A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once-Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia and Erectile Dysfunction

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01937871

Enrollment

909

Registered

2013-09-10

Start date

2013-09-30

Completion date

2015-12-31

Last updated

2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostate Hyperplasia, Erectile Dysfunction

Brief summary

The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract Symptoms (BPH-LUTS) and improve their quality of life.

Interventions

DRUG5 mg Tadalafil

Administered orally

DRUGPlacebo

Administered orally

DRUG0.2 mg Tamsulosin

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: * Present with a history of ED and signs and symptoms of BPH. * 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. Main

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 * Suffering from other urinary disease like cancer, or infection * Serious cardiovascular disease * History of significant renal insufficiency

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12	Baseline, Week 12	IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 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 mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment.The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.

Secondary

Measure	Time frame	Description
Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12	Baseline, Week 12	Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score was determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change is defined as the percentage of yes responses at endpoint minus the percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p \>= 0.10.
Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12	Baseline, Week 12	Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?.The SEP Q3 score is determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p \>= 0.10.
Change From Baseline in IPSS at Week 12	Baseline, Week 12	IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 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 mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.
Change From Baseline in Uroflowmetry Measures at Week 12	Baseline, Week 12	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 only if the prevoid total bladder volume (assessed by ultrasound) was \>=150 to \<=550 milliliters (mL) and the voided volume (Vcomp) was \>=125 mL. Changes in Qmax from baseline to endpoint in the double-blind treatment period were analyzed using Type III sums of squares ANOVA on rank-transformed data with a term for treatment group.
Change From Baseline in Postvoid Residual Volume (PVR) at Week 12	Baseline, Week 12	The amount of urine remaining in the bladder after void completion.
Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12	Baseline, Week 12	IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15; 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 mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.
Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12	Baseline, Week 12	IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20; 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 mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.
Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12	Baseline, Week 12	IPSS QoL assess participant response to the following question:If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options are Delighted(0),Pleased(1);Mostly satisfied(2);mixed about equally satisfied and dissatisfied(3);Mostly dissatisfied(4);Unhappy(5);Terrible(6),with a total ranging from 0 to 6; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares(LS) mean of change from baseline(bl) to endpoint is from MMRM.The model includes effects for treatment,country/region, prior alpha-blocker therapy,baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered bl value (defined as the bl value for a participant -the overall bl mean value),placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered bl-by-treatment and treatment-by-country/region interactions.
Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12	Week 12	PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).
Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12	Week 12	CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).
Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12	Baseline, Week 12	IIEF is a 15 item self-reported questionnaire to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0(low/no erectile function) to 5(high erectile function) and Question 15 is scored 1(very low confidence) to 5(very high confidence) with a total score ranging from 1 to 30.Higher scores represent better erectile function.LS mean of change from baseline to endpoint is from MMRM.The model includes effects for treatment,country/region,baseline lower urinary tract symptoms(LUTS) severity (moderate/severe),visit,treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant-the overall baseline mean value), placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered baseline-by-treatment and treatment-by-country/region interactions.The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.
Change From Baseline in IIEF Intercourse Satisfaction at Week 12	Baseline, Week 12	IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-IS is the sum of Questions 6,7 and 8 of the IIEF. Scores range from 0(low/no satisfaction) to 5(high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15.Higher scores were indicative of an increase in intercourse satisfaction. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant- the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.
Change From Baseline in IIEF Orgasmic Function at Week 12	Baseline, Week 12	IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF orgasmic function is the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher scores were indicative of better orgasmic function. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.
Change From Baseline in IIEF Sexual Desire at Week 12	Baseline, Week 12	IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF sexual desire is the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher scores were indicative of increased sexual desire. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.
Change From Baseline in IIEF Subscores at Week 12	Baseline, Week 12	IIEF Question 3 asks how often a participant 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). IIEF Question 4 asks whether/how often a participant 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 MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.
Change From Baseline in Total IPSS at Week 4 and Week 8	Baseline, Week 4; Baseline, Week 8	IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 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 mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.
Change From Baseline in IIEF EF at Week 4 and Week 8	Baseline, Week 4; Baseline, Week 8	IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 was scored 1 (very low confidence) to 5 (very high confidence) with a total score ranging from 1 to 30. Higher scores represent better erectile function. LS mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.
Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8	Baseline, Week 4; Baseline, Week 8	Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score is determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus the percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p \>= 0.10.
Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8	Baseline, Week 4; Baseline, Week 8	Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?. The SEP Q3 score is determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p \>= 0.10.
Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2	Baseline, Week 2	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, country/region, prior alpha-blocker use and baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p \>= 0.10.
Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12	Baseline, Week 12	IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with a total subscore ranging from 2 to 10;higher scores represent better erectile function. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.

Countries

China

Participant flow

Participants by arm

Arm	Count
Placebo Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.	361
5 mg Tadalafil Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.	363
0.2 mg Tamsulosin Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.	185
Total	909

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	6	6	2
Overall Study	Entry Criteria Not Met	1	2	1
Overall Study	Lost to Follow-up	8	2	4
Overall Study	Physician Decision	0	1	0
Overall Study	Withdrawal by Subject	9	6	4

Baseline characteristics

Characteristic	Placebo	5 mg Tadalafil	0.2 mg Tamsulosin	Total
Age, Continuous	61.8 years STANDARD_DEVIATION 7.35	61.8 years STANDARD_DEVIATION 7.27	61.9 years STANDARD_DEVIATION 7.06	61.8 years STANDARD_DEVIATION 7.25
Region of Enrollment China	279 Participants	277 Participants	143 Participants	699 Participants
Region of Enrollment Korea, Republic of	71 Participants	71 Participants	35 Participants	177 Participants
Region of Enrollment Taiwan	11 Participants	15 Participants	7 Participants	33 Participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	361 Participants	363 Participants	185 Participants	909 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	62 / 361	64 / 362	21 / 185
serious Total, serious adverse events	5 / 361	7 / 362	2 / 185

Outcome results

Primary

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12

IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 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 mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment.The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.

Time frame: Baseline, Week 12

Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12	-4.08 units on a scale	Standard Error 0.402
5 mg Tadalafil	Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12	-5.49 units on a scale	Standard Error 0.395
0.2 mg Tamsulosin	Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12	-4.92 units on a scale	Standard Error 0.493

95% CI: [-2.25, -0.57]

Secondary

Change From Baseline in IIEF EF at Week 4 and Week 8

IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 was scored 1 (very low confidence) to 5 (very high confidence) with a total score ranging from 1 to 30. Higher scores represent better erectile function. LS mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.

Time frame: Baseline, Week 4; Baseline, Week 8

Population: All randomized participants who had at least one dose of the study, had a baseline and at least one post-baseline IIEF measurement.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in IIEF EF at Week 4 and Week 8	Week 4	1.23 units on a scale	Standard Error 0.412
Placebo	Change From Baseline in IIEF EF at Week 4 and Week 8	Week 8	1.51 units on a scale	Standard Error 0.423
5 mg Tadalafil	Change From Baseline in IIEF EF at Week 4 and Week 8	Week 4	4.50 units on a scale	Standard Error 0.403
5 mg Tadalafil	Change From Baseline in IIEF EF at Week 4 and Week 8	Week 8	4.77 units on a scale	Standard Error 0.414
0.2 mg Tamsulosin	Change From Baseline in IIEF EF at Week 4 and Week 8	Week 4	1.43 units on a scale	Standard Error 0.498
0.2 mg Tamsulosin	Change From Baseline in IIEF EF at Week 4 and Week 8	Week 8	2.19 units on a scale	Standard Error 0.516

Secondary

Change From Baseline in IIEF Intercourse Satisfaction at Week 12

IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-IS is the sum of Questions 6,7 and 8 of the IIEF. Scores range from 0(low/no satisfaction) to 5(high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15.Higher scores were indicative of an increase in intercourse satisfaction. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant- the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.

Time frame: Baseline, Week 12