Trial Outcomes & Findings for A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia (NCT NCT00855582)
NCT ID: NCT00855582
Last Updated: 2011-07-28
Results Overview
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
COMPLETED
PHASE3
606 participants
Baseline, 12 weeks
2011-07-28
Participant Flow
There is a 4-week washout during Screening in order to assess symptoms and uroflowmetry data in the absence of therapy. After the screening/washout period, subjects began a 4-week single-blind, placebo lead-in period to assess treatment and study procedure compliance and to establish baseline levels.
Participant milestones
| Measure |
Tadalafil 2.5 mg
2.5 mg tablet once daily by mouth for 12 weeks.
|
Tadalafil 5 mg
5 mg tablet once daily by mouth for 12 weeks.
|
Placebo
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
198
|
208
|
200
|
|
Overall Study
COMPLETED
|
172
|
184
|
170
|
|
Overall Study
NOT COMPLETED
|
26
|
24
|
30
|
Reasons for withdrawal
| Measure |
Tadalafil 2.5 mg
2.5 mg tablet once daily by mouth for 12 weeks.
|
Tadalafil 5 mg
5 mg tablet once daily by mouth for 12 weeks.
|
Placebo
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
6
|
3
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
3
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
6
|
2
|
6
|
|
Overall Study
Entry Criteria Not Met
|
8
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
8
|
Baseline Characteristics
A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia
Baseline characteristics by cohort
| Measure |
Tadalafil 2.5 mg
n=198 Participants
2.5 mg tablet once daily by mouth for 12 weeks.
|
Tadalafil 5 mg
n=208 Participants
5 mg tablet once daily by mouth for 12 weeks.
|
Placebo
n=200 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Total
n=606 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
62.2 years
STANDARD_DEVIATION 7.56 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 8.43 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 8.23 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 8.08 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
198 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
606 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
512 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
181 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
565 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
17 participants
n=5 Participants
|
24 participants
n=7 Participants
|
21 participants
n=5 Participants
|
62 participants
n=4 Participants
|
|
Region of Enrollment
Portugal
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
71 participants
n=7 Participants
|
68 participants
n=5 Participants
|
210 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
22 participants
n=5 Participants
|
76 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
22 participants
n=5 Participants
|
23 participants
n=7 Participants
|
26 participants
n=5 Participants
|
71 participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
21 participants
n=5 Participants
|
29 participants
n=7 Participants
|
25 participants
n=5 Participants
|
75 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
9 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
27.7 kg/m²
STANDARD_DEVIATION 3.86 • n=5 Participants
|
28.0 kg/m²
STANDARD_DEVIATION 4.18 • n=7 Participants
|
28.6 kg/m²
STANDARD_DEVIATION 4.8 • n=5 Participants
|
28.1 kg/m²
STANDARD_DEVIATION 4.3 • n=4 Participants
|
|
Lower Urinary Tract Symptoms (LUTS) Severity
Moderate (IPSS <20)
|
123 participants
n=5 Participants
|
124 participants
n=7 Participants
|
122 participants
n=5 Participants
|
369 participants
n=4 Participants
|
|
Lower Urinary Tract Symptoms (LUTS) Severity
Severe (IPSS ≥20)
|
74 participants
n=5 Participants
|
84 participants
n=7 Participants
|
78 participants
n=5 Participants
|
236 participants
n=4 Participants
|
|
Lower Urinary Tract Symptoms (LUTS) Severity
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Peak Urine Flow Rate (Qmax)
<10 mL/sec
|
96 participants
n=5 Participants
|
87 participants
n=7 Participants
|
99 participants
n=5 Participants
|
282 participants
n=4 Participants
|
|
Peak Urine Flow Rate (Qmax)
10-15 mL/sec
|
73 participants
n=5 Participants
|
83 participants
n=7 Participants
|
66 participants
n=5 Participants
|
222 participants
n=4 Participants
|
|
Peak Urine Flow Rate (Qmax)
>15mL/sec
|
21 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
53 participants
n=4 Participants
|
|
Peak Urine Flow Rate (Qmax)
Unknown
|
8 participants
n=5 Participants
|
22 participants
n=7 Participants
|
19 participants
n=5 Participants
|
49 participants
n=4 Participants
|
|
Postvoid Residual Volume (PRV)
|
53.0 mL
STANDARD_DEVIATION 51.24 • n=5 Participants
|
51.1 mL
STANDARD_DEVIATION 60.91 • n=7 Participants
|
55.5 mL
STANDARD_DEVIATION 60.46 • n=5 Participants
|
53.2 mL
STANDARD_DEVIATION 57.72 • n=4 Participants
|
|
Erectile Dysfunction (ED) - Etiology
Psychogenic
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
12 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Erectile Dysfunction (ED) - Etiology
Organic
|
65 participants
n=5 Participants
|
70 participants
n=7 Participants
|
85 participants
n=5 Participants
|
220 participants
n=4 Participants
|
|
Erectile Dysfunction (ED) - Etiology
Mixed
|
76 participants
n=5 Participants
|
83 participants
n=7 Participants
|
63 participants
n=5 Participants
|
222 participants
n=4 Participants
|
|
Erectile Dysfunction (ED) - Etiology
Unknown
|
44 participants
n=5 Participants
|
40 participants
n=7 Participants
|
40 participants
n=5 Participants
|
124 participants
n=4 Participants
|
|
ED - Severity
Mild (IIEF EF Domain 17-30)
|
104 participants
n=5 Participants
|
99 participants
n=7 Participants
|
93 participants
n=5 Participants
|
296 participants
n=4 Participants
|
|
ED - Severity
Moderate (IIEF EF Domain 11-16)
|
46 participants
n=5 Participants
|
54 participants
n=7 Participants
|
49 participants
n=5 Participants
|
149 participants
n=4 Participants
|
|
ED - Severity
Severe (IIEF EF Domain 1-10)
|
48 participants
n=5 Participants
|
55 participants
n=7 Participants
|
58 participants
n=5 Participants
|
161 participants
n=4 Participants
|
|
ED - Duration
<1 year
|
12 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
ED - Duration
≥1 year
|
186 participants
n=5 Participants
|
188 participants
n=7 Participants
|
181 participants
n=5 Participants
|
555 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=206 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=194 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)
|
-6.1 units on a scale
Standard Error 0.43
|
-3.8 units on a scale
Standard Error 0.45
|
—
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=203 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=190 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)
|
6.5 units on a scale
Standard Error 0.49
|
1.8 units on a scale
Standard Error 0.51
|
—
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=191 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=194 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)
|
-4.6 units on a scale
Standard Error 0.44
|
-3.8 units on a scale
Standard Error 0.45
|
—
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=190 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=190 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)
|
5.2 units on a scale
Standard Error 0.5
|
1.8 units on a scale
Standard Error 0.51
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value.
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of Yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=199 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=187 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)
|
31.7 percentage of Yes responses
Standard Error 2.07
|
12.0 percentage of Yes responses
Standard Error 2.14
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=203 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=190 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)
|
-2.1 units on scale
Standard Error 0.19
|
-1.2 units on scale
Standard Error 0.20
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value.
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=185 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=187 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)
|
24.6 percentage of yes responses
Standard Error 2.11
|
12.0 percentage of yes responses
Standard Error 2.14
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=190 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=190 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)
|
-1.6 units on a scale
Standard Deviation 0.20
|
-1.2 units on a scale
Standard Deviation 0.20
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
The Modified IPSS is the total IPSS collected at 2 weeks post-baseline. The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=148 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=160 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=162 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint
|
-2.8 units on a scale
Standard Error 0.39
|
-4.0 units on a scale
Standard Error 0.38
|
-2.2 units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=198 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=208 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=200 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint
Week 4 Change (n=184, 197, 183)
|
-3.4 units on a scale
Standard Error 0.39
|
-5.5 units on a scale
Standard Error 0.38
|
-2.6 units on a scale
Standard Error 0.40
|
|
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint
Week 8 Change (n=174, 192, 178)
|
-4.5 units on a scale
Standard Error 0.43
|
-5.8 units on a scale
Standard Error 0.41
|
-3.8 units on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=198 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=208 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=200 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint
Week 4 Change (n=186, 197, 183)
|
4.2 units on a scale
Standard Error 0.44
|
6.1 units on a scale
Standard Error 0.43
|
1.0 units on a scale
Standard Error 0.45
|
|
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint
Week 8 Change (n=176, 192, 178)
|
4.9 units on a scale
Standard Error 0.49
|
6.6 units on a scale
Standard Error 0.48
|
1.8 units on a scale
Standard Error 0.52
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value.
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=198 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=208 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=200 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint
Week 4 Change (n=180, 190, 180)
|
22.3 percentage of yes responses
Standard Error 2.31
|
30.7 percentage of yes responses
Standard Error 2.27
|
6.2 percentage of yes responses
Standard Error 2.35
|
|
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint
Week 8 Change (n=172, 187, 171)
|
22.9 percentage of yes responses
Standard Error 2.16
|
31.7 percentage of yes responses
Standard Error 2.11
|
10.9 percentage of yes responses
Standard Error 2.21
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=198 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=208 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=200 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint
Week 4 Change (n=186, 197, 183)
|
-1.0 units on a scale
Standard Error 0.17
|
-1.5 units on a scale
Standard Error 0.16
|
-0.7 units on a scale
Standard Error 0.17
|
|
Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint
Week 8 Change (n=175, 192, 177)
|
-1.4 units on a scale
Standard Error 0.18
|
-1.8 units on a scale
Standard Error 0.17
|
-1.2 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. The obstructive subscore ranges from 0 to 20 with a higher score representing greater obstruction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=191 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=206 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=194 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint
|
-2.7 units on a scale
Standard Error 0.28
|
-3.6 units on a scale
Standard Error 0.28
|
-2.2 units on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. The irritative subscore ranges from 0 to 15 with a higher score representing more irritative symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=192 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=206 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=194 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint
|
-1.9 units on a scale
Standard Error 0.2
|
-2.5 units on a scale
Standard Error 0.19
|
-1.6 units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
The IPSS Nocturia question (Question 7) measures the number of times needed to get up at night to urinate. Scores range from 0 (none) to 5 (5 or more times). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=192 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=206 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=194 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12
|
-0.5 units on a scale
Standard Error 0.08
|
-0.6 units on a scale
Standard Error 0.07
|
-0.5 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
Assessment of quality of life (QoL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=192 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=205 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=194 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint
|
-0.9 units on a scale
Standard Error 0.10
|
-1.0 units on a scale
Standard Error 0.10
|
-0.8 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
Self-reported overall satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 13 and 14. Each question is scored from 1 through 5, with a possible total score of 2 through 10. Higher scores represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=190 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=203 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=190 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint
|
1.8 units on a scale
Standard Deviation 0.16
|
2.4 units on a scale
Standard Deviation 0.16
|
0.5 units on a scale
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
Self-reported intercourse satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 6, 7 and 8. Each question is scored from 0 through 5 with a possible total score of 0 through 15. Higher score represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=190 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=203 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=190 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint
|
1.6 units on a scale
Standard Deviation 0.23
|
2.0 units on a scale
Standard Deviation 0.22
|
0.2 units on a scale
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
IIEF Question 3 asks how often a subject was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=190 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=203 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=190 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint
|
0.9 units on a scale
Standard Error 0.10
|
1.1 units on a scale
Standard Error 0.10
|
0.2 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
IIEF Question 4 asks whether how often a subject was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=190 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=203 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=190 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint
|
0.9 units on a scale
Standard Error 0.11
|
1.3 units on a scale
Standard Error 0.10
|
0.4 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value.
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2, "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=185 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=199 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=187 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint
|
21.4 percentage of yes responses
Standard Error 1.82
|
25.1 percentage of yes responses
Standard Error 1.78
|
9.3 percentage of yes responses
Standard Error 1.84
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value.
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4, "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=185 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=199 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=187 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint
|
26.6 percentage of yes responses
Standard Error 2.48
|
39.4 percentage of yes responses
Standard Error 2.46
|
9.6 percentage of yes responses
Standard Error 2.61
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value.
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5, "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil 5 mg
n=185 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=199 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=187 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5
|
23.7 percentage of yes responses
Standard Error 2.49
|
38.2 percentage of yes responses
Standard Error 2.48
|
9.9 percentage of yes responses
Standard Error 2.63
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants started study medication, and had non-missing data.
A scale that measures the patient's perception of urinary symptoms at endpoint compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).
Outcome measures
| Measure |
Tadalafil 5 mg
n=185 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=197 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=185 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint
Very Much Worse
|
0 participants
|
0 participants
|
1 participants
|
|
Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint
Much Worse
|
3 participants
|
2 participants
|
4 participants
|
|
Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint
A Little Worse
|
12 participants
|
3 participants
|
13 participants
|
|
Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint
No Change
|
34 participants
|
34 participants
|
61 participants
|
|
Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint
A Little Better
|
66 participants
|
79 participants
|
63 participants
|
|
Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint
Much Better
|
57 participants
|
60 participants
|
37 participants
|
|
Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint
Very Much Better
|
13 participants
|
19 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants started study medication, and had non-missing data.
A scale that measures clinician's rating of the total change in the patient's urinary symptoms at endpoint compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).
Outcome measures
| Measure |
Tadalafil 5 mg
n=181 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=197 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=184 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint
Very Much Worse
|
0 participants
|
0 participants
|
1 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint
Much Worse
|
2 participants
|
1 participants
|
4 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint
A Little Worse
|
8 participants
|
2 participants
|
9 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint
No Change
|
41 participants
|
42 participants
|
64 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint
A Little Better
|
67 participants
|
60 participants
|
58 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint
Much Better
|
56 participants
|
78 participants
|
45 participants
|
|
Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint
Very Much Better
|
7 participants
|
14 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants started study medication, and had non-missing data.
The EF-GAQ consisted of two questions: (1) Has the treatment you have been taking during this study improved your erections? and (2) If yes, has the treatment improved your ability to engage in sexual activity? Each question has a Yes/No response.
Outcome measures
| Measure |
Tadalafil 5 mg
n=184 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=196 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=185 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Erectile Function General Assessment Questionnaire (EF-GAQ)
Question 1
|
135 participants with yes response
|
155 participants with yes response
|
74 participants with yes response
|
|
Erectile Function General Assessment Questionnaire (EF-GAQ)
Question 2
|
126 participants with yes response
|
146 participants with yes response
|
67 participants with yes response
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value.
Qmax is defined as the peak urine flow rate (measured in milliliters per second \[mL/sec\] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was \>=150 to \<=550 milliliters (mL) and the voided volume (Vcomp) was \>= 125 mL.
Outcome measures
| Measure |
Tadalafil 5 mg
n=157 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=160 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=143 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint
|
1.7 mL/sec
Standard Deviation 4.45
|
1.6 mL/sec
Standard Deviation 4.15
|
1.2 mL/sec
Standard Deviation 4.52
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value.
Qmean is defined as the average urine flow rate (measured in milliliters per second \[mL/second\] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was \>=150 to \<=550 milliliters (mL) and the voided volume (Vcomp) was \>= 125 mL.
Outcome measures
| Measure |
Tadalafil 5 mg
n=157 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=161 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=143 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint
|
1.0 mL/sec
Standard Deviation 2.65
|
0.9 mL/sec
Standard Deviation 2.92
|
0.6 mL/sec
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with non-missing baseline value and at least one non-missing post baseline value.
Vcomp is defined as the volume of urine voided (measures in mL using a standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was \>=150 to \<=550 milliliters (mL) and the voided volume (Vcomp) was \>= 125 mL.
Outcome measures
| Measure |
Tadalafil 5 mg
n=157 Participants
Tablet once daily by mouth for 12 weeks.
|
Placebo
n=161 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
Placebo
n=143 Participants
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint
|
18.5 mL
Standard Deviation 113.9
|
13.3 mL
Standard Deviation 92.75
|
11.4 mL
Standard Deviation 91.84
|
Adverse Events
Tadalafil 2.5 mg
Tadalafil 5 mg
Placebo
Serious adverse events
| Measure |
Tadalafil 2.5 mg
n=198 participants at risk
2.5 mg tablet once daily by mouth for 12 weeks.
|
Tadalafil 5 mg
n=208 participants at risk
5 mg tablet once daily by mouth for 12 weeks.
|
Placebo
n=200 participants at risk
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Gastrointestinal disorders
Pancreatitis haemorrhagic
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
Other adverse events
| Measure |
Tadalafil 2.5 mg
n=198 participants at risk
2.5 mg tablet once daily by mouth for 12 weeks.
|
Tadalafil 5 mg
n=208 participants at risk
5 mg tablet once daily by mouth for 12 weeks.
|
Placebo
n=200 participants at risk
Matching placebo tablet once daily by mouth for 12 weeks.
|
|---|---|---|---|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Vascular disorders
Flushing
|
0.51%
1/198 • Number of events 1
|
0.48%
1/208 • Number of events 1
|
0.50%
1/200 • Number of events 1
|
|
Vascular disorders
Hot flush
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Vascular disorders
Hypertension
|
0.00%
0/198
|
1.4%
3/208 • Number of events 3
|
0.50%
1/200 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Cardiac disorders
Palpitations
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Eye disorders
Cataract nuclear
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Eye disorders
Conjunctivitis
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Eye disorders
Dacryostenosis acquired
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Eye disorders
Photopsia
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Eye disorders
Retinal tear
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Eye disorders
Vision blurred
|
0.00%
0/198
|
0.96%
2/208 • Number of events 2
|
0.00%
0/200
|
|
Eye disorders
Vitreous detachment
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Eye disorders
Vitreous floaters
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.51%
1/198 • Number of events 1
|
0.96%
2/208 • Number of events 2
|
1.0%
2/200 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/198
|
0.48%
1/208 • Number of events 2
|
0.00%
0/200
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
2/198 • Number of events 2
|
0.48%
1/208 • Number of events 1
|
0.50%
1/200 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.51%
1/198 • Number of events 1
|
1.4%
3/208 • Number of events 3
|
0.00%
0/200
|
|
Gastrointestinal disorders
Food poisoning
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.50%
1/200 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Gastrointestinal disorders
Nausea
|
0.51%
1/198 • Number of events 1
|
0.48%
1/208 • Number of events 1
|
1.0%
2/200 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
General disorders
Chest pain
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
1.0%
2/200 • Number of events 2
|
|
General disorders
Influenza like illness
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
General disorders
Irritability
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
General disorders
Pain
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Immune system disorders
Allergy to arthropod sting
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Immune system disorders
Drug hypersensitivity
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Infections and infestations
Bronchitis
|
1.0%
2/198 • Number of events 2
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Infections and infestations
Ear infection
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Infections and infestations
Gastroenteritis viral
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Infections and infestations
Infected bites
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Infections and infestations
Influenza
|
2.0%
4/198 • Number of events 4
|
0.48%
1/208 • Number of events 1
|
2.5%
5/200 • Number of events 5
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Infections and infestations
Localised infection
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
6/198 • Number of events 6
|
2.4%
5/208 • Number of events 5
|
2.0%
4/200 • Number of events 4
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/198
|
0.96%
2/208 • Number of events 2
|
0.00%
0/200
|
|
Infections and infestations
Pharyngotonsillitis
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Infections and infestations
Pneumonia
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Infections and infestations
Rhinitis
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
1.0%
2/198 • Number of events 2
|
0.48%
1/208 • Number of events 1
|
1.0%
2/200 • Number of events 2
|
|
Infections and infestations
Skin infection
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Infections and infestations
Tonsillitis
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Infections and infestations
Tooth infection
|
1.0%
2/198 • Number of events 2
|
0.00%
0/208
|
0.00%
0/200
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/198
|
1.4%
3/208 • Number of events 3
|
0.00%
0/200
|
|
Infections and infestations
Urinary tract infection
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Fall
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Investigations
Blood calcium increased
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Investigations
Blood cholesterol increased
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Investigations
Blood creatine phosphokinase increased
|
1.0%
2/198 • Number of events 2
|
0.00%
0/208
|
0.00%
0/200
|
|
Investigations
Blood creatinine increased
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Investigations
Blood testosterone decreased
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Investigations
Blood urea increased
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Investigations
Blood uric acid increased
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Investigations
Heart rate decreased
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Investigations
Liver function test abnormal
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Investigations
Scan myocardial perfusion abnormal
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
2/198 • Number of events 2
|
0.48%
1/208 • Number of events 1
|
1.0%
2/200 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.51%
1/198 • Number of events 1
|
2.9%
6/208 • Number of events 6
|
1.5%
3/200 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.51%
1/198 • Number of events 2
|
0.00%
0/208
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/198
|
0.96%
2/208 • Number of events 2
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.51%
1/198 • Number of events 1
|
0.96%
2/208 • Number of events 2
|
1.0%
2/200 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.50%
1/200 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.0%
2/198 • Number of events 3
|
0.96%
2/208 • Number of events 2
|
1.0%
2/200 • Number of events 2
|
|
Nervous system disorders
Drooling
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Nervous system disorders
Headache
|
2.5%
5/198 • Number of events 5
|
5.8%
12/208 • Number of events 12
|
3.0%
6/200 • Number of events 6
|
|
Nervous system disorders
Lethargy
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Psychiatric disorders
Depression
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Psychiatric disorders
Libido decreased
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
0.51%
1/198 • Number of events 1
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Renal and urinary disorders
Terminal dribbling
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Reproductive system and breast disorders
Epididymitis
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Reproductive system and breast disorders
Penile pain
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Reproductive system and breast disorders
Prostatitis
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Reproductive system and breast disorders
Testicular pain
|
0.51%
1/198 • Number of events 2
|
0.00%
0/208
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/198
|
0.96%
2/208 • Number of events 2
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/198
|
0.48%
1/208 • Number of events 1
|
0.00%
0/200
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/198
|
0.00%
0/208
|
0.50%
1/200 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.51%
1/198 • Number of events 1
|
0.96%
2/208 • Number of events 2
|
0.50%
1/200 • Number of events 1
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
|
Surgical and medical procedures
Nasal septal operation
|
0.51%
1/198 • Number of events 1
|
0.00%
0/208
|
0.00%
0/200
|
Additional Information
Chief Medical Office
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60