0.50 to 1.17
Estimation Comments Mean Difference = 10 mg Tadalafil minus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 20 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.74
Confidence Interval 95%
-0.11 to 1.59
Estimation Comments Mean Difference = 20 mg Tadalafil minus Placebo
10.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain
Hide Description Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary continuous analyses were performed on an intent-to-treat basis. Data from all randomized and sexually active subjects with a history of ED and non-missing data at baseline and at least one postbaseline visit were used for the analysis. Last observation carried forward.
Arm/Group Title Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Hide Arm/Group Description:
placebo tablet by mouth once a day for twelve weeks
2.5 mg tadalafil tablet by mouth once a day for twelve weeks
5 mg tadalafil tablet by mouth once a day for twelve weeks
10 mg tadalafil tablet by mouth once a day for twelve weeks
20 mg tadalafil tablet by mouth once a day for twelve weeks
Overall Number of Participants Analyzed 113 109 113 113 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 17.26  (7.95) 17.42  (8.30) 15.29  (8.13) 17.22  (8.43) 16.28  (8.05)
Change from Baseline 0.78  (6.32) 3.97  (7.30) 6.56  (9.43) 6.64  (8.29) 7.44  (8.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 2.5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.36
Confidence Interval 95%
1.56 to 5.17
Estimation Comments Mean Difference = 2.5 mg Tadalafil minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 5 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.75
Confidence Interval 95%
2.95 to 6.54
Estimation Comments Mean Difference = 5 mg Tadalafil minus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.83
Confidence Interval 95%
4.04 to 7.62
Estimation Comments Mean Difference = 10 mg Tadalafil minus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 20 mg Tadalafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.15
Confidence Interval 95%
4.35 to 7.95
Estimation Comments Mean Difference = 20 mg Tadalafil minus Placebo
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Hide Arm/Group Description placebo tablet by mouth once a day for twelve weeks 2.5 mg tadalafil tablet by mouth once a day for twelve weeks 5 mg tadalafil tablet by mouth once a day for twelve weeks 10 mg tadalafil tablet by mouth once a day for twelve weeks 20 mg tadalafil tablet by mouth once a day for twelve weeks
All-Cause Mortality
Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6      3      1      2      5    
Cardiac disorders           
Angina unstable  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Atrial tachycardia  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Coronary artery stenosis  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Myocardial infarction  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Gastrointestinal disorders           
Pancreatitis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Hepatobiliary disorders           
Cholecystitis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Injury, poisoning and procedural complications           
Cartilage injury  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthritis  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 1/209 (0.48%)  1
Back pain  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Osteoarthritis  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Rheumatoid arthritis  1  1/212 (0.47%)  2 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Bladder neoplasm  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Nervous system disorders           
Cerebrovascular accident  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Renal and urinary disorders           
Nephrolithiasis  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Renal colic  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Renal failure acute  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Ureteric rupture  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Urinary retention  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Pulmonary embolism  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Surgical and medical procedures           
Coronary arterial stent insertion  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Indwelling catheter management  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Ureteral catheterisation  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Ureteral stent insertion  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo 2.5 mg Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg Tadalafil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43      54      65      75      80    
Cardiac disorders           
Arrhythmia  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Atrioventricular block second degree  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Cardiomegaly  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Left atrial dilatation  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Sinus arrhythmia  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Tachycardia  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 1/209 (0.48%)  1
Ear and labyrinth disorders           
Ear congestion  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Ear pain  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Tinnitus  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Vertigo  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  2 0/216 (0.00%)  0 1/209 (0.48%)  1
Endocrine disorders           
Hypothyroidism  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Eye disorders           
Choroidal neovascularisation  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Conjunctivitis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Eye irritation  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 1/209 (0.48%)  1
Eye pain  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Eyelid irritation  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Glaucoma  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Ocular hyperaemia  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Ocular hypertension  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Panophthalmitis  1  1/212 (0.47%)  2 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Photopsia  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Retinal tear  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  2 0/216 (0.00%)  0 0/209 (0.00%)  0
Vision blurred  1  1/212 (0.47%)  1 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Vitreous floaters  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain  1  0/212 (0.00%)  0 1/209 (0.48%)  1 1/212 (0.47%)  1 1/216 (0.46%)  1 1/209 (0.48%)  1
Abdominal pain lower  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Abdominal pain upper  1  2/212 (0.94%)  2 2/209 (0.96%)  3 2/212 (0.94%)  2 3/216 (1.39%)  3 0/209 (0.00%)  0
Bowel movement irregularity  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Constipation  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Diarrhoea  1  3/212 (1.42%)  3 2/209 (0.96%)  2 6/212 (2.83%)  12 1/216 (0.46%)  1 5/209 (2.39%)  5
Duodenogastric reflux  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Dyspepsia  1  0/212 (0.00%)  0 2/209 (0.96%)  3 10/212 (4.72%)  15 6/216 (2.78%)  6 10/209 (4.78%)  10
Flatulence  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 1/209 (0.48%)  1
Gastritis  1  1/212 (0.47%)  1 0/209 (0.00%)  0 1/212 (0.47%)  1 3/216 (1.39%)  3 2/209 (0.96%)  2
Gastrooesophageal reflux disease  1  0/212 (0.00%)  0 2/209 (0.96%)  2 2/212 (0.94%)  2 6/216 (2.78%)  6 3/209 (1.44%)  3
Gingival disorder  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Haemorrhoids  1  1/212 (0.47%)  1 1/209 (0.48%)  1 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Hiatus hernia  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Inguinal hernia  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Nausea  1  1/212 (0.47%)  1 0/209 (0.00%)  0 3/212 (1.42%)  3 0/216 (0.00%)  0 0/209 (0.00%)  0
Oesophageal pain  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Oesophagitis  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Rectal haemorrhage  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Reflux oesophagitis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 1/209 (0.48%)  1
Stomach discomfort  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Tooth loss  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Toothache  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Vomiting  1  1/212 (0.47%)  1 0/209 (0.00%)  0 3/212 (1.42%)  3 0/216 (0.00%)  0 1/209 (0.48%)  1
General disorders           
Asthenia  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Chest discomfort  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Chest pain  1  0/212 (0.00%)  0 0/209 (0.00%)  0 3/212 (1.42%)  3 0/216 (0.00%)  0 0/209 (0.00%)  0
Fatigue  1  1/212 (0.47%)  1 0/209 (0.00%)  0 1/212 (0.47%)  1 1/216 (0.46%)  1 0/209 (0.00%)  0
Inflammation  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Influenza like illness  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Irritability  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Local swelling  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Oedema  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 1/216 (0.46%)  1 0/209 (0.00%)  0
Oedema peripheral  1  0/212 (0.00%)  0 1/209 (0.48%)  1 1/212 (0.47%)  1 2/216 (0.93%)  2 0/209 (0.00%)  0
Pain  1  0/212 (0.00%)  0 1/209 (0.48%)  1 2/212 (0.94%)  2 0/216 (0.00%)  0 1/209 (0.48%)  1
Pyrexia  1  1/212 (0.47%)  1 0/209 (0.00%)  0 2/212 (0.94%)  2 0/216 (0.00%)  0 1/209 (0.48%)  1
Sensation of foreign body  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 2/209 (0.96%)  2
Hepatobiliary disorders           
Hepatic function abnormal  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Immune system disorders           
Hypersensitivity  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 1/209 (0.48%)  1
Seasonal allergy  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  2 0/216 (0.00%)  0 1/209 (0.48%)  1
Infections and infestations           
Bronchitis  1  1/212 (0.47%)  1 3/209 (1.44%)  3 1/212 (0.47%)  1 5/216 (2.31%)  5 0/209 (0.00%)  0
Cystitis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Diverticulitis  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Ear infection  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Folliculitis  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Fungal infection  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Gastroenteritis  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Gastroenteritis viral  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 2/216 (0.93%)  2 1/209 (0.48%)  1
Herpes simplex  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Herpes zoster  1  1/212 (0.47%)  1 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 2/209 (0.96%)  2
Influenza  1  1/212 (0.47%)  1 4/209 (1.91%)  4 4/212 (1.89%)  4 1/216 (0.46%)  1 2/209 (0.96%)  2
Labyrinthitis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Lower respiratory tract infection  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Nasopharyngitis  1  2/212 (0.94%)  2 7/209 (3.35%)  8 4/212 (1.89%)  6 2/216 (0.93%)  2 5/209 (2.39%)  5
Pharyngitis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 2/216 (0.93%)  2 0/209 (0.00%)  0
Pneumonia viral  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Rhinitis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Sinusitis  1  1/212 (0.47%)  1 1/209 (0.48%)  1 0/212 (0.00%)  0 1/216 (0.46%)  1 1/209 (0.48%)  1
Tooth abscess  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Tracheitis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Upper respiratory tract infection  1  2/212 (0.94%)  2 0/209 (0.00%)  0 2/212 (0.94%)  2 0/216 (0.00%)  0 1/209 (0.48%)  1
Urinary tract infection  1  3/212 (1.42%)  3 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Injury, poisoning and procedural complications           
Animal bite  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Back injury  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 1/209 (0.48%)  1
Excoriation  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Fall  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Foot fracture  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Joint sprain  1  0/212 (0.00%)  0 2/209 (0.96%)  2 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Ligament sprain  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Limb injury  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Skeletal injury  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Tendon injury  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Thermal burn  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Tibia fracture  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Vertebral injury  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Wound  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  2 0/216 (0.00%)  0 0/209 (0.00%)  0
Investigations           
Arthroscopy  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Blood creatine phosphokinase increased  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Cardiac murmur  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Gamma-glutamyltransferase increased  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Heart rate abnormal  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Heart rate irregular  1  0/212 (0.00%)  0 1/209 (0.48%)  2 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Hepatic enzyme increased  1  1/212 (0.47%)  1 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Prostatic specific antigen increased  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Weight increased  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Metabolism and nutrition disorders           
Decreased appetite  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Gout  1  0/212 (0.00%)  0 0/209 (0.00%)  0 3/212 (1.42%)  3 1/216 (0.46%)  1 0/209 (0.00%)  0
Hypercholesterolaemia  1  0/212 (0.00%)  0 1/209 (0.48%)  1 1/212 (0.47%)  1 0/216 (0.00%)  0 1/209 (0.48%)  1
Hyperkalaemia  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Hyperlipidaemia  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 2/209 (0.96%)  2
Hyponatraemia  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Obesity  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Podagra  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 1/209 (0.48%)  1
Arthritis  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Back pain  1  1/212 (0.47%)  1 3/209 (1.44%)  3 2/212 (0.94%)  3 10/216 (4.63%)  10 11/209 (5.26%)  13
Bone pain  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Bursitis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Exostosis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Intervertebral disc protrusion  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 2/216 (0.93%)  2 0/209 (0.00%)  0
Joint stiffness  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Joint swelling  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Limb discomfort  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Muscle spasms  1  0/212 (0.00%)  0 2/209 (0.96%)  2 0/212 (0.00%)  0 2/216 (0.93%)  2 5/209 (2.39%)  6
Musculoskeletal chest pain  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Musculoskeletal pain  1  2/212 (0.94%)  2 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 1/209 (0.48%)  1
Musculoskeletal stiffness  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Myalgia  1  0/212 (0.00%)  0 3/209 (1.44%)  4 3/212 (1.42%)  3 6/216 (2.78%)  6 6/209 (2.87%)  7
Osteoarthritis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Pain in extremity  1  0/212 (0.00%)  0 3/209 (1.44%)  5 5/212 (2.36%)  5 2/216 (0.93%)  2 3/209 (1.44%)  3
Rotator cuff syndrome  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Spinal osteoarthritis  1  1/212 (0.47%)  1 1/209 (0.48%)  1 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Tendonitis  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Bile duct cancer  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Nervous system disorders           
Burning sensation  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 1/209 (0.48%)  1
Dizziness  1  1/212 (0.47%)  1 0/209 (0.00%)  0 1/212 (0.47%)  1 1/216 (0.46%)  1 3/209 (1.44%)  3
Headache  1  6/212 (2.83%)  6 5/209 (2.39%)  5 6/212 (2.83%)  7 11/216 (5.09%)  11 7/209 (3.35%)  8
Hypoaesthesia  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Lethargy  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Nerve compression  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Neuralgia  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Neuropathy peripheral  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Paraesthesia  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Sciatica  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 1/209 (0.48%)  1
Somnolence  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Syncope  1  0/212 (0.00%)  0 2/209 (0.96%)  3 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Psychiatric disorders           
Anxiety  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Depression  1  0/212 (0.00%)  0 1/209 (0.48%)  1 2/212 (0.94%)  2 1/216 (0.46%)  1 0/209 (0.00%)  0
Insomnia  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 2/216 (0.93%)  2 0/209 (0.00%)  0
Sleep disorder  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Renal and urinary disorders           
Bladder spasm  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Dysuria  1  0/212 (0.00%)  0 1/209 (0.48%)  1 1/212 (0.47%)  1 0/216 (0.00%)  0 1/209 (0.48%)  1
Nocturia  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 1/216 (0.46%)  1 1/209 (0.48%)  1
Pollakiuria  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 1/209 (0.48%)  1
Renal cyst  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Urinary hesitation  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Urine flow decreased  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Reproductive system and breast disorders           
Balanitis  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Breast pain  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  2 0/209 (0.00%)  0
Gynaecomastia  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Painful erection  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Asthma  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Cough  1  1/212 (0.47%)  1 3/209 (1.44%)  3 2/212 (0.94%)  2 2/216 (0.93%)  2 0/209 (0.00%)  0
Dyspnoea  1  0/212 (0.00%)  0 1/209 (0.48%)  1 2/212 (0.94%)  2 0/216 (0.00%)  0 1/209 (0.48%)  1
Epistaxis  1  0/212 (0.00%)  0 2/209 (0.96%)  2 2/212 (0.94%)  2 1/216 (0.46%)  1 0/209 (0.00%)  0
Nasal congestion  1  0/212 (0.00%)  0 0/209 (0.00%)  0 2/212 (0.94%)  2 2/216 (0.93%)  2 0/209 (0.00%)  0
Pharyngolaryngeal pain  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Pleurisy  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Rhinorrhoea  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Sinus congestion  1  0/212 (0.00%)  0 1/209 (0.48%)  1 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Sneezing  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Throat irritation  1  2/212 (0.94%)  2 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Skin and subcutaneous tissue disorders           
Dermatitis  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Eczema  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Photosensitivity reaction  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Pruritus  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  4 0/216 (0.00%)  0 1/209 (0.48%)  1
Rash  1  1/212 (0.47%)  1 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 2/209 (0.96%)  2
Skin irritation  1  2/212 (0.94%)  2 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Surgical and medical procedures           
Carpal tunnel decompression  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 0/216 (0.00%)  0 1/209 (0.48%)  1
Dental operation  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Sinus operation  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Tooth extraction  1  0/212 (0.00%)  0 1/209 (0.48%)  1 1/212 (0.47%)  1 0/216 (0.00%)  0 1/209 (0.48%)  1
Umbilical hernia repair  1  0/212 (0.00%)  0 0/209 (0.00%)  0 0/212 (0.00%)  0 1/216 (0.46%)  1 0/209 (0.00%)  0
Vascular disorders           
Blood pressure fluctuation  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Flushing  1  0/212 (0.00%)  0 1/209 (0.48%)  1 0/212 (0.00%)  0 0/216 (0.00%)  0 0/209 (0.00%)  0
Hot flush  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Hypertension  1  1/212 (0.47%)  1 0/209 (0.00%)  0 4/212 (1.89%)  4 1/216 (0.46%)  1 0/209 (0.00%)  0
Hypotension  1  0/212 (0.00%)  0 0/209 (0.00%)  0 1/212 (0.47%)  1 0/216 (0.00%)  0 0/209 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 1-800-545-5979
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00384930     History of Changes
Other Study ID Numbers: 9797
H6D-MC-LVHG
First Submitted: October 3, 2006
First Posted: October 6, 2006
Results First Submitted: October 17, 2008
Results First Posted: August 19, 2009
Last Update Posted: September 2, 2009