CompletedNCT00855582COMORBID©Updated Jul 28, 2011Results posted

A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia

A Phase 3 interventional study of Tadalafil and Placebo in Erectile Dysfunction and Benign Prostatic Hyperplasia, sponsored by Eli Lilly and Company. Completed at 52 sites in 9 countries. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2011-07-28.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 606
Allocation: Randomized
Ages: 45 Years and older
Sex: Male

Study summary

Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.

Conditions studied

Erectile Dysfunction
Benign Prostatic Hyperplasia

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Keywords

Erectile Dysfunction
Benign Prostatic Hyperplasia

In context

Erectile Dysfunction

682 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.

This study's enrollment of 606 is above the median of 72 across 541 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

Have BPH Lower Urinary Tract Symptoms (LUTS) based on the disease diagnostic criteria at 1st screening.
Have a history of ED based on the disease diagnostic criteria at 1st screening.
Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 at 2nd screening.
Have bladder outlet obstruction as defined by a Peak Urine Flow Rate (Qmax) of greater than or equal to 4 to less than or equal to 15 milliliter (mL)/second (sec) (from a prevoid total bladder volume as assessed by ultrasound of greater than or equal to 150 to less than or equal to 550 mL and a minimum voided volume of 125 mL) at 2nd screening.
Make at least 4 sexual intercourse attempts during the 4-weeks after 2nd screening as recorded in the Sexual Encounter Profile (SEP) diary.
Are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study.
Agree not to use any other approved or experimental BPH, overactive bladder (OAB), or ED treatments as indicated in the protocol at any time during the study.
Have not taken treatments indicated in the protocol prior to the 2nd screening.

Exclusion criteria

Exclusion Criteria:

Current treatment with nitrates.
Prostate-specific antigen (PSA) greater than 10.0 nanogram (ng)/mL at 1st screening.
PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at 1st screening if prostate malignancy has not been ruled out to the satisfaction of a urologist.
Clinical evidence of prostate cancer.
Bladder postvoid residual volume (PVR) greater than or equal to 300 mL by ultrasound determination at 1st screening.
History or clinical evidence of certain pelvic, bladder, urinary tract, or urinary retention conditions described in the protocol.
Lower urinary tract instrumentation (including prostate biopsy) within 30 days of 1st screening.
Clinical evidence of severe hepatic impairment at 1st screening.
Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease or multiple sclerosis).
History of significant renal insufficiency as defined by the protocol.
History of ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease.
Presence of penile deformity judged by the investigator to be clinically significant.
History of certain cardiac or cardiovascular conditions described in the protocol.
History of resuscitated cardiac arrest.
Current treatment with certain medications described in the protocol.
Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study.
History of significant central nervous system injuries (including stroke or spinal cord injury) within 6 months of 1st screening.
Glycosylated hemoglobin (HbA1c) greater than 9% at 1st screening.
Prior treatment with phosphodiesterase type 5 (PDE5) inhibitors judged by the investigator to be ineffective. However, if the investigator judges that a subject's lack of response to as-needed PDE5 inhibitors is the result of inadequate coordination between dosing and sexual activity with a treatment, the subject may be enrolled.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 606 participants (actual)

Study arms

Experimental
Tadalafil 2.5 mg
Drug: Tadalafil
Experimental
Tadalafil 5 mg
Drug: Tadalafil
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugTadalafil
tablet once daily by mouth for 12 weeks.
Also known as: Cialis, LY450190
DrugPlacebo
Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.

What researchers measure

Primary outcomes

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)
Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)
Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks

Secondary outcomes

Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of Yes responses per the number of sexual attempts for a participant during a study period. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)
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. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)
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. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint
The Modified IPSS is the total IPSS collected at 2 weeks post-baseline. The total IPSS is obtained by combining the scores of the responses to component questions 1 through 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 ANCOVA. The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 2 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 4 weeks, 8 weeks
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint
Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 4 weeks, 8 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 4 weeks, 8 weeks
Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint
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. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 4 weeks, 8 weeks
Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. The obstructive subscore ranges from 0 to 20 with a higher score representing greater obstruction. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint
IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. The irritative subscore ranges from 0 to 15 with a higher score representing more irritative 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12
The IPSS Nocturia question (Question 7) measures the number of times needed to get up at night to urinate. Scores range from 0 (none) to 5 (5 or more times). 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint
Assessment of quality of life (QoL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint
Self-reported overall satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 13 and 14. Each question is scored from 1 through 5, with a possible total score of 2 through 10. Higher scores represent greater satisfaction. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint
Self-reported intercourse satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 6, 7 and 8. Each question is scored from 0 through 5 with a possible total score of 0 through 15. Higher score represent greater satisfaction. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint
IIEF Question 3 asks how often a subject was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint
IIEF Question 4 asks whether how often a subject was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2, "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4, "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5, "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time frame: Baseline, 12 weeks
Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint
A scale that measures the patient's perception of urinary symptoms at endpoint compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).
Time frame: 12 weeks
Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint
A scale that measures clinician's rating of the total change in the patient's urinary symptoms at endpoint compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).
Time frame: 12 weeks
Erectile Function General Assessment Questionnaire (EF-GAQ)
The EF-GAQ consisted of two questions: (1) Has the treatment you have been taking during this study improved your erections? and (2) If yes, has the treatment improved your ability to engage in sexual activity? Each question has a Yes/No response.
Time frame: 12 weeks
Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint
Qmax is 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.
Time frame: Baseline, 12 weeks
Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint
Qmean is defined as the average urine flow rate (measured in milliliters per second \[mL/second\] 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.
Time frame: Baseline, 12 weeks
Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint
Vcomp is defined as the volume of urine voided (measures in mL using a 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.
Time frame: Baseline, 12 weeks

Results

Posted Jun 30, 2011

Limitations and caveats

P-values for the peak urine flow rate outcome were corrected in this record after an error was identified.

Participant flow

Participant flow — Overall Study
Milestone	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Started	198	208	200
Completed	172	184	170
Not completed	26	24	30
Withdrew: Adverse event	2	6	3
Withdrew: Death	1	0	0
Withdrew: Lack of efficacy	1	3	8
Withdrew: Lost to follow-up	1	3	1
Withdrew: Physician decision	0	0	1
Withdrew: Protocol violation	6	2	6
Withdrew: Entry criteria not met	8	6	3
Withdrew: Withdrawal by subject	7	4	8

Outcome measures

PrimaryChange From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)

The total IPSS is obtained by combining the scores of the responses to component questions 1 through 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)
units on a scale	Tadalafil 5 mg	Placebo
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)	-6.1 ± 0.43	-3.8 ± 0.45

Statistical analysis

Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.) · Median difference (final values): -2.3ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

PrimaryChange From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)

Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)
units on a scale	Tadalafil 5 mg	Placebo
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)	6.5 ± 0.49	1.8 ± 0.51

Statistical analysis

Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.) · Mean difference (final values): 4.7ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

PrimaryChange From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)
units on a scale	Tadalafil 2.5 mg	Placebo
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)	-4.6 ± 0.44	-3.8 ± 0.45

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = 0.181 (Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.) · Mean difference (final values): -0.8ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

PrimaryChange From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)
units on a scale	Tadalafil 2.5 mg	Placebo
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)	5.2 ± 0.5	1.8 ± 0.51

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.) · Mean difference (final values): 3.4ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)

Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of Yes responses per the number of sexual attempts for a participant during a study period. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · percentage of Yes responses

Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)
percentage of Yes responses	Tadalafil 5 mg	Placebo
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)	31.7 ± 2.07	12.0 ± 2.14

Statistical analysis

Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.) · Mean difference (final values): 19.7ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)

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. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on scale

Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)
units on scale	Tadalafil 5 mg	Placebo
Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)	-2.1 ± 0.19	-1.2 ± 0.20

Statistical analysis

Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.) · Mean difference (final values): -0.9ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)

Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · percentage of yes responses

Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)
percentage of yes responses	Tadalafil 2.5 mg	Placebo
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)	24.6 ± 2.11	12.0 ± 2.14

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.) · Mean difference (final values): 12.5ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)
units on a scale	Tadalafil 2.5 mg	Placebo
Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)	-1.6 ± 0.20	-1.2 ± 0.20

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = 0.156 (Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.) · Mean difference (final values): -0.4ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint

The Modified IPSS is the total IPSS collected at 2 weeks post-baseline. The total IPSS is obtained by combining the scores of the responses to component questions 1 through 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 ANCOVA. The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 2 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint
units on a scale	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint	-2.8 ± 0.39	-4.0 ± 0.38	-2.2 ± 0.38

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = 0.226 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): -0.6ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): -1.8ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint

Time frame:: Baseline, 4 weeks, 8 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint
units on a scale	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Week 4 Change (n=184, 197, 183)	-3.4 ± 0.39	-5.5 ± 0.38	-2.6 ± 0.40
Week 8 Change (n=174, 192, 178)	-4.5 ± 0.43	-5.8 ± 0.41	-3.8 ± 0.43

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = 0.121 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline) · Mean difference (final values): -0.8ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 2.5 mg vs Placebo · ANCOVA · p = 0.169 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline) · Mean difference (final values): -0.8ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline) · Mean difference (final values): -2.9ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline) · Mean difference (final values): -2.1ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint

Time frame:: Baseline, 4 weeks, 8 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint
units on a scale	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Week 4 Change (n=186, 197, 183)	4.2 ± 0.44	6.1 ± 0.43	1.0 ± 0.45
Week 8 Change (n=176, 192, 178)	4.9 ± 0.49	6.6 ± 0.48	1.8 ± 0.52

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline) · Mean difference (final values): 3.1ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline) · Mean difference (final values): 3.1ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline) · Mean difference (final values): 5.0ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline) · Mean difference (final values): 4.8ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint

Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 4 weeks, 8 weeks
Reported as:: Least squares mean · percentage of yes responses

Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint
percentage of yes responses	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Week 4 Change (n=180, 190, 180)	22.3 ± 2.31	30.7 ± 2.27	6.2 ± 2.35
Week 8 Change (n=172, 187, 171)	22.9 ± 2.16	31.7 ± 2.11	10.9 ± 2.21

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline) · Mean difference (final values): 16.1ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline) · Mean difference (final values): 12.0ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline) · Mean difference (final values): 24.5ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline) · Mean difference (final values): 20.9ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint

Time frame:: Baseline, 4 weeks, 8 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint
units on a scale	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Week 4 Change (n=186, 197, 183)	-1.0 ± 0.17	-1.5 ± 0.16	-0.7 ± 0.17
Week 8 Change (n=175, 192, 177)	-1.4 ± 0.18	-1.8 ± 0.17	-1.2 ± 0.18

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = 0.215 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline) · Mean difference (final values): -0.3ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 2.5 mg vs Placebo · ANOVA · p = 0.325 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline) · Mean difference (final values): -0.2ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline) · Mean difference (final values): -0.9ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = 0.011 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline) · Mean difference (final values): -0.6ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint

IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. The obstructive subscore ranges from 0 to 20 with a higher score representing greater obstruction. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint
units on a scale	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint	-2.7 ± 0.28	-3.6 ± 0.28	-2.2 ± 0.29

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = 0.230 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): -0.5ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): -1.4ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint

IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. The irritative subscore ranges from 0 to 15 with a higher score representing more irritative 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint
units on a scale	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint	-1.9 ± 0.2	-2.5 ± 0.19	-1.6 ± 0.20

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = 0.191 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): -0.3ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): -0.9ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in International Prostate Symptom Score Nocturia Question at Week 12

The IPSS Nocturia question (Question 7) measures the number of times needed to get up at night to urinate. Scores range from 0 (none) to 5 (5 or more times). 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12
units on a scale	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12	-0.5 ± 0.08	-0.6 ± 0.07	-0.5 ± 0.08

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = 0.763 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): -0.0ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = 0.075 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): -0.2ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint

Assessment of quality of life (QoL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint
units on a scale	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint	-0.9 ± 0.10	-1.0 ± 0.10	-0.8 ± 0.11

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = 0.384 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): -0.1ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = 0.082 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): -0.3ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint

Self-reported overall satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 13 and 14. Each question is scored from 1 through 5, with a possible total score of 2 through 10. Higher scores represent greater satisfaction. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint
units on a scale	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint	1.8 ± 0.16	2.4 ± 0.16	0.5 ± 0.16

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 1.3ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 1.9ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint

Self-reported intercourse satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 6, 7 and 8. Each question is scored from 0 through 5 with a possible total score of 0 through 15. Higher score represent greater satisfaction. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint
units on a scale	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint	1.6 ± 0.23	2.0 ± 0.22	0.2 ± 0.23

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 1.5ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 1.9ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint

IIEF Question 3 asks how often a subject was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint
units on a scale	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint	0.9 ± 0.10	1.1 ± 0.10	0.2 ± 0.10

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 0.7ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 0.9ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint

IIEF Question 4 asks whether how often a subject was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint
units on a scale	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint	0.9 ± 0.11	1.3 ± 0.10	0.4 ± 0.11

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 0.5ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 0.9ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint

Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2, "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · percentage of yes responses

Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint
percentage of yes responses	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint	21.4 ± 1.82	25.1 ± 1.78	9.3 ± 1.84

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 12.1ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 15.8ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint

Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4, "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · percentage of yes responses

Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint
percentage of yes responses	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint	26.6 ± 2.48	39.4 ± 2.46	9.6 ± 2.61

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 16.9ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 29.7ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryChange From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5

Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5, "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. 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, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · percentage of yes responses

Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5
percentage of yes responses	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5	23.7 ± 2.49	38.2 ± 2.48	9.9 ± 2.63

Statistical analysis

Tadalafil 2.5 mg vs Placebo · ANCOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 13.8ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Tadalafil 5 mg vs Placebo · ANOVA · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.) · Mean difference (final values): 28.4ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

SecondaryPatient Global Impression of Improvement (PGI-I) at Week 12 Endpoint

A scale that measures the patient's perception of urinary symptoms at endpoint compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).

Time frame:: 12 weeks
Reported as:: Number · participants

Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint
participants	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Very Much Worse	0	0	1
Much Worse	3	2	4
A Little Worse	12	3	13
No Change	34	34	61
A Little Better	66	79	63
Much Better	57	60	37
Very Much Better	13	19	6

Statistical analysis

Tadalafil 2.5 mg vs Placebo · Cochran-Mantel-Haenszel · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.)The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.
Tadalafil 5 mg vs Placebo · Cochran-Mantel-Haenszel · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.)The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.

SecondaryClinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint

A scale that measures clinician's rating of the total change in the patient's urinary symptoms at endpoint compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).

Time frame:: 12 weeks
Reported as:: Number · participants

Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint
participants	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Very Much Worse	0	0	1
Much Worse	2	1	4
A Little Worse	8	2	9
No Change	41	42	64
A Little Better	67	60	58
Much Better	56	78	45
Very Much Better	7	14	3

Statistical analysis

Tadalafil 2.5 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.006 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.)The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.
Tadalafil 5 mg vs Placebo · Cochran-Mantel-Haenszel · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.)The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.

SecondaryErectile Function General Assessment Questionnaire (EF-GAQ)

The EF-GAQ consisted of two questions: (1) Has the treatment you have been taking during this study improved your erections? and (2) If yes, has the treatment improved your ability to engage in sexual activity? Each question has a Yes/No response.

Time frame:: 12 weeks
Reported as:: Number · participants with yes response

Erectile Function General Assessment Questionnaire (EF-GAQ)
participants with yes response	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Question 1	135	155	74
Question 2	126	146	67

Statistical analysis

Tadalafil 2.5 mg vs Placebo · Regression, Logistic · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.)Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.
Tadalafil 2.5 mg vs Placebo · Regression, Logistic · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.)Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.
Tadalafil 5 mg vs Placebo · Regression, Logistic · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.)Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.
Tadalafil 5 mg · Regression, Logistic · p = <0.001 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.)Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.

SecondaryChange From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint

Qmax is 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.

Time frame:: Baseline, 12 weeks
Reported as:: Mean · mL/sec

Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint
mL/sec	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint	1.7 ± 4.45	1.6 ± 4.15	1.2 ± 4.52

Statistical analysis

Tadalafil 2.5 mg vs Placebo · Ranked ANOVA · p = 0.027 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.)
Tadalafil 5 mg vs Placebo · Ranked ANOVA · p = 0.186 (Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.)

SecondaryChange From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint

Qmean is defined as the average urine flow rate (measured in milliliters per second \[mL/second\] 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.

Time frame:: Baseline, 12 weeks
Reported as:: Mean · mL/sec

Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint
mL/sec	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint	1.0 ± 2.65	0.9 ± 2.92	0.6 ± 2.6

SecondaryChange From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint

Vcomp is defined as the volume of urine voided (measures in mL using a 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.

Time frame:: Baseline, 12 weeks
Reported as:: Mean · mL

Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint
mL	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint	18.5 ± 113.9	13.3 ± 92.75	11.4 ± 91.84

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Tadalafil 2.5 mg	—	2/198 (1%)	50/198 (25.3%)
Tadalafil 5 mg	—	1/208 (0.5%)	56/208 (26.9%)
Placebo	—	1/200 (0.5%)	38/200 (19%)

Most frequent serious events

Most frequent serious events
Event	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Myocardial infarctionCardiac disorders	1/198	0/208	0/200
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders	1/198	0/208	0/200
Non-Hodgkin's lymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/198	0/208	1/200
Pancreatitis haemorrhagicGastrointestinal disorders	0/198	1/208	0/200

Most frequent other events

Showing 10 of 124

Most frequent other events
Event	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
HeadacheNervous system disorders	5/198	12/208	6/200
NasopharyngitisInfections and infestations	6/198	5/208	4/200
Back painMusculoskeletal and connective tissue disorders	1/198	6/208	3/200
InfluenzaInfections and infestations	4/198	1/208	5/200
DyspepsiaGastrointestinal disorders	1/198	3/208	0/200
Upper respiratory tract infectionInfections and infestations	0/198	3/208	0/200
HypertensionVascular disorders	0/198	3/208	1/200
DiarrhoeaGastrointestinal disorders	2/198	1/208	1/200
BronchitisInfections and infestations	2/198	0/208	1/200
SinusitisInfections and infestations	2/198	1/208	2/200

Baseline characteristics

Age Continuous
Age Continuous(years)	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo	Total
Mean	62.2 ± 7.56	62.5 ± 8.43	62.9 ± 8.23	62.6 ± 8.08

Sex: Female, Male
Sex: Female, Male(Participants)	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo	Total
Female	0	0	0	0
Male	198	208	200	606

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo	Total
Hispanic or Latino	33	31	30	94
Not Hispanic or Latino	165	177	170	512
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo	Total
American Indian or Alaska Native	1	0	0	1
Asian	6	6	2	14
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	9	6	8	23
White	181	194	190	565
More than one race	1	2	0	3
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo	Total
France	17	24	21	62
Portugal	8	3	6	17
United States	71	71	68	210
Mexico	27	27	22	76
Canada	22	23	26	71
Greece	7	9	9	25
Russian Federation	21	29	25	75
Germany	10	12	9	31
Italy	15	10	14	39

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m²)	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo	Total
Mean	27.7 ± 3.86	28.0 ± 4.18	28.6 ± 4.8	28.1 ± 4.3

Lower Urinary Tract Symptoms (LUTS) Severity
Lower Urinary Tract Symptoms (LUTS) Severity(participants)	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo	Total
Moderate (IPSS <20)	123	124	122	369
Severe (IPSS ≥20)	74	84	78	236
Unknown	1	0	0	1

Peak Urine Flow Rate (Qmax)
Peak Urine Flow Rate (Qmax)(participants)	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo	Total
<10 mL/sec	96	87	99	282
10-15 mL/sec	73	83	66	222
>15mL/sec	21	16	16	53
Unknown	8	22	19	49

4 further baseline measures are reported on the registry.

Study locations

52 sites

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Anchorage, Alaska 99508, United States
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Phoenix, Arizona 85050, United States
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La Mesa, California 91942, United States
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Los Angeles, California 90017, United States
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Newport Beach, California 92660, United States
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San Diego, California 92120, United States
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Tarzana, California 91356, United States
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Englewood, Colorado 80113, United States
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Urbana, Illinois 61801, United States
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West Des Moines, Iowa 50266, United States
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Minneapolis, Minnesota 55455, United States
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Missoula, Montana 59802, United States
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Edmond, Oklahoma 73034, United States
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Dallas, Texas 75231, United States
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San Antonio, Texas 78229, United States
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Mountlake Terrace, Washington 98043, United States
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Spokane, Washington 99202, United States
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Surrey, British Columbia V3V 1N1, Canada
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Victoria, British Columbia V8V 3N1, Canada
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St. John, New Brunswick E2L 3J8, Canada
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Barrie, Ontario L4M 7G1, Canada
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Kitchener, Ontario N2N 3B9, Canada
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Carpentras, 84200, France
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Lyon, 69437, France
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Nice, 06002, France
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Nimes, 30029, France
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Orleans, 45067, France
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Toulouse, 31059, France
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Bad Rappenau, 74906, Germany
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Frankfurt, D-65933, Germany
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Holzminden, D-37603, Germany
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Kempen, 47906, Germany
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Athens, 11527, Greece
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Heraklion, 71110, Greece
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Larissa, 41221, Greece
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Patras, 26500, Greece
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Thessaloniki, 56429, Greece
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Genova, 16132, Italy
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Milan, 20132, Italy
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Sassari, 07100, Italy
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Trieste, 31149, Italy
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Colima, 28000, Mexico
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Durango, 34000, Mexico
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La Joya, 14000, Mexico
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Mexico City, 14050, Mexico
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Morelia, 58000, Mexico
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Amadora, 2700-351, Portugal
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Coimbra, 3000-075, Portugal
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Lisbon, 1250-203, Portugal
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Porto, 4202-451, Portugal
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Moscow, 119435, Russian Federation
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Rostov-On-Don, 344011, Russian Federation

References and documents

Publications

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. PubMed 26299520 ↗
Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2. PubMed 24119319 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00855582
Lead sponsor: Eli Lilly and Company
First posted: Mar 4, 2009
Start date: Mar 2009
Primary completion: Jul 2010
Completion: Jul 2010
Results posted: Jun 30, 2011
Last update: Jul 28, 2011

Study contacts

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study director · Eli Lilly and Company

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Data monitoring committee: No

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A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia

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