Trial Outcomes & Findings for Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men (NCT NCT00540124)

Last Updated: 2010-11-25

Results Overview

The IPSS Total Score is obtained by combining the scores of the responses to 1 through 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

151 participants

Primary outcome timeframe

baseline, 12 weeks

Results posted on

2010-11-25

Participant Flow

There were three periods to this study. Period 1 was a 4-week Screening/Washout Period. 196 subjects screened (45 failures). Period 2 was a 4-week Placebo Run-in Period. Period 3 was a 12-week Treatment Period (151 subjects randomized).

Participant milestones

Participant milestones
Measure	Placebo by mouth once a day	Tadalafil 5 mg by mouth once a day	Tamsulosin 0.2 mg by mouth once a day
Overall Study STARTED	51	51	49
Overall Study COMPLETED	47	48	48
Overall Study NOT COMPLETED	4	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo by mouth once a day	Tadalafil 5 mg by mouth once a day	Tamsulosin 0.2 mg by mouth once a day
Overall Study Adverse Event	0	2	1
Overall Study Entry Criteria Not Met	2	0	0
Overall Study Lack of Efficacy	1	0	0
Overall Study Withdrawal by Subject	1	1	0

Baseline Characteristics

Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=51 Participants by mouth once a day	Tadalafil n=51 Participants 5 mg by mouth once a day	Tamsulosin n=49 Participants 0.2 mg by mouth once a day	Total n=151 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Korea, Republic of	51 participants n=5 Participants	51 participants n=7 Participants	49 participants n=5 Participants	151 participants n=4 Participants
Erectile Dysfunction (ED) Yes	36 participants n=5 Participants	30 participants n=7 Participants	24 participants n=5 Participants	90 participants n=4 Participants
Erectile Dysfunction (ED) No	15 participants n=5 Participants	21 participants n=7 Participants	25 participants n=5 Participants	61 participants n=4 Participants
Duration of Erectile Dysfunction (ED) <3 Months	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Duration of Erectile Dysfunction (ED) 3 Months to < 6 Months	2 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	6 participants n=4 Participants
Duration of Erectile Dysfunction (ED) 6 Months to < 1 Year	5 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	13 participants n=4 Participants
Age Continuous	62.2 years STANDARD_DEVIATION 6.8 • n=5 Participants	61.2 years STANDARD_DEVIATION 6.6 • n=7 Participants	61.5 years STANDARD_DEVIATION 6.4 • n=5 Participants	61.6 years STANDARD_DEVIATION 6.6 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	51 Participants n=7 Participants	49 Participants n=5 Participants	151 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	51 Participants n=5 Participants	51 Participants n=7 Participants	49 Participants n=5 Participants	151 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Duration of Erectile Dysfunction (ED) 1 Year or More	29 participants n=5 Participants	23 participants n=7 Participants	18 participants n=5 Participants	70 participants n=4 Participants
Etiology of Erectile Dysfunction (ED) Psychogenic	2 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Etiology of Erectile Dysfunction (ED) Organic	16 participants n=5 Participants	10 participants n=7 Participants	11 participants n=5 Participants	37 participants n=4 Participants
Etiology of Erectile Dysfunction (ED) Mixed	17 participants n=5 Participants	15 participants n=7 Participants	12 participants n=5 Participants	44 participants n=4 Participants
Etiology of Erectile Dysfunction (ED) Unknown	1 participants n=5 Participants	5 participants n=7 Participants	1 participants n=5 Participants	7 participants n=4 Participants
Severity of Erectile Dysfunction (ED) Mild	17 participants n=5 Participants	22 participants n=7 Participants	13 participants n=5 Participants	52 participants n=4 Participants
Severity of Erectile Dysfunction (ED) Moderate	14 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants	26 participants n=4 Participants
Severity of Erectile Dysfunction (ED) Severe	5 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	12 participants n=4 Participants
Lower Urinary Tract Symptoms Severity Moderate (IPSS < 20)	35 participants n=5 Participants	35 participants n=7 Participants	33 participants n=5 Participants	103 participants n=4 Participants
Lower Urinary Tract Symptoms Severity Severe (IPSS ≥20)	16 participants n=5 Participants	16 participants n=7 Participants	16 participants n=5 Participants	48 participants n=4 Participants
Postvoid Residual Volume (PRV)	34.4 milliliters STANDARD_DEVIATION 35.7 • n=5 Participants	30.9 milliliters STANDARD_DEVIATION 33.8 • n=7 Participants	42.0 milliliters STANDARD_DEVIATION 59.6 • n=5 Participants	35.7 milliliters STANDARD_DEVIATION 44.3 • n=4 Participants
Height	168.6 centimeters STANDARD_DEVIATION 5.2 • n=5 Participants	168.6 centimeters STANDARD_DEVIATION 5.5 • n=7 Participants	167.3 centimeters STANDARD_DEVIATION 4.6 • n=5 Participants	168.2 centimeters STANDARD_DEVIATION 5.1 • n=4 Participants
Weight	70.7 kilograms STANDARD_DEVIATION 8.1 • n=5 Participants	70.1 kilograms STANDARD_DEVIATION 7.5 • n=7 Participants	68.4 kilograms STANDARD_DEVIATION 7.6 • n=5 Participants	69.7 kilograms STANDARD_DEVIATION 7.7 • n=4 Participants
Body Mass Index	24.8 kilograms/meters squared (kg/m^2) STANDARD_DEVIATION 2.2 • n=5 Participants	24.7 kilograms/meters squared (kg/m^2) STANDARD_DEVIATION 2.3 • n=7 Participants	24.4 kilograms/meters squared (kg/m^2) STANDARD_DEVIATION 2.1 • n=5 Participants	24.6 kilograms/meters squared (kg/m^2) STANDARD_DEVIATION 2.2 • n=4 Participants

PRIMARY outcome

Timeframe: baseline, 12 weeks

Population: Primary analysis was performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants by mouth once a day	Tadalafil n=50 Participants 5 mg by mouth once a day	Tamsulosin n=49 Participants 0.2 mg by mouth once a day
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score Baseline	17.3 units on a scale Standard Deviation 5.0	17.1 units on a scale Standard Deviation 5.4	17.7 units on a scale Standard Deviation 5.0
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score 12 Week Change	-4.2 units on a scale Standard Deviation 4.8	-5.8 units on a scale Standard Deviation 4.6	-5.6 units on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: baseline, 4 and 8 weeks

Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants by mouth once a day	Tadalafil n=50 Participants 5 mg by mouth once a day	Tamsulosin n=49 Participants 0.2 mg by mouth once a day
Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score 4 Week Change (n=50, n=49, n=49)	-2.8 units on a scale Standard Error 0.6	-4.0 units on a scale Standard Error 0.6	-4.0 units on a scale Standard Error 0.6
Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score 8 Week Change (n=47, n=50, n=48)	-3.3 units on a scale Standard Error 0.7	-4.8 units on a scale Standard Error 0.6	-4.8 units on a scale Standard Error 0.7

SECONDARY outcome

Timeframe: baseline, 4, 8, and 12 weeks

The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants by mouth once a day	Tadalafil n=50 Participants 5 mg by mouth once a day	Tamsulosin n=49 Participants 0.2 mg by mouth once a day
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore Baseline (n=50, n=50, n=49)	6.7 units on a scale Standard Deviation 2.0	6.7 units on a scale Standard Deviation 2.7	6.5 units on a scale Standard Deviation 2.6
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore 4 Week Change (n=50, n=49, n=49)	-0.8 units on a scale Standard Deviation 2.1	-1.4 units on a scale Standard Deviation 2.4	-1.7 units on a scale Standard Deviation 2.1
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore 8 Week Change (n=47, n=50, n=48)	-0.9 units on a scale Standard Deviation 2.0	-1.6 units on a scale Standard Deviation 2.5	-1.9 units on a scale Standard Deviation 2.3
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore 12 Week Change (n=47, n=48, n=48)	-1.6 units on a scale Standard Deviation 2.1	-2.2 units on a scale Standard Deviation 2.4	-1.8 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: baseline, 4, 8, and 12 weeks

The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants by mouth once a day	Tadalafil n=50 Participants 5 mg by mouth once a day	Tamsulosin n=49 Participants 0.2 mg by mouth once a day
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore Baseline (n=50, n=50, n=49)	10.6 units on a scale Standard Deviation 3.7	10.4 units on a scale Standard Deviation 3.8	11.2 units on a scale Standard Deviation 3.7
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore 4 Week Change (n=50, n=49, n=49)	-2.0 units on a scale Standard Deviation 4.0	-2.6 units on a scale Standard Deviation 3.1	-2.4 units on a scale Standard Deviation 3.1
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore 8 Week Change (n=47, n=50, n=48)	-2.3 units on a scale Standard Deviation 4.1	-3.1 units on a scale Standard Deviation 3.1	-3.1 units on a scale Standard Deviation 3.8
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore 12 Week Change (n=47, n=48, n=48)	-2.7 units on a scale Standard Deviation 3.6	-3.6 units on a scale Standard Deviation 3.4	-3.9 units on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: baseline, 4, 8, and 12 weeks

IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia).

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants by mouth once a day	Tadalafil n=50 Participants 5 mg by mouth once a day	Tamsulosin n=49 Participants 0.2 mg by mouth once a day
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore Baseline (n=50, n=50, n=49)	2.0 units on a scale Standard Deviation 1.1	1.8 units on a scale Standard Deviation 1.0	1.7 units on a scale Standard Deviation 1.0
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore 4 Week Change (n=50, n=49, n=49)	-0.3 units on a scale Standard Deviation 0.9	-0.4 units on a scale Standard Deviation 0.9	-0.3 units on a scale Standard Deviation 1.0
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore 8 Week Change (n=47, n=50, n=48)	-0.4 units on a scale Standard Deviation 0.7	-0.4 units on a scale Standard Deviation 1.0	-0.4 units on a scale Standard Deviation 1.2
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore 12 Week Change (n=47, n=48, n=48)	-0.5 units on a scale Standard Deviation 0.9	-0.5 units on a scale Standard Deviation 0.9	-0.5 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: baseline, 12 weeks

The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit.

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants by mouth once a day	Tadalafil n=49 Participants 5 mg by mouth once a day	Tamsulosin n=48 Participants 0.2 mg by mouth once a day
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) Baseline	6.2 units on a scale Standard Deviation 2.8	6.1 units on a scale Standard Deviation 2.9	6.2 units on a scale Standard Deviation 3.1
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) 12 Week Change	-2.0 units on a scale Standard Deviation 2.7	-2.2 units on a scale Standard Deviation 2.9	-1.7 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 12 weeks

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). Scores were combined to provide number of participants who indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3).

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants by mouth once a day	Tadalafil n=49 Participants 5 mg by mouth once a day	Tamsulosin n=48 Participants 0.2 mg by mouth once a day
Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies Worse	1 participants	1 participants	3 participants
Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies No Change	10 participants	5 participants	7 participants
Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies Better	37 participants	43 participants	38 participants

SECONDARY outcome

Timeframe: 12 weeks

Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3).

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants by mouth once a day	Tadalafil n=49 Participants 5 mg by mouth once a day	Tamsulosin n=48 Participants 0.2 mg by mouth once a day
Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies Worse	0 participants	0 participants	4 participants
Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies No Change	5 participants	8 participants	4 participants
Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies Better	43 participants	41 participants	40 participants

SECONDARY outcome

Timeframe: baseline, 12 weeks

Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants by mouth once a day	Tadalafil n=50 Participants 5 mg by mouth once a day	Tamsulosin n=49 Participants 0.2 mg by mouth once a day
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary Baseline Waking Voids	48.2 average number per week Standard Deviation 11.2	46.9 average number per week Standard Deviation 11.1	48.4 average number per week Standard Deviation 16.9
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary 12 Week Change Waking Voids	-0.3 average number per week Standard Deviation 8.7	-2.1 average number per week Standard Deviation 8.7	-1.3 average number per week Standard Deviation 7.6
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary Baseline Sleeping Voids	10.3 average number per week Standard Deviation 7.8	9.8 average number per week Standard Deviation 6.7	7.9 average number per week Standard Deviation 5.4
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary 12 Week Change Sleeping Voids	-1.3 average number per week Standard Deviation 3.5	-2.3 average number per week Standard Deviation 3.8	-1.4 average number per week Standard Deviation 4.0
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary Baseline Total Voids	58.6 average number per week Standard Deviation 13.0	56.7 average number per week Standard Deviation 13.3	56.3 average number per week Standard Deviation 19.2
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary 12 Week Change Total Voids	-1.6 average number per week Standard Deviation 9.2	-4.4 average number per week Standard Deviation 9.7	-2.7 average number per week Standard Deviation 8.9

SECONDARY outcome

Timeframe: baseline, 12 weeks

A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants by mouth once a day	Tadalafil n=50 Participants 5 mg by mouth once a day	Tamsulosin n=49 Participants 0.2 mg by mouth once a day
Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary Baseline	0.8 average number per week Standard Deviation 3.6	1.1 average number per week Standard Deviation 5.4	1.6 average number per week Standard Deviation 5.0
Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary 12 Week Change	-0.3 average number per week Standard Deviation 3.5	0.7 average number per week Standard Deviation 2.5	-0.3 average number per week Standard Deviation 4.9

SECONDARY outcome

Timeframe: baseline, 12 weeks

A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination).

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants by mouth once a day	Tadalafil n=50 Participants 5 mg by mouth once a day	Tamsulosin n=49 Participants 0.2 mg by mouth once a day
Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary Baseline Terminal Micturation Dribble	68.7 average number per week Standard Deviation 35.8	69.8 average number per week Standard Deviation 37.0	77.5 average number per week Standard Deviation 29.9
Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary 12 Week Change Terminal Micturation Dribble	-11.7 average number per week Standard Deviation 36.9	1.6 average number per week Standard Deviation 31.9	-8.5 average number per week Standard Deviation 33.1
Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary Baseline Post Micturation Dribble	14.3 average number per week Standard Deviation 27.0	17.8 average number per week Standard Deviation 29.8	25.5 average number per week Standard Deviation 32.6
Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary 12 Week Change Post Micturation Dribble	-0.8 average number per week Standard Deviation 29.5	-4.8 average number per week Standard Deviation 27.4	-7.6 average number per week Standard Deviation 34.9

SECONDARY outcome

Timeframe: baseline, 12 weeks

Qmax: defined as the peak urine flow rate (measured in milliliters per second \[mL/second\] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter).

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants by mouth once a day	Tadalafil n=49 Participants 5 mg by mouth once a day	Tamsulosin n=48 Participants 0.2 mg by mouth once a day
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) Baseline Qmax	10.5 milliliters per second Standard Deviation 3.6	11.4 milliliters per second Standard Deviation 3.2	11.7 milliliters per second Standard Deviation 4.6
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) 12 Week Change Qmax	2.8 milliliters per second Standard Deviation 5.6	2.4 milliliters per second Standard Deviation 5.2	1.9 milliliters per second Standard Deviation 4.8
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) Baseline Qmean	5.7 milliliters per second Standard Deviation 2.3	6.1 milliliters per second Standard Deviation 2.1	6.2 milliliters per second Standard Deviation 3.0
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) 12 Week Change Qmean	2.0 milliliters per second Standard Deviation 3.1	1.5 milliliters per second Standard Deviation 2.9	1.0 milliliters per second Standard Deviation 3.4

SECONDARY outcome

Timeframe: baseline, 12 weeks

Vcomp, defined as the volume of voided urine (measured in milliliters \[mL\]).

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants by mouth once a day	Tadalafil n=49 Participants 5 mg by mouth once a day	Tamsulosin n=48 Participants 0.2 mg by mouth once a day
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) Baseline	220.0 milliliters Standard Deviation 67.7	233.2 milliliters Standard Deviation 86.7	236.6 milliliters Standard Deviation 78.4
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) 12 Week Change	21.4 milliliters Standard Deviation 128.9	19.7 milliliters Standard Deviation 109.2	23.9 milliliters Standard Deviation 89.3

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Tadalafil

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Tamsulosin

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo by mouth once a day	Tadalafil 5 mg by mouth once a day	Tamsulosin 0.2 mg by mouth once a day
Cardiac disorders Acute myocardial infarction	0.00% 0/51	0.00% 0/51	2.0% 1/49 • Number of events 1
Gastrointestinal disorders Inguinal hernia	0.00% 0/51	0.00% 0/51	2.0% 1/49 • Number of events 1
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/51	2.0% 1/51 • Number of events 1	0.00% 0/49
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/51	2.0% 1/51 • Number of events 1	0.00% 0/49
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/51	2.0% 1/51 • Number of events 1	0.00% 0/49

Other adverse events

Other adverse events
Measure	Placebo by mouth once a day	Tadalafil 5 mg by mouth once a day	Tamsulosin 0.2 mg by mouth once a day
Gastrointestinal disorders Dyspepsia	0.00% 0/51	0.00% 0/51	2.0% 1/49 • Number of events 1
Gastrointestinal disorders Epigastric discomfort	0.00% 0/51	0.00% 0/51	2.0% 1/49 • Number of events 1
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/51	0.00% 0/51	2.0% 1/49 • Number of events 1
General disorders Chest pain	0.00% 0/51	0.00% 0/51	2.0% 1/49 • Number of events 1
Infections and infestations Nasopharyngitis	0.00% 0/51	2.0% 1/51 • Number of events 1	10.2% 5/49 • Number of events 5
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/51	2.0% 1/51 • Number of events 1	2.0% 1/49 • Number of events 1
Injury, poisoning and procedural complications Skin laceration	0.00% 0/51	0.00% 0/51	2.0% 1/49 • Number of events 1
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/51	0.00% 0/51	2.0% 1/49 • Number of events 1
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/51	0.00% 0/51	2.0% 1/49 • Number of events 1
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/51	3.9% 2/51 • Number of events 2	2.0% 1/49 • Number of events 1
Nervous system disorders Headache	2.0% 1/51 • Number of events 1	0.00% 0/51	0.00% 0/49
Psychiatric disorders Insomnia	2.0% 1/51 • Number of events 1	0.00% 0/51	0.00% 0/49
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/51	2.0% 1/51 • Number of events 1	0.00% 0/49
Vascular disorders Flushing	0.00% 0/51	2.0% 1/51 • Number of events 1	0.00% 0/49

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