Trial Outcomes & Findings for Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily (NCT 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

325 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2010-11-17

Participant Flow

Participant milestones

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

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

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=5 Participants	64.6 years STANDARD_DEVIATION 10.03 • n=7 Participants	64.9 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	161 Participants n=5 Participants	164 Participants n=7 Participants	325 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=5 Participants	44 Participants n=7 Participants	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	115 Participants n=5 Participants	120 Participants n=7 Participants	235 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	146 Participants n=5 Participants	150 Participants n=7 Participants	296 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	52 participants n=7 Participants	102 participants n=5 Participants
Region of Enrollment South America	43 participants n=5 Participants	43 participants n=7 Participants	86 participants n=5 Participants
Region of Enrollment Europe	68 participants n=5 Participants	69 participants n=7 Participants	137 participants n=5 Participants
Body Mass Index (BMI)	27.1 kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.82 • n=5 Participants	28.4 kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 4.21 • n=7 Participants	27.7 kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 4.07 • n=5 Participants
Baseline Lower Urinary Tract Symptoms (LUTS) Severity Moderate	100 participants n=5 Participants	110 participants n=7 Participants	210 participants n=5 Participants
Baseline Lower Urinary Tract Symptoms (LUTS) Severity Severe	61 participants n=5 Participants	54 participants n=7 Participants	115 participants n=5 Participants
Peak Urine Flow Rate (Qmax) Category <10 mL/sec	54 participants n=5 Participants	62 participants n=7 Participants	116 participants n=5 Participants
Peak Urine Flow Rate (Qmax) Category 10-15 mL/sec	78 participants n=5 Participants	67 participants n=7 Participants	145 participants n=5 Participants
Peak Urine Flow Rate (Qmax) Category >15 mL/sec	20 participants n=5 Participants	24 participants n=7 Participants	44 participants n=5 Participants
Post-void Residual Volume (PVR)	44.9 mL STANDARD_DEVIATION 44.87 • n=5 Participants	63.3 mL STANDARD_DEVIATION 59.88 • n=7 Participants	54.2 mL STANDARD_DEVIATION 53.70 • n=5 Participants
Prostate-Specific Antigen (PSA)	2.0 ng/mL STANDARD_DEVIATION 1.75 • n=5 Participants	2.2 ng/mL STANDARD_DEVIATION 1.72 • n=7 Participants	2.1 ng/mL STANDARD_DEVIATION 1.74 • n=5 Participants
Erectile Dysfunction (ED) Yes	112 participants n=5 Participants	112 participants n=7 Participants	224 participants n=5 Participants
Erectile Dysfunction (ED) No	49 participants n=5 Participants	52 participants n=7 Participants	101 participants n=5 Participants
ED Severity Mild	34 participants n=5 Participants	40 participants n=7 Participants	74 participants n=5 Participants
ED Severity Moderate	61 participants n=5 Participants	59 participants n=7 Participants	120 participants n=5 Participants
ED Severity Severe	17 participants n=5 Participants	13 participants n=7 Participants	30 participants n=5 Participants
ED Duration <1 year	14 participants n=5 Participants	17 participants n=7 Participants	31 participants n=5 Participants
ED Duration >=1 year	98 participants n=5 Participants	95 participants n=7 Participants	193 participants n=5 Participants
Sexually Active with a Female Partner Yes	128 participants n=5 Participants	129 participants n=7 Participants	257 participants n=5 Participants
Sexually Active with a Female Partner No	33 participants n=5 Participants	35 participants n=7 Participants	68 participants n=5 Participants
Expect to Remain Sexually Active Yes	127 participants n=5 Participants	129 participants n=7 Participants	256 participants n=5 Participants
Expect to Remain Sexually Active No	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Patient Global Impression of Severity (PGI-S) Normal	5 participants n=5 Participants	8 participants n=7 Participants	13 participants n=5 Participants
Patient Global Impression of Severity (PGI-S) Mild	35 participants n=5 Participants	27 participants n=7 Participants	62 participants n=5 Participants
Patient Global Impression of Severity (PGI-S) Moderate	102 participants n=5 Participants	105 participants n=7 Participants	207 participants n=5 Participants
Patient Global Impression of Severity (PGI-S) Severe	19 participants n=5 Participants	24 participants n=7 Participants	43 participants n=5 Participants
Clinician Global Impression of Severity (CGI-S) Normal	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Clinician Global Impression of Severity (CGI-S) Mild	36 participants n=5 Participants	37 participants n=7 Participants	73 participants n=5 Participants
Clinician Global Impression of Severity (CGI-S) Moderate	104 participants n=5 Participants	95 participants n=7 Participants	199 participants n=5 Participants
Clinician Global Impression of Severity (CGI-S) Severe	21 participants n=5 Participants	31 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: 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.

Outcome measures

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

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

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 weeks

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

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 weeks

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

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 weeks

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

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 weeks

Population: 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

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 weeks

Population: 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

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 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 4-No Change	36 Participants	59 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 week

Population: 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

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 Weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

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

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 weeks

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

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 weeks

The amount of urine remaining in the bladder after void completion.

Outcome measures

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

Serious events: 2 serious events

Other events: 41 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

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

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

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60