Study to Treat Patients Who Have Signs and Symptoms of Be... | NCT00827242

ID	Type	Description	Link
H6D-MC-LVHJ	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Tadalafil	Experimental		Drug: tadalafil
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Following a 4-week placebo lead-in period, subjects received placebo tablet by mouth once daily over a 12-week period.	Placebo

Measure	Description	Time Frame
Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS)	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.	Baseline, 12 weeks

Measure	Description	Time Frame
Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men 45 years of age or older with Benign Prostatic Hyperplasia (BPH) also referred to as BPH-LUTS [lower urinary tract symptoms] based on the disease diagnostic criteria at the start of study.
Provide signed informed consent at the start of the study.
Have not taken Finasteride therapy for at least 3 months before study drug is dispensed and Dutasteride therapy for at least 6 months before study drug is dispensed.
Have not taken other BPH therapy (including herbal preparations), overactive bladder (OAB) therapy, or erectile dysfunction (ED) therapy for at least 4 weeks prior to study drug is dispensed.
Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments anytime during the study
Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
Have reduced peak urine flow rate when study drug is dispensed (measured by a special toilet equipment).
Demonstrate compliance with study drug administration requirements.

Exclusion Criteria:

Treated with nitrates for a cardiac conditions.
Have unstable angina or angina that requires treatment.
Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
Have very high or very low blood pressure
Have problems with kidneys, liver, or nervous system.
Have uncontrolled diabetes.
Have had a stroke or a significant injury to brain or spinal cord.
Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (Prostate-Specific Antigen [PSA] greater than 10 nanograms/milliliter [ng/ml] at the start of study).

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Huntsville	Alabama	35801

PubMed Identifier	Type	Citation	Retractions
26299520	Derived	Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.
21871706

ID	Title	Description
FG000	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.
FG001	Placebo

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.1± 8.43 BG00164.6± 10.03 BG00264.9± 9.26

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00046 BG00144 BG002

Race (NIH/OMB)

If a subject reported multiple race categories, he was counted as "more than one race", but not in any single category.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0009 BG0018

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00050 BG00152 BG002

Body Mass Index (BMI)

BMI is an estimate of body fat based on body weight divided by height squared.

Mean

Standard Deviation

kilogram (kg)/meter (m)^2

Title

Denominators

Categories

Title	Measurements
	BG00027.1± 3.82 BG00128.4± 4.21

Baseline Lower Urinary Tract Symptoms (LUTS) Severity

Baseline LUTS severity was assessed using the International Prostate Symptom Score (IPSS). 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. Moderate was considered an IPSS score <20. Severe was considered an IPSS>=20.

Number

participants

Title

Denominators

Categories

Moderate

Title	Measurements
	BG000100 BG001

Peak Urine Flow Rate (Qmax) Category

Participants were categorized by Qmax: defined as the peak urine flow rate (measured in mL/second using standard calibrated flowmeter). Based on measurements from 305 randomized participants with a valid uroflowmetry assessment. Uroflowmetry assessments were considered valid and the data were included in statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 mL to <=550 mL and the volume of voided urine (Vcomp) was >=125 mL.

Number

participants

Title

Denominators

Categories

<10 mL/sec

Title	Measurements
	BG00054 BG001

Post-void Residual Volume (PVR)

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

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00044.9± 44.87 BG00163.3± 59.88

Prostate-Specific Antigen (PSA)

PSA is a tumor marker associated with prostate cancer. The participant population includes all randomized subjects with non-missing data (n=164 for placebo and n=160 for tadalafil).

Mean

Standard Deviation

ng/mL

Title

Denominators

Categories

Title	Measurements
	BG0002.0± 1.75 BG001

Erectile Dysfunction (ED)

ED is defined as a consistent change in the quality of erection adversely affecting subject satisfaction with sexual intercourse.

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG000112 BG001112

ED Severity

ED is defined as a consistent change in the quality of erection adversely affecting subject satisfaction with sexual intercourse. Severity is based on investigator's opinion. Participant population includes all randomized subjects with ED.

Number

participants

Title

Denominators

Categories

Mild

Title	Measurements
	BG00034 BG001

ED Duration

ED is defined as a consistent change in the quality of erection adversely affecting subject satisfaction with sexual intercourse. Participant population includes all randomized subjects with ED.

Number

participants

Title

Denominators

Categories

<1 year

Title	Measurements
	BG00014 BG00117

Sexually Active with a Female Partner

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG000128 BG001129 BG002

Expect to Remain Sexually Active

Participant population is based on number of randomized subjects who are reported to be sexually active with a female partner.

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG000127 BG001129

Patient Global Impression of Severity (PGI-S)

Measures patient's perception of severity of illness at the time of assessment. The responses were grouped into an ordinal scale with 4 categories: normal; mild; moderate; and severe, and were based on postponing urination, straining to begin urination, a weak urinary stream, stopping and restarting urination several times when urinating, prolonged urination with the end of urine flow slowing to a trickle, bladder not feeling emptied after urinating, having to urinate again less than two hours after the last time urinating, accidental urinary leakage, or having to get up at night to urinate.

Number

participants

Title

Denominators

Categories

Normal

Title	Measurements
	BG0005 BG001

Clinician Global Impression of Severity (CGI-S)

Measures clinician's perception of severity of illness at the time of assessment. The responses were grouped into an ordinal scale with 4 categories: normal; mild; moderate; and severe, and were based on postponing urination, straining to begin urination, a weak urinary stream, stopping and restarting urination several times when urinating, prolonged urination with the end of urine flow slowing to a trickle, bladder not feeling emptied after urinating, having to urinate again less than two hours after the last time urinating, accidental urinary leakage, or having to get up at night to urinate.

Number

participants

Title

Denominators

Categories

Normal

Title	Measurements
	BG0000 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS)

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.

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.

Posted

Least Squares Mean

Standard Error

Units on a Scale

Baseline, 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000160 OG001164

Title

Denominators

Categories

Title	Measurements
	OG000-5.6± 0.47 OG001-3.6± 0.47

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.004	The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.	Mean Difference (Final Values)	-1.9	Standard Error of the Mean	0.66		95						No	Superiority or Other

Secondary

Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index

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.

The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4.

Posted

Least Squares Mean

Standard Error

Units on a Scale

Baseline, 4 weeks

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index

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.

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.

Posted

Least Squares Mean

Standard Error

Units on a Scale

Baseline, 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore

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.

The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.

Posted

Least Squares Mean

Standard Error

Units on a Scale

Baseline, 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore

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.

Posted

Least Squares Mean

Standard Error

Units on a Scale

Baseline, 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Nocturia Question

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.

Posted

Least Squares Mean

Standard Error

Units on a Scale

Baseline, 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units

Secondary

Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index

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.

Posted

Least Squares Mean

Standard Error

Units on a Scale

Baseline, 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories

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).

The analysis population includes all subjects who were randomized, started study medication, and had non-missing data.

Posted

Number

Participants

12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories

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).

All values are based on the number of subjects in the analysis population with non-missing data.

Posted

Number

Participants

12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 1 Week, International Prostate Symptom Score (IPSS)

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.

The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 1.

Posted

Least Squares Mean

Standard Error

Units on a Scale

Baseline, 1 week

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline to 4 Weeks, International Prostate Symptom Score (IPSS)

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.

The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4.

Posted

Least Squares Mean

Standard Error

Units on a Scale

Baseline, 4 Weeks

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline to 12 Weeks, International Index of Erectile Function (IIEF)- Erectile Function (EF) Domain Scores

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.

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.

Posted

Least Squares Mean

Standard Error

Units on a Scale

Baseline, 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline to 12 Weeks, Peak Flow Rate (Qmax) by Uroflowmetry

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.

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).

Posted

Mean

Standard Deviation

mL/sec

Baseline, 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Change From Baseline to 12 Weeks, Mean Flow Rate (Qmean) by Uroflowmetry

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.

Posted

Mean

Standard Deviation

mL/sec

Baseline, 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Change From Baseline to 12 Weeks, Voided Volume (Vcomp) by Uroflowmetry

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.

Posted

Mean

Standard Deviation

Baseline, 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Change From Baseline to 12 Weeks, Postvoid Residual (PVR) Volume

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

Posted

Mean

Standard Deviation

Baseline, 12 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrioventricular block first degree	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Bundle branch block right	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Deafness	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Hypothyroidism	Endocrine disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0011 events1 affected164 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0011 events1 affected164 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0012 events2 affected164 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0011 events1 affected164 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected161 at risk EG0010 events0 affected164 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Toothache	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0011 events1 affected164 at risk
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected161 at risk EG0012 events1 affected164 at risk
Influenza like illness	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0011 events1 affected164 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Influenza	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0014 events3 affected164 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected161 at risk EG0014 events3 affected164 at risk
Sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected161 at risk EG0010 events0 affected164 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Wound infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Vertebral injury	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Endoscopy	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Hepatic enzyme increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Prostatic specific antigen increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected161 at risk EG0010 events0 affected164 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0005 events5 affected161 at risk EG0014 events4 affected164 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected161 at risk EG0010 events0 affected164 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected161 at risk EG0010 events0 affected164 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0011 events1 affected164 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected161 at risk EG0010 events0 affected164 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0006 events6 affected161 at risk EG0011 events1 affected164 at risk
Anxiety	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Insomnia	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected161 at risk EG0010 events0 affected164 at risk
Dysuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Nocturia	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Urinary retention	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0012 events2 affected164 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0012 events2 affected164 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected161 at risk EG0011 events1 affected164 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected161 at risk EG0013 events3 affected164 at risk

ID	Term
D011470	Prostatic Hyperplasia
D012816	Signs and Symptoms
D006965	Hyperplasia
D005832	Genital Diseases, Male
D011469	Prostatic Diseases

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D013568	Pathological Conditions, Signs and Symptoms
D010335	Pathologic Processes

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D026121	Indole Alkaloids
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006575	Heterocyclic Compounds, 3-Ring

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			2	161	41	161
EG001	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.			0	164	36	164

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	This event resulted in death.	EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk
Endocarditis	Infections and infestations	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected161 at risk EG0010 events0 affected164 at risk