Trial Outcomes & Findings for A Study in Benign Prostatic Hyperplasia (NCT NCT01152190)
NCT ID: NCT01152190
Last Updated: 2013-05-20
Results Overview
Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to blood flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.
COMPLETED
PHASE3
97 participants
Baseline, Week 8
2013-05-20
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: tablet administered orally, once daily for 8 weeks.
|
Tadalafil
Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
47
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
50
|
47
|
|
Overall Study
COMPLETED
|
45
|
39
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: tablet administered orally, once daily for 8 weeks.
|
Tadalafil
Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
A Study in Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
Placebo
n=50 Participants
Placebo: tablet administered orally, once daily for 8 weeks.
|
Tadalafil
n=47 Participants
Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.3 years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 7.53 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 7.83 • 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
|
50 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
21 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Erectile Dysfunction (ED) Etiology
Psychogenic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Erectile Dysfunction (ED) Etiology
Organic
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Erectile Dysfunction (ED) Etiology
Mixed
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Erectile Dysfunction (ED) Etiology
Unknown
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
ED Severity
Mild
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
ED Severity
Moderate
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
ED Severity
Severe
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
ED Duration
<1 year
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
ED Duration
≥1 year
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Body Mass Index
|
27.4 kilograms per meter-squared (kg/m^2)
STANDARD_DEVIATION 3.19 • n=5 Participants
|
26.4 kilograms per meter-squared (kg/m^2)
STANDARD_DEVIATION 3.28 • n=7 Participants
|
26.9 kilograms per meter-squared (kg/m^2)
STANDARD_DEVIATION 3.25 • n=5 Participants
|
|
Sitting Diastolic Blood Pressure
|
81.8 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 8.73 • n=5 Participants
|
81.5 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 6.85 • n=7 Participants
|
81.7 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 7.83 • n=5 Participants
|
|
Sitting Systolic Blood Pressure
|
131.0 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 13.69 • n=5 Participants
|
131.7 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 11.96 • n=7 Participants
|
131.4 millimeters of mercury (mm Hg)
STANDARD_DEVIATION 12.82 • n=5 Participants
|
|
Baseline Lower Urinary Tract Symptoms (LUTS) Severity
Moderate
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Baseline Lower Urinary Tract Symptoms (LUTS) Severity
Severe
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Urinary Peak Flow Rate (Qmax)
|
9.6 milliliters per second (mL/sec)
STANDARD_DEVIATION 2.50 • n=5 Participants
|
10.4 milliliters per second (mL/sec)
STANDARD_DEVIATION 2.78 • n=7 Participants
|
10.0 milliliters per second (mL/sec)
STANDARD_DEVIATION 2.65 • n=5 Participants
|
|
Postvoid Residual Volume
|
59.0 milliliters (mL)
STANDARD_DEVIATION 59.11 • n=5 Participants
|
47.8 milliliters (mL)
STANDARD_DEVIATION 44.47 • n=7 Participants
|
53.6 milliliters (mL)
STANDARD_DEVIATION 52.56 • n=5 Participants
|
|
Prostate Specific Antigen
|
1.9 nanograms per milliliter (ng/mL)
STANDARD_DEVIATION 1.70 • n=5 Participants
|
2.1 nanograms per milliliter (ng/mL)
STANDARD_DEVIATION 1.93 • n=7 Participants
|
2.0 nanograms per milliliter (ng/mL)
STANDARD_DEVIATION 1.81 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit.
Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to blood flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo: tablet administered orally, once daily for 8 weeks.
|
Tadalafil
n=38 Participants
Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone
|
-0.01 ratio
Standard Error 0.006
|
0.00 ratio
Standard Error 0.006
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit.
Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo: tablet administered orally, once daily for 8 weeks.
|
Tadalafil
n=43 Participants
Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone
|
0.00 ratio
Standard Error 0.006
|
0.01 ratio
Standard Error 0.006
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 8Population: Randomized participants who received at least 1 dose of study medication.
Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo: tablet administered orally, once daily for 8 weeks.
|
Tadalafil
n=43 Participants
Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck
Week 4 Change, Bladder Neck (n=30, 30)
|
-0.01 ratio
Standard Error 0.012
|
0.01 ratio
Standard Error 0.012
|
|
Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck
Week 4 Change, Prostate Peripheral Zone (n=45, 43)
|
0.00 ratio
Standard Error 0.006
|
0.01 ratio
Standard Error 0.007
|
|
Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck
Week 8 Change, Prostate Peripheral Zone (n=43, 38)
|
-0.01 ratio
Standard Error 0.006
|
0.01 ratio
Standard Error 0.007
|
|
Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck
Week 8 Change, Bladder Neck (n=32, 26)
|
0.01 ratio
Standard Error 0.015
|
0.02 ratio
Standard Error 0.016
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 8Population: Randomized participants who received at least 1 dose of study medication.
CPI quantified blood flow in a pre-specified region of interest by using color Doppler imaging. CPI was the mean color pixel intensity in the region of interest and scores could range from 0 to 160. An increase in CPI reflected an increase in blood flow. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.
Outcome measures
| Measure |
Placebo
n=44 Participants
Placebo: tablet administered orally, once daily for 8 weeks.
|
Tadalafil
n=43 Participants
Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck
Week 4 Change, Prostate Transition Zone (n=44, 43)
|
-2.21 units on a scale
Standard Error 2.377
|
0.42 units on a scale
Standard Error 2.408
|
|
Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck
Week 8 Change, Prostate Transition Zone (n=43, 38)
|
2.02 units on a scale
Standard Error 1.974
|
2.53 units on a scale
Standard Error 2.083
|
|
Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck
Week 4 Change, Prostate Peripheral Zone (n=44, 43)
|
-1.48 units on a scale
Standard Error 2.059
|
1.99 units on a scale
Standard Error 2.091
|
|
Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck
Week 8 Change, Prostate Peripheral Zone (n=43, 38)
|
3.11 units on a scale
Standard Error 1.868
|
2.55 units on a scale
Standard Error 1.987
|
|
Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck
Week 4 Change, Bladder Neck (n=42, 40)
|
7.37 units on a scale
Standard Error 4.022
|
3.17 units on a scale
Standard Error 4.140
|
|
Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck
Week 8 Change, Bladder Neck (n=38, 36)
|
-0.13 units on a scale
Standard Error 3.622
|
7.81 units on a scale
Standard Error 3.738
|
Adverse Events
Placebo
Tadalafil
Serious adverse events
| Measure |
Placebo
n=50 participants at risk
Placebo: tablet administered orally, once daily for 8 weeks.
|
Tadalafil
n=47 participants at risk
Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
2.0%
1/50 • Number of events 1
|
0.00%
0/47
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/50 • Number of events 1
|
0.00%
0/47
|
|
Nervous system disorders
Carotid artery stenosis
|
2.0%
1/50 • Number of events 1
|
0.00%
0/47
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
2.0%
1/50 • Number of events 1
|
0.00%
0/47
|
Other adverse events
| Measure |
Placebo
n=50 participants at risk
Placebo: tablet administered orally, once daily for 8 weeks.
|
Tadalafil
n=47 participants at risk
Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/50
|
2.1%
1/47 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/50
|
2.1%
1/47 • Number of events 1
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/50
|
2.1%
1/47 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/50 • Number of events 1
|
0.00%
0/47
|
|
Infections and infestations
Bronchitis
|
0.00%
0/50
|
2.1%
1/47 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/50
|
2.1%
1/47 • Number of events 1
|
|
Infections and infestations
Subcutaneous abscess
|
2.0%
1/50 • Number of events 1
|
0.00%
0/47
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/50
|
2.1%
1/47 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/50
|
2.1%
1/47 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.0%
1/50 • Number of events 1
|
0.00%
0/47
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/50
|
2.1%
1/47 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Number of events 1
|
8.5%
4/47 • Number of events 4
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
1/50 • Number of events 1
|
0.00%
0/47
|
|
Psychiatric disorders
Depression
|
2.0%
1/50 • Number of events 1
|
0.00%
0/47
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/50
|
2.1%
1/47 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/50
|
2.1%
1/47 • Number of events 1
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/50
|
2.1%
1/47 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/50 • Number of events 1
|
0.00%
0/47
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.0%
1/50 • Number of events 1
|
0.00%
0/47
|
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