Trial Outcomes & Findings for Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (NCT NCT00386009)
NCT ID: NCT00386009
Last Updated: 2009-07-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2009-07-09
Participant Flow
Participant milestones
| Measure |
Placebo
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
99
|
|
Overall Study
COMPLETED
|
92
|
89
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
Placebo
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Entry Criteria Not Met
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
Baseline Characteristics
Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
Placebo
n=101 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=99 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.03 years
STANDARD_DEVIATION 9.69 • n=5 Participants
|
58.16 years
STANDARD_DEVIATION 8.82 • n=7 Participants
|
58.60 years
STANDARD_DEVIATION 9.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=5 Participants
|
95 participants
n=7 Participants
|
194 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Baseline Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptom (LUTS) Severity
Moderate (IPSS <20)
|
34 participants
n=5 Participants
|
35 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Baseline Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptom (LUTS) Severity
Severe (IPSS ≥20)
|
66 participants
n=5 Participants
|
62 participants
n=7 Participants
|
128 participants
n=5 Participants
|
|
Baseline Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptom (LUTS) Severity
Missing Baseline Measure
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Bladder Outlet Obstruction Index (BOOI)
Obstructed (BOOI > 40)
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Bladder Outlet Obstruction Index (BOOI)
Equivocal (BOOI 20-40)
|
35 participants
n=5 Participants
|
34 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Bladder Outlet Obstruction Index (BOOI)
Unobstructed (BOOI < 20)
|
33 participants
n=5 Participants
|
31 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Duration of Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms (BPH LUTS)
6 months to 1 year
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Duration of Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms (BPH LUTS)
1 year to 3 years
|
36 participants
n=5 Participants
|
30 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Duration of Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms (BPH LUTS)
> 3 years
|
52 participants
n=5 Participants
|
57 participants
n=7 Participants
|
109 participants
n=5 Participants
|
|
Erectile Dysfunction Severity
Mild
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Erectile Dysfunction Severity
Moderate
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Erectile Dysfunction Severity
Severe
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Presence of Erectile Dysfunction
Yes
|
60 participants
n=5 Participants
|
58 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Presence of Erectile Dysfunction
No
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Previous Alpha-Blocker Therapy
Yes
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Previous Alpha-Blocker Therapy
No
|
79 participants
n=5 Participants
|
78 participants
n=7 Participants
|
157 participants
n=5 Participants
|
|
Previous Therapy for Benign Prostatic Hyperplasia
Yes
|
34 participants
n=5 Participants
|
29 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Previous Therapy for Benign Prostatic Hyperplasia
No
|
67 participants
n=5 Participants
|
70 participants
n=7 Participants
|
137 participants
n=5 Participants
|
|
Race/Ethnicity
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity
Asian
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity
Black or African American
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic or Latino
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Race/Ethnicity
White
|
78 participants
n=5 Participants
|
75 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
29.44 kilograms/square centimeters (kg/cm^2)
STANDARD_DEVIATION 4.47 • n=5 Participants
|
29.45 kilograms/square centimeters (kg/cm^2)
STANDARD_DEVIATION 4.93 • n=7 Participants
|
29.45 kilograms/square centimeters (kg/cm^2)
STANDARD_DEVIATION 4.69 • n=5 Participants
|
|
Body Weight
|
92.94 kilograms
STANDARD_DEVIATION 16.55 • n=5 Participants
|
93.90 kilograms
STANDARD_DEVIATION 16.49 • n=7 Participants
|
93.42 kilograms
STANDARD_DEVIATION 16.49 • n=5 Participants
|
|
Height
|
177.56 centimeters
STANDARD_DEVIATION 8.07 • n=5 Participants
|
178.58 centimeters
STANDARD_DEVIATION 7.50 • n=7 Participants
|
178.07 centimeters
STANDARD_DEVIATION 7.79 • n=5 Participants
|
|
Postvoid Residual Volume by Ultrasound
|
59.30 milliliters
STANDARD_DEVIATION 60.87 • n=5 Participants
|
45.65 milliliters
STANDARD_DEVIATION 49.58 • n=7 Participants
|
52.51 milliliters
STANDARD_DEVIATION 55.82 • n=5 Participants
|
|
Prostate Specific Antigen (PSA)
|
1.60 nanograms per milliliter
STANDARD_DEVIATION 1.13 • n=5 Participants
|
1.51 nanograms per milliliter
STANDARD_DEVIATION 1.14 • n=7 Participants
|
1.55 nanograms per milliliter
STANDARD_DEVIATION 1.13 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
Outcome measures
| Measure |
Placebo
n=91 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=84 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)
Baseline
|
54.83 centimeters of water (cm H20)
Standard Deviation 27.36
|
56.87 centimeters of water (cm H20)
Standard Deviation 29.67
|
|
Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)
Change from Baseline to 12 Week Endpoint
|
1.92 centimeters of water (cm H20)
Standard Deviation 19.71
|
-2.95 centimeters of water (cm H20)
Standard Deviation 15.92
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
Qmax was measured during free-flow tests using a standard calibrated flow meter.
Outcome measures
| Measure |
Placebo
n=89 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=82 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies
Baseline
|
13.03 milliliters per second
Standard Deviation 7.34
|
14.75 milliliters per second
Standard Deviation 10.70
|
|
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies
Change from Baseline to 12 Week Endpoint
|
0.52 milliliters per second
Standard Deviation 7.83
|
0.01 milliliters per second
Standard Deviation 8.83
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
Qave was measured during free-flow tests using a standard calibrated flow meter.
Outcome measures
| Measure |
Placebo
n=70 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=59 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies
Baseline
|
7.10 millilters per second
Standard Deviation 4.37
|
7.23 millilters per second
Standard Deviation 4.18
|
|
Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies
Change from Baseline to 12 Week Endpoint
|
-0.01 millilters per second
Standard Deviation 4.11
|
1.00 millilters per second
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
Outcome measures
| Measure |
Placebo
n=88 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=82 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies
Baseline
|
258.56 milliliters
Standard Deviation 134.21
|
268.22 milliliters
Standard Deviation 149.77
|
|
Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies
Change from Baseline to 12 Week Endpoint
|
-4.10 milliliters
Standard Deviation 151.82
|
-5.17 milliliters
Standard Deviation 151.73
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization.
Outcome measures
| Measure |
Placebo
n=78 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=79 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies
Baseline
|
59.62 milliliters
Standard Deviation 66.74
|
48.99 milliliters
Standard Deviation 65.73
|
|
Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies
Change from Baseline to 12 Week Endpoint
|
-1.85 milliliters
Standard Deviation 80.92
|
-9.13 milliliters
Standard Deviation 70.36
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full).
Outcome measures
| Measure |
Placebo
n=77 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=78 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies
Baseline
|
327.95 milliliters
Standard Deviation 165.66
|
316.79 milliliters
Standard Deviation 187.31
|
|
Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies
Change from Baseline to 12 Week Endpoint
|
-17.53 milliliters
Standard Deviation 182.62
|
-14.88 milliliters
Standard Deviation 187.10
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full).
Outcome measures
| Measure |
Placebo
n=77 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=78 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies
Baseline
|
84.01 milliliters
Standard Deviation 14.56
|
85.85 milliliters
Standard Deviation 13.44
|
|
Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies
Change from Baseline to 12 Week Endpoint
|
-0.52 milliliters
Standard Deviation 16.31
|
1.85 milliliters
Standard Deviation 16.22
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
Qmax was measured duirng pressure-flow tests.
Outcome measures
| Measure |
Placebo
n=91 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=84 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies
Baseline
|
9.49 milliliters per second
Standard Deviation 4.90
|
10.29 milliliters per second
Standard Deviation 4.46
|
|
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies
Change from Baseline to 12 Week Endpoint
|
0.50 milliliters per second
Standard Deviation 2.91
|
0.38 milliliters per second
Standard Deviation 2.92
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
Qave was measured during pressure-flow tests.
Outcome measures
| Measure |
Placebo
n=87 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=81 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies
Baseline
|
4.67 milliliters per second
Standard Deviation 2.44
|
5.50 milliliters per second
Standard Deviation 2.68
|
|
Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies
Change from Baseline to 12 Week Endpoint
|
0.45 milliliters per second
Standard Deviation 1.66
|
0.58 milliliters per second
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
Vcomp was defined as the volume of voided urine measured during pressure-flow tests.
Outcome measures
| Measure |
Placebo
n=91 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=84 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies
Baseline
|
294.10 milliliters
Standard Deviation 147.74
|
296.64 milliliters
Standard Deviation 143.30
|
|
Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies
Change from Baseline to 12 Week Endpoint
|
3.31 milliliters
Standard Deviation 140.46
|
13.51 milliliters
Standard Deviation 99.64
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
Max Pdet was defined as the maximum detrusor pressure observed during voiding.
Outcome measures
| Measure |
Placebo
n=83 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=78 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies
Baseline
|
67.13 centimeters of water (cm H20)
Standard Deviation 31.66
|
72.20 centimeters of water (cm H20)
Standard Deviation 38.65
|
|
Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies
Change from Baseline to 12 Week Endpoint
|
-0.48 centimeters of water (cm H20)
Standard Deviation 28.19
|
-2.11 centimeters of water (cm H20)
Standard Deviation 24.08
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
BCI was derived from the equation PdetQmax + 5Qmax. Scores: \<100 means weak, 100-150 menas normal, \>150 means strong. A decrease means a decrease in contractility of the bladder.
Outcome measures
| Measure |
Placebo
n=91 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=84 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies
Baseline
|
102.28 units on a nomogram
Standard Deviation 32.84
|
108.32 units on a nomogram
Standard Deviation 32.14
|
|
Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies
Change from Baseline to 12 Week Endpoint
|
4.43 units on a nomogram
Standard Deviation 20.86
|
-1.04 units on a nomogram
Standard Deviation 20.37
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: \<20 means unobstructed, 20-40 means equivocol, \>40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement).
Outcome measures
| Measure |
Placebo
n=91 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=84 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies
Baseline
|
35.84 units on a nomogram
Standard Deviation 30.87
|
36.28 units on a nomogram
Standard Deviation 33.14
|
|
Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies
Change from Baseline to 12 Week Endpoint
|
0.92 units on a nomogram
Standard Deviation 22.10
|
-3.71 units on a nomogram
Standard Deviation 17.56
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
Outcome measures
| Measure |
Placebo
n=91 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=84 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Presence of Involuntary Detrusor Contractions During Bladder Filling
Present at Baseline
|
33 participants
|
28 participants
|
|
Presence of Involuntary Detrusor Contractions During Bladder Filling
Not Present at Baseline
|
58 participants
|
56 participants
|
|
Presence of Involuntary Detrusor Contractions During Bladder Filling
Present at Endpoint
|
36 participants
|
31 participants
|
|
Presence of Involuntary Detrusor Contractions During Bladder Filling
Not Present at Endpoint
|
55 participants
|
53 participants
|
|
Presence of Involuntary Detrusor Contractions During Bladder Filling
Present at Both Baseline and Endpoint
|
22 participants
|
18 participants
|
|
Presence of Involuntary Detrusor Contractions During Bladder Filling
Present at Baseline Only
|
11 participants
|
10 participants
|
|
Presence of Involuntary Detrusor Contractions During Bladder Filling
Present at Endpoint Only
|
14 participants
|
13 participants
|
|
Presence of Involuntary Detrusor Contractions During Bladder Filling
Present at Neither Baseline nor Endpoint
|
44 participants
|
43 participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of participants in the Primary Analysis Population with involuntary detrusor contractions during bladder filling at both baseline and endpoint.
Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint.
Outcome measures
| Measure |
Placebo
n=22 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=18 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction
Baseline
|
120.55 milliliters
Standard Deviation 82.50
|
164.00 milliliters
Standard Deviation 108.31
|
|
Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction
Change from Baseline to 12 Week Endpoint
|
27.86 milliliters
Standard Deviation 128.20
|
28.56 milliliters
Standard Deviation 106.67
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
The IPSS Total Score is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Outcome measures
| Measure |
Placebo
n=91 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=82 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
Baseline
|
22.01 units on a scale
Standard Deviation 5.72
|
21.46 units on a scale
Standard Deviation 5.63
|
|
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
Change from Baseline to 12 Week Endpoint
|
-5.04 units on a scale
Standard Deviation 6.93
|
-9.13 units on a scale
Standard Deviation 6.90
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All randomized participants.
Laboratory tests that were statistically significant and clinically adverse would be reported for safety.
Outcome measures
| Measure |
Placebo
n=98 Participants
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=94 Participants
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests
|
0 significant and clinically adverse labs
0.41
|
0 significant and clinically adverse labs
0.33
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Tadalafil
Serious events: 3 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction/Death
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Infections and infestations
Cellulitis
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
Other adverse events
| Measure |
Placebo
placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
20 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Cardiac disorders
Syncope
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Eye disorders
Visual disturbance
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.99%
1/101 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/101
|
8.1%
8/99 • Number of events 8
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/101
|
2.0%
2/99 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/101
|
3.0%
3/99 • Number of events 3
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.99%
1/101 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.99%
1/101 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Ear infection
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Gastroenteritis aeromonas
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Infections and infestations
Influenza
|
0.99%
1/101 • Number of events 1
|
2.0%
2/99 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
2/101 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
2/101 • Number of events 2
|
2.0%
2/99 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Investigations
Biopsy prostate
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Investigations
Blood creatinine increased
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/101
|
2.0%
2/99 • Number of events 2
|
|
Investigations
Liver function test abnormal
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Investigations
Prostatic specific antigen increased
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Metabolism and nutrition disorders
Diabetes mellitus non-insulin-dependent
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
2/101 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/101
|
2.0%
2/99 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
3/101 • Number of events 3
|
5.1%
5/99 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
2/101 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/101
|
2.0%
2/99 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Nervous system disorders
Amnesia
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Nervous system disorders
Dizziness
|
3.0%
3/101 • Number of events 3
|
0.00%
0/99
|
|
Nervous system disorders
Headache
|
3.0%
3/101 • Number of events 3
|
7.1%
7/99 • Number of events 7
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Nervous system disorders
Sciatica
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Psychiatric disorders
Nicotine dependence
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.99%
1/101 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Reproductive system and breast disorders
Penis disorder
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
2/101 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.99%
1/101 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/101
|
2.0%
2/99 • Number of events 2
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Surgical and medical procedures
Endodontic procedure
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Surgical and medical procedures
Foot operation
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Surgical and medical procedures
Tooth repair
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.00%
0/101
|
1.0%
1/99 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60