Trial Outcomes & Findings for Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily (NCT NCT00827242)
NCT ID: NCT00827242
Last Updated: 2010-11-17
Results Overview
The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 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, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.
COMPLETED
PHASE3
325 participants
Baseline, 12 weeks
2010-11-17
Participant Flow
Participant milestones
| Measure |
Tadalafil
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Overall Study
STARTED
|
161
|
164
|
|
Overall Study
COMPLETED
|
148
|
152
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
| Measure |
Tadalafil
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Adverse Event Excluding Death
|
2
|
1
|
|
Overall Study
Entry Criteria Not Met
|
4
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily
Baseline characteristics by cohort
| Measure |
Tadalafil
n=161 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=164 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
Total
n=325 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
65.1 years
STANDARD_DEVIATION 8.43 • n=99 Participants
|
64.6 years
STANDARD_DEVIATION 10.03 • n=107 Participants
|
64.9 years
STANDARD_DEVIATION 9.26 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=99 Participants
|
164 Participants
n=107 Participants
|
325 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
115 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
235 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
146 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
296 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
52 participants
n=107 Participants
|
102 participants
n=206 Participants
|
|
Region of Enrollment
South America
|
43 participants
n=99 Participants
|
43 participants
n=107 Participants
|
86 participants
n=206 Participants
|
|
Region of Enrollment
Europe
|
68 participants
n=99 Participants
|
69 participants
n=107 Participants
|
137 participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
27.1 kilogram (kg)/meter (m)^2
STANDARD_DEVIATION 3.82 • n=99 Participants
|
28.4 kilogram (kg)/meter (m)^2
STANDARD_DEVIATION 4.21 • n=107 Participants
|
27.7 kilogram (kg)/meter (m)^2
STANDARD_DEVIATION 4.07 • n=206 Participants
|
|
Baseline Lower Urinary Tract Symptoms (LUTS) Severity
Moderate
|
100 participants
n=99 Participants
|
110 participants
n=107 Participants
|
210 participants
n=206 Participants
|
|
Baseline Lower Urinary Tract Symptoms (LUTS) Severity
Severe
|
61 participants
n=99 Participants
|
54 participants
n=107 Participants
|
115 participants
n=206 Participants
|
|
Peak Urine Flow Rate (Qmax) Category
<10 mL/sec
|
54 participants
n=99 Participants
|
62 participants
n=107 Participants
|
116 participants
n=206 Participants
|
|
Peak Urine Flow Rate (Qmax) Category
10-15 mL/sec
|
78 participants
n=99 Participants
|
67 participants
n=107 Participants
|
145 participants
n=206 Participants
|
|
Peak Urine Flow Rate (Qmax) Category
>15 mL/sec
|
20 participants
n=99 Participants
|
24 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Post-void Residual Volume (PVR)
|
44.9 mL
STANDARD_DEVIATION 44.87 • n=99 Participants
|
63.3 mL
STANDARD_DEVIATION 59.88 • n=107 Participants
|
54.2 mL
STANDARD_DEVIATION 53.70 • n=206 Participants
|
|
Prostate-Specific Antigen (PSA)
|
2.0 ng/mL
STANDARD_DEVIATION 1.75 • n=99 Participants
|
2.2 ng/mL
STANDARD_DEVIATION 1.72 • n=107 Participants
|
2.1 ng/mL
STANDARD_DEVIATION 1.74 • n=206 Participants
|
|
Erectile Dysfunction (ED)
Yes
|
112 participants
n=99 Participants
|
112 participants
n=107 Participants
|
224 participants
n=206 Participants
|
|
Erectile Dysfunction (ED)
No
|
49 participants
n=99 Participants
|
52 participants
n=107 Participants
|
101 participants
n=206 Participants
|
|
ED Severity
Mild
|
34 participants
n=99 Participants
|
40 participants
n=107 Participants
|
74 participants
n=206 Participants
|
|
ED Severity
Moderate
|
61 participants
n=99 Participants
|
59 participants
n=107 Participants
|
120 participants
n=206 Participants
|
|
ED Severity
Severe
|
17 participants
n=99 Participants
|
13 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
ED Duration
<1 year
|
14 participants
n=99 Participants
|
17 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
ED Duration
>=1 year
|
98 participants
n=99 Participants
|
95 participants
n=107 Participants
|
193 participants
n=206 Participants
|
|
Sexually Active with a Female Partner
Yes
|
128 participants
n=99 Participants
|
129 participants
n=107 Participants
|
257 participants
n=206 Participants
|
|
Sexually Active with a Female Partner
No
|
33 participants
n=99 Participants
|
35 participants
n=107 Participants
|
68 participants
n=206 Participants
|
|
Expect to Remain Sexually Active
Yes
|
127 participants
n=99 Participants
|
129 participants
n=107 Participants
|
256 participants
n=206 Participants
|
|
Expect to Remain Sexually Active
No
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Patient Global Impression of Severity (PGI-S)
Normal
|
5 participants
n=99 Participants
|
8 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Patient Global Impression of Severity (PGI-S)
Mild
|
35 participants
n=99 Participants
|
27 participants
n=107 Participants
|
62 participants
n=206 Participants
|
|
Patient Global Impression of Severity (PGI-S)
Moderate
|
102 participants
n=99 Participants
|
105 participants
n=107 Participants
|
207 participants
n=206 Participants
|
|
Patient Global Impression of Severity (PGI-S)
Severe
|
19 participants
n=99 Participants
|
24 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Clinician Global Impression of Severity (CGI-S)
Normal
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Clinician Global Impression of Severity (CGI-S)
Mild
|
36 participants
n=99 Participants
|
37 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
Clinician Global Impression of Severity (CGI-S)
Moderate
|
104 participants
n=99 Participants
|
95 participants
n=107 Participants
|
199 participants
n=206 Participants
|
|
Clinician Global Impression of Severity (CGI-S)
Severe
|
21 participants
n=99 Participants
|
31 participants
n=107 Participants
|
52 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population was defined as all subjects who were randomized, started study medication, and had non-missing data at baseline and at least one post-baseline visit. The Last Observation Carried Forward (LOCF) imputation technique was employed.
The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 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, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil
n=160 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=164 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS)
|
-5.6 Units on a Scale
Standard Error 0.47
|
-3.6 Units on a Scale
Standard Error 0.47
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4.
The BPH Impact Index (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. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil
n=158 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=162 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index
|
-1.8 Units on a Scale
Standard Error 0.18
|
-1.2 Units on a Scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 12. For the 12 week analysis, the LOCF imputation technique was used.
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. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil
n=160 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=163 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index
|
-1.8 Units on a Scale
Standard Error 0.21
|
-1.3 Units on a Scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.
IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil
n=160 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=164 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore
|
-2.3 Units on a Scale
Standard Error 0.22
|
-1.3 Units on a Scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil
n=160 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=164 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore
|
-3.3 Units on a Scale
Standard Error 0.31
|
-2.3 Units on a Scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.
Measures nocturia (the need to get up at night to urinate). Scores range from 0 (few episodes of nocturia) to 5 (frequent episodes of nocturia). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil
n=160 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=164 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Nocturia Question
|
-0.5 Units on a Scale
Standard Error 0.08
|
-0.4 Units on a Scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.
Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil
n=160 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=164 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index
|
-1.0 Units on a Scale
Standard Error 0.10
|
-0.7 Units on a Scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The analysis population includes all subjects who were randomized, started study medication, and had non-missing data.
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Tadalafil
n=155 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=158 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories
7-Very Much Worse
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories
6-Much Worse
|
5 Participants
|
6 Participants
|
|
Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories
5-A Little Worse
|
4 Participants
|
4 Participants
|
|
Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories
4-No Change
|
30 Participants
|
57 Participants
|
|
Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories
3-A Little Better
|
57 Participants
|
53 Participants
|
|
Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories
2-Much Better
|
46 Participants
|
32 Participants
|
|
Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories
1-Very Much Better
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All values are based on the number of subjects in the analysis population with non-missing data.
Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Tadalafil
n=155 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=158 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories
4-No Change
|
36 Participants
|
59 Participants
|
|
Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories
7-Very Much Worse
|
0 Participants
|
0 Participants
|
|
Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories
6-Much Worse
|
5 Participants
|
2 Participants
|
|
Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories
5-A Little Worse
|
4 Participants
|
10 Participants
|
|
Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories
3-A Little Better
|
58 Participants
|
55 Participants
|
|
Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories
2-Much Better
|
39 Participants
|
25 Participants
|
|
Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories
1-Very Much Better
|
13 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 weekPopulation: The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 1.
The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 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. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil
n=147 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=150 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 1 Week, International Prostate Symptom Score (IPSS)
|
-3.4 Units on a Scale
Standard Error 0.35
|
-2.7 Units on a Scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline, 4 WeeksPopulation: The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4.
The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 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. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil
n=158 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=162 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 4 Weeks, International Prostate Symptom Score (IPSS)
|
-5.3 Units on a Scale
Standard Error 0.43
|
-3.5 Units on a Scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. Measures were taken only for those subjects who reported they were sexually active and reported erectile dysfunction. The LOCF imputation technique was employed.
Self-reported EF. Scores range from 0 (low or no EF) to 5 (high EF) on 6 questions (1-5, 15 of the IIEF). EF Domain scores range from 0 to 30. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.
Outcome measures
| Measure |
Tadalafil
n=88 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=84 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 12 Weeks, International Index of Erectile Function (IIEF)- Erectile Function (EF) Domain Scores
|
6.7 Units on a Scale
Standard Error 0.80
|
2.0 Units on a Scale
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).
Qmax was 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
n=127 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=135 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 12 Weeks, Peak Flow Rate (Qmax) by Uroflowmetry
|
1.6 mL/sec
Standard Deviation 4.64
|
1.1 mL/sec
Standard Deviation 4.64
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).
Qmean was defined as the mean urine flow rate (measured in 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 mL and the Vcomp was \>=125 mL.
Outcome measures
| Measure |
Tadalafil
n=127 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=135 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 12 Weeks, Mean Flow Rate (Qmean) by Uroflowmetry
|
0.6 mL/sec
Standard Deviation 2.93
|
0.5 mL/sec
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).
Vcomp was defined as the volume of urine voided (measured in mL 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 mL and the Vcomp was \>=125 mL.
Outcome measures
| Measure |
Tadalafil
n=127 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=135 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 12 Weeks, Voided Volume (Vcomp) by Uroflowmetry
|
16.9 mL
Standard Deviation 88.74
|
3.9 mL
Standard Deviation 105.68
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).
The amount of urine remaining in the bladder after void completion.
Outcome measures
| Measure |
Tadalafil
n=154 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=158 Participants
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Change From Baseline to 12 Weeks, Postvoid Residual (PVR) Volume
|
8.8 mL
Standard Deviation 56.40
|
4.5 mL
Standard Deviation 66.71
|
Adverse Events
Tadalafil
Placebo
Serious adverse events
| Measure |
Tadalafil
n=161 participants at risk
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=164 participants at risk
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Infections and infestations
Endocarditis
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
Other adverse events
| Measure |
Tadalafil
n=161 participants at risk
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
|
Placebo
n=164 participants at risk
Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
|
|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Ear and labyrinth disorders
Ear pain
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Endocrine disorders
Hypothyroidism
|
0.62%
1/161 • Number of events 1
|
0.61%
1/164 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.62%
1/161 • Number of events 1
|
0.61%
1/164 • Number of events 1
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.62%
1/161 • Number of events 1
|
1.2%
2/164 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.62%
1/161 • Number of events 1
|
0.61%
1/164 • Number of events 1
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.2%
2/161 • Number of events 2
|
0.00%
0/164
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.62%
1/161 • Number of events 1
|
0.61%
1/164 • Number of events 1
|
|
General disorders
Asthenia
|
0.62%
1/161 • Number of events 2
|
0.61%
1/164 • Number of events 2
|
|
General disorders
Influenza like illness
|
0.62%
1/161 • Number of events 1
|
0.61%
1/164 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Hepatobiliary disorders
Biliary colic
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Infections and infestations
Bronchitis
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Infections and infestations
Gastroenteritis
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Infections and infestations
Influenza
|
0.62%
1/161 • Number of events 1
|
1.8%
3/164 • Number of events 4
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
3/161 • Number of events 3
|
1.8%
3/164 • Number of events 4
|
|
Infections and infestations
Sinusitis
|
1.2%
2/161 • Number of events 2
|
0.00%
0/164
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Vertebral injury
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Investigations
Endoscopy
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Investigations
Hepatic enzyme increased
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Investigations
Prostatic specific antigen increased
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
3/161 • Number of events 3
|
0.00%
0/164
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
5/161 • Number of events 5
|
2.4%
4/164 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
2/161 • Number of events 2
|
0.00%
0/164
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
2/161 • Number of events 2
|
0.00%
0/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.62%
1/161 • Number of events 1
|
0.61%
1/164 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.9%
3/161 • Number of events 3
|
0.00%
0/164
|
|
Nervous system disorders
Headache
|
3.7%
6/161 • Number of events 6
|
0.61%
1/164 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Psychiatric disorders
Insomnia
|
1.2%
2/161 • Number of events 2
|
0.00%
0/164
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Renal and urinary disorders
Nocturia
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/161
|
1.2%
2/164 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/161
|
1.2%
2/164 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.62%
1/161 • Number of events 1
|
0.00%
0/164
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/161
|
0.61%
1/164 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.9%
3/161 • Number of events 3
|
1.8%
3/164 • Number of events 3
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60