A Study of Tadalafil After Radical Prostatectomy

A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01026818

Acronym

REACTT

Enrollment

583

Registered

2009-12-04

Start date

2009-11-30

Completion date

2012-10-31

Last updated

2014-01-14

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

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction, Radical Prostatectomy

Brief summary

The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day. Further objectives are to evaluate the treatment satisfaction of the respective therapies.

Interventions

DRUGTadalafil

Administered by mouth for 9 months

DRUGPlacebo

Administered by mouth, daily or on demand for 9 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 67 Years

Healthy volunteers

Inclusion criteria

* scheduled to undergo Bilateral nerve-sparing radical prostatectomy (BNSRP) for organ-confined, non-metastatic prostate cancer * have a normal preoperative erectile function score of more or equal to 22 at screening(as evaluated by International Index of Erectile Function - Erectile Function domain (IIEF-EF)) * develop Erectile Dysfunction (ED) (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) after surgery * have an interest in resuming sexual activity as soon as possible after surgery and anticipate having the same adult female sexual partner during the study * agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study * does not require the initiation of adjuvant therapy for prostate cancer

Exclusion criteria

* history of ED * have received previous or current treatment with tadalafil or any other Phosphodiesterase Type 5 (PDE5) inhibitor * have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer * have a history of prostatic surgery or prostatic physical treatments * have a history of diabetes mellitus * have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption * have clinically significant renal insufficiency as determined by the investigator

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire	Month 10.5	Self-reported erectile function 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 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.

Secondary

Measure	Time frame	Description
Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain	Month 9 and Month 13.5	Self-reported erectile function 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 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.
Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score	Randomization (Baseline), Months 9 and 10.5 and 13.5	Self-reported erectile function 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 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Randomization (Baseline), Months 9 and 10.5 and 13.5	Self-reported overall satisfaction during past 4 weeks. Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF. Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF. Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF. Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function. MMRM analysis was used to calculate LS mean and 95% CI. LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score	Months 9 and 13.5	The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment. Responses were based on the experiences during the previous 4 weeks. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered. The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction). The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).
Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Randomization (Baseline), Months 9 and 13.5	The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED). It consists of 14 items. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship. Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem). Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).
Global Assessment Questions (GAQ) Question 1 at Month 9	Month 9	GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).
Global Assessment Question (GAQ) Question 1 at Month 13.5	Month 13.5	GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).
Global Assessment Question (GAQ) Question 2 at Month 9	Month 9	GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).
Global Assessment Question (GAQ) Question 2 at Month 13.5	Month 13.5	GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).
Residual Erectile Function (REF) at Baseline	Baseline	The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
Residual Erectile Function (REF) at Month 2	Month 2	The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
Residual Erectile Function (REF) at Month 5	Month 5	The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
Residual Erectile Function (REF) at Month 9	Month 9	The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
Residual Erectile Function (REF) at Month 10.5	Month 10.5	The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
Residual Erectile Function (REF) at Month 13.5	Month 13.5	The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Randomization (Baseline), Months 9 and 10.5 and 13.5	Participant-assessed diary has 5 questions: Question (Q)1: erection achievement, Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).
Change From Baseline in 'Yes' Answers to Morning Erections	Randomization (Baseline), Month 10.5	The participants were asked to complete the morning erections diary every morning during the 4-week period before randomization and during the 6-week, Drug-Free, Washout Period. Data presented are the changes in the participant's percentage of yes responses relative to the number of days the question was answered during treatment. The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline morning erections frequency, age group and country.
Standardized Morning Erections Question (SMEQ) Score at Month 2	Month 2	Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).
Standardized Morning Erections Question (SMEQ) Score at Month 9	Month 9	Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).
Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Month 13.5	Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).
Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Randomization (Baseline), Months 9 and 13.5	EPIC-26 (participants) contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. Responses are based on experiences during the previous 4 weeks. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).
Change in Penile Length and Girth	Randomization (Baseline), Month 9	Measurements were performed with the penis in the flaccid state. The stretched penile length was measured from the tip of the glans to the pubopenile skin junction while applying tension to maximally stretch the penis. The penile circumference at midshaft was measured. All measurements were taken with a paper ruler to the nearest 0.5 centimeter (cm). The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline, age group and country.

Countries

Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom

Participant flow

Pre-assignment details

The study consisted of a 6-week screening period including the time of bilateral nerve-sparing radical prostatectomy (BNSRP) surgery, a 9-month, randomized Double-Blind (DB), Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label (OL) Period.

Participants by arm

Arm	Count
Tadalafil 5 mg OaD Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.	139
Tadalafil 20 mg PRN Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.	143
Placebo Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.	141
Total	423

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
DB Treatment Period (Month 0 - 9)	Adverse Event	0	10	6	4
DB Treatment Period (Month 0 - 9)	Entry Criteria Not Met	0	2	9	7
DB Treatment Period (Month 0 - 9)	Lack of Efficacy	0	3	2	6
DB Treatment Period (Month 0 - 9)	Lost to Follow-up	0	3	0	4
DB Treatment Period (Month 0 - 9)	Protocol Deviation	0	0	1	2
DB Treatment Period (Month 0 - 9)	Withdrawal by Subject	0	7	3	3
Drug-Free Washout Period (Month 9-10.5)	Adverse Event	0	1	0	0
Drug-Free Washout Period (Month 9-10.5)	Death	0	0	0	1
Drug-Free Washout Period (Month 9-10.5)	Entry Criteria Not Met	0	2	1	2
Drug-Free Washout Period (Month 9-10.5)	Lack of Efficacy	0	2	1	2
Drug-Free Washout Period (Month 9-10.5)	Lost to Follow-up	0	1	0	2
Drug-Free Washout Period (Month 9-10.5)	Physician Decision	0	1	1	0
Drug-Free Washout Period (Month 9-10.5)	Sponsor Decision	0	1	0	0
Drug-Free Washout Period (Month 9-10.5)	Withdrawal by Subject	0	1	2	0
OL Period (Month 10.5 - 13.5)	Entry Criteria Not Met	0	2	0	0
OL Period (Month 10.5 - 13.5)	Lack of Efficacy	0	1	0	0
OL Period (Month 10.5 - 13.5)	Lost to Follow-up	0	1	2	1
OL Period (Month 10.5 - 13.5)	Protocol Deviation	0	1	3	1
OL Period (Month 10.5 - 13.5)	Withdrawal by Subject	0	2	0	1
Screening Period	Adverse Event	2	0	0	0
Screening Period	Entry Criteria Not Met	105	0	0	0
Screening Period	Physician Decision	1	0	0	0
Screening Period	Protocol Deviation	3	0	0	0
Screening Period	Withdrawal by Subject	49	0	0	0

Baseline characteristics

Characteristic	Total	Placebo	Tadalafil 20 mg PRN	Tadalafil 5 mg OaD
Age, Continuous	57.9 years STANDARD_DEVIATION 5.58	57.6 years STANDARD_DEVIATION 5.69	57.5 years STANDARD_DEVIATION 5.91	58.6 years STANDARD_DEVIATION 5.07
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants	0 participants	1 participants	0 participants
Race/Ethnicity, Customized Asian	1 participants	1 participants	0 participants	0 participants
Race/Ethnicity, Customized Black or African American	5 participants	2 participants	1 participants	2 participants
Race/Ethnicity, Customized White	416 participants	138 participants	141 participants	137 participants
Region of Enrollment Belgium	24 participants	8 participants	9 participants	7 participants
Region of Enrollment Canada	38 participants	12 participants	13 participants	13 participants
Region of Enrollment France	38 participants	13 participants	13 participants	12 participants
Region of Enrollment Germany	78 participants	27 participants	25 participants	26 participants
Region of Enrollment Italy	73 participants	24 participants	24 participants	25 participants
Region of Enrollment Netherlands	3 participants	1 participants	2 participants	0 participants
Region of Enrollment Poland	27 participants	8 participants	9 participants	10 participants
Region of Enrollment Spain	116 participants	39 participants	39 participants	38 participants
Region of Enrollment Switzerland	3 participants	1 participants	1 participants	1 participants
Region of Enrollment United Kingdom	23 participants	8 participants	8 participants	7 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	423 Participants	141 Participants	143 Participants	139 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	114 / 583	50 / 139	52 / 143	40 / 141	11 / 139	18 / 143	9 / 141
serious Total, serious adverse events	6 / 583	2 / 139	3 / 143	10 / 141	1 / 139	1 / 143	2 / 141

Outcome results

Primary

Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire

Self-reported erectile function 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 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.

Time frame: Month 10.5

Population: All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurement at Month 10.5.

Arm	Measure	Value (NUMBER)
Tadalafil 5 mg OaD	Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire	20.9 percentage of participants
Tadalafil 20 mg PRN	Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire	16.9 percentage of participants
Placebo	Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire	19.1 percentage of participants

Comparison: A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.p-value: 0.67595% CI: [0.63, 2.06]Regression, Logistic

Secondary

Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score

EPIC-26 (participants) contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. Responses are based on experiences during the previous 4 weeks. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).

Time frame: Randomization (Baseline), Months 9 and 13.5

Population: All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline EPIC-26 scores measurement at Month 9 and Month 13.5.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
Tadalafil 5 mg OaD	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Urinary Incontinence - Month 9	34.08 units on a scale
Tadalafil 5 mg OaD	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Urinary Incontinence - Month 13.5	37.41 units on a scale
Tadalafil 5 mg OaD	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Urinary Irritative/Obstructive - Month 9	13.83 units on a scale
Tadalafil 5 mg OaD	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Urinary Irritative/Obstructive - Month 13.5	13.86 units on a scale
Tadalafil 5 mg OaD	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Bowel - Month 9	5.94 units on a scale
Tadalafil 5 mg OaD	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Bowel - Month 13.5	6.87 units on a scale
Tadalafil 5 mg OaD	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Sexual - Month 9	27.53 units on a scale
Tadalafil 5 mg OaD	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Sexual - Month 13.5	36.55 units on a scale
Tadalafil 5 mg OaD	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Hormonal - Month 9	1.72 units on a scale
Tadalafil 5 mg OaD	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Hormonal - Month 13.5	2.48 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Hormonal - Month 9	2.72 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Urinary Incontinence - Month 9	31.12 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Bowel - Month 13.5	6.49 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Bowel - Month 9	6.27 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Urinary Incontinence - Month 13.5	35.54 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Hormonal - Month 13.5	2.92 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Sexual - Month 13.5	32.58 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Urinary Irritative/Obstructive - Month 9	13.28 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Sexual - Month 9	20.66 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Urinary Irritative/Obstructive - Month 13.5	13.82 units on a scale
Placebo	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Sexual - Month 13.5	33.37 units on a scale
Placebo	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Urinary Irritative/Obstructive - Month 13.5	12.30 units on a scale
Placebo	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Bowel - Month 9	6.48 units on a scale
Placebo	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Bowel - Month 13.5	6.78 units on a scale
Placebo	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Hormonal - Month 9	-0.18 units on a scale
Placebo	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Sexual - Month 9	17.98 units on a scale
Placebo	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Urinary Incontinence - Month 9	30.59 units on a scale
Placebo	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Hormonal - Month 13.5	3.01 units on a scale
Placebo	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Urinary Incontinence - Month 13.5	35.44 units on a scale
Placebo	Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score	Urinary Irritative/Obstructive - Month 9	12.26 units on a scale

p-value: 0.19695% CI: [-1.82, 8.8]Mixed Models Analysis

p-value: 0.84195% CI: [-4.69, 5.75]Mixed Models Analysis

p-value: 0.47495% CI: [-3.45, 7.4]Mixed Models Analysis

p-value: 0.97195% CI: [-5.21, 5.41]Mixed Models Analysis

p-value: 0.23695% CI: [-1.03, 4.17]Mixed Models Analysis

p-value: 0.42995% CI: [-1.52, 3.56]Mixed Models Analysis

p-value: 0.25295% CI: [-1.12, 4.24]Mixed Models Analysis

p-value: 0.25195% CI: [-1.08, 4.11]Mixed Models Analysis

p-value: 0.67195% CI: [-3.03, 1.95]Mixed Models Analysis

p-value: 0.86895% CI: [-2.64, 2.23]Mixed Models Analysis

p-value: 0.93895% CI: [-2.37, 2.57]Mixed Models Analysis

p-value: 0.81395% CI: [-2.69, 2.12]Mixed Models Analysis

p-value: 0.00495% CI: [3.1, 15.99]Mixed Models Analysis

p-value: 0.40395% CI: [-3.63, 9]Mixed Models Analysis

p-value: 0.40695% CI: [-4.34, 10.69]Mixed Models Analysis

p-value: 0.83295% CI: [-8.11, 6.53]Mixed Models Analysis

p-value: 0.19795% CI: [-0.99, 4.79]Mixed Models Analysis

p-value: 0.04595% CI: [0.06, 5.72]Mixed Models Analysis

p-value: 0.69295% CI: [-3.16, 2.1]Mixed Models Analysis

p-value: 0.94395% CI: [-2.65, 2.46]Mixed Models Analysis

Secondary

Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score

The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED). It consists of 14 items. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship. Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem). Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).

Time frame: Randomization (Baseline), Months 9 and 13.5

Population: All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEAR scores measurement at Months 9 and 13.5.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
Tadalafil 5 mg OaD	Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Self-esteem - Month 9	0.78 units on a scale
Tadalafil 5 mg OaD	Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Self-esteem - Month 13.5	1.67 units on a scale
Tadalafil 5 mg OaD	Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Sexual relationship - Month 9	4.78 units on a scale
Tadalafil 5 mg OaD	Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Sexual relationship - Month 13.5	6.90 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Self-esteem - Month 9	0.79 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Sexual relationship - Month 13.5	6.68 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Self-esteem - Month 13.5	1.72 units on a scale
Tadalafil 20 mg PRN	Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Sexual relationship - Month 9	3.50 units on a scale
Placebo	Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Self-esteem - Month 13.5	1.62 units on a scale
Placebo	Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Sexual relationship - Month 9	3.02 units on a scale
Placebo	Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Sexual relationship - Month 13.5	6.72 units on a scale
Placebo	Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score	Self-esteem - Month 9	0.51 units on a scale

p-value: 0.08695% CI: [-0.25, 3.76]Mixed Models Analysis

p-value: 0.63795% CI: [-1.5, 2.45]Mixed Models Analysis

p-value: 0.88595% CI: [-2.18, 2.53]Mixed Models Analysis

p-value: 0.97295% CI: [-2.34, 2.25]Mixed Models Analysis

p-value: 0.62195% CI: [-0.81, 1.36]Mixed Models Analysis

p-value: 0.59895% CI: [-0.78, 1.35]Mixed Models Analysis

p-value: 0.92395% CI: [-1.1, 1.21]Mixed Models Analysis

p-value: 0.85795% CI: [-1.03, 1.24]Mixed Models Analysis

Secondary

Change From Baseline in 'Yes' Answers to Morning Erections

The participants were asked to complete the morning erections diary every morning during the 4-week period before randomization and during the 6-week, Drug-Free, Washout Period. Data presented are the changes in the participant's percentage of yes responses relative to the number of days the question was answered during treatment. The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline morning erections frequency, age group and country.

Time frame: Randomization (Baseline), Month 10.5

Population: All randomized participants who received at least 1 dose of study drug and had morning erection question answered at Baseline and Month 10.5.

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Morning Erections	8.92 percentage of yes response
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Morning Erections	12.16 percentage of yes response
Placebo	Change From Baseline in 'Yes' Answers to Morning Erections	14.04 percentage of yes response

p-value: 0.16295% CI: [-12.32, 2.08]ANCOVA

p-value: 0.60395% CI: [-8.99, 5.24]ANCOVA

Secondary

Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)

Participant-assessed diary has 5 questions: Question (Q)1: erection achievement, Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).

Time frame: Randomization (Baseline), Months 9 and 10.5 and 13.5

Population: All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEP questions answered at Months 9, 10.5 and 13.5.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q2 - Month 13.5	63.48 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q1 - Month 13.5	86.16 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q4 - Month 10.5	16.94 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q3 - Month 9	33.67 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q1 - Month 10.5	67.78 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q4 - Month 9	26.17 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q3 - Month 10.5	28.75 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q5 - Month 9	25.42 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q3 - Month 13.5	52.41 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q2 - Month 9	44.00 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q5 - Month 13.5	40.81 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q1 - Month 9	67.41 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q2 - Month 10.5	40.81 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q5 - Month 10.5	16.26 percentage of yes responses
Tadalafil 5 mg OaD	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q4 - Month 13.5	42.08 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q4 - Month 13.5	35.62 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q1 - Month 9	63.88 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q1 - Month 10.5	64.24 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q1 - Month 13.5	79.79 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q2 - Month 9	34.29 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q2 - Month 10.5	34.99 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q2 - Month 13.5	56.07 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q3 - Month 9	24.09 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q3 - Month 10.5	23.01 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q3 - Month 13.5	45.83 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q4 - Month 9	18.15 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q4 - Month 10.5	11.74 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q5 - Month 9	17.73 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q5 - Month 10.5	10.52 percentage of yes responses
Tadalafil 20 mg PRN	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q5 - Month 13.5	34.96 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q2 - Month 13.5	50.11 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q5 - Month 10.5	19.11 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q4 - Month 10.5	18.88 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q2 - Month 10.5	36.26 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q2 - Month 9	27.67 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q4 - Month 13.5	30.56 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q1 - Month 13.5	75.27 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q1 - Month 9	52.54 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q5 - Month 9	14.04 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q3 - Month 10.5	28.52 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q1 - Month 10.5	58.86 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q3 - Month 13.5	40.75 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q3 - Month 9	21.61 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q5 - Month 13.5	29.38 percentage of yes responses
Placebo	Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)	Q4 - Month 9	14.30 percentage of yes responses

p-value: 0.00895% CI: [3.92, 25.83]Mixed Models Analysis

p-value: 0.03895% CI: [0.63, 22.04]Mixed Models Analysis

p-value: 0.14895% CI: [-3.18, 21]Mixed Models Analysis

p-value: 0.37395% CI: [-6.48, 17.23]Mixed Models Analysis

p-value: 0.02995% CI: [1.14, 20.66]Mixed Models Analysis

p-value: 0.35795% CI: [-5.12, 14.17]Mixed Models Analysis

p-value: 0.00395% CI: [5.68, 26.98]Mixed Models Analysis

p-value: 0.21295% CI: [-3.8, 17.04]Mixed Models Analysis

p-value: 0.46195% CI: [-7.58, 16.68]Mixed Models Analysis

p-value: 0.83595% CI: [-13.16, 10.63]Mixed Models Analysis

p-value: 0.0395% CI: [1.27, 25.46]Mixed Models Analysis

p-value: 0.32695% CI: [-5.97, 17.89]Mixed Models Analysis

p-value: 0.01995% CI: [1.98, 22.15]Mixed Models Analysis

p-value: 0.62195% CI: [-7.38, 12.35]Mixed Models Analysis

p-value: 0.96895% CI: [-11.03, 11.49]Mixed Models Analysis

p-value: 0.32795% CI: [-16.55, 5.54]Mixed Models Analysis

p-value: 0.06695% CI: [-0.76, 24.09]Mixed Models Analysis

p-value: 0.41595% CI: [-7.17, 17.34]Mixed Models Analysis

p-value: 0.01195% CI: [2.79, 20.94]Mixed Models Analysis

p-value: 0.39495% CI: [-5.03, 12.72]Mixed Models Analysis

p-value: 0.68495% CI: [-11.28, 7.41]Mixed Models Analysis

p-value: 0.12695% CI: [-16.3, 2.02]Mixed Models Analysis

p-value: 0.06195% CI: [-0.53, 23.57]Mixed Models Analysis

p-value: 0.40395% CI: [-6.83, 16.95]Mixed Models Analysis

p-value: 0.01395% CI: [2.38, 20.38]Mixed Models Analysis

p-value: 0.4195% CI: [-5.11, 12.49]Mixed Models Analysis

p-value: 0.53795% CI: [-11.92, 6.22]Mixed Models Analysis

p-value: 0.05895% CI: [-17.48, 0.3]Mixed Models Analysis

p-value: 0.06195% CI: [-0.54, 23.41]Mixed Models Analysis

p-value: 0.35395% CI: [-6.23, 17.4]Mixed Models Analysis

Secondary

Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score

Self-reported erectile function 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 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).

Time frame: Randomization (Baseline), Months 9 and 10.5 and 13.5

Population: All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF-EF Total Scores measurement at Months 9, 10.5 and 13.5.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score	Month 10.5	6.24 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score	Month 9	7.73 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score	Month 13.5	10.60 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score	Month 10.5	5.76 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score	Month 9	6.53 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score	Month 13.5	9.78 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score	Month 9	4.93 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score	Month 13.5	8.97 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score	Month 10.5	5.98 units on a scale

p-value: 0.00795% CI: [0.76, 4.83]Mixed Models Analysis

p-value: 0.11895% CI: [-0.41, 3.6]Mixed Models Analysis

p-value: 0.80295% CI: [-1.79, 2.31]Mixed Models Analysis

p-value: 0.8395% CI: [-2.23, 1.79]Mixed Models Analysis

p-value: 0.18495% CI: [-0.78, 4.03]Mixed Models Analysis

p-value: 0.595% CI: [-1.54, 3.16]Mixed Models Analysis

Secondary

Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)

Self-reported overall satisfaction during past 4 weeks. Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF. Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF. Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF. Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function. MMRM analysis was used to calculate LS mean and 95% CI. LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).

Time frame: Randomization (Baseline), Months 9 and 10.5 and 13.5

Population: All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF domain scores measurements at Months 9, 10.5 and 13.5.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Orgasmic function - Month 9	2.76 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Orgasmic function - Month 10.5	2.94 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Orgasmic function - Month 13.5	3.57 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Sexual desire - Month 9	0.65 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Sexual desire - Month 10.5	0.61 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Sexual desire - Month 13.5	1.04 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Intercourse satisfaction - Month 9	3.89 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Intercourse satisfaction - Month 10.5	3.21 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Intercourse satisfaction - Month 13.5	4.70 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Overall satisfaction - Month 9	0.97 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Overall satisfaction - Month 10.5	0.64 units on a scale
Tadalafil 5 mg OaD	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Overall satisfaction - Month 13.5	1.50 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Overall satisfaction - Month 13.5	1.57 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Orgasmic function - Month 9	2.48 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Intercourse satisfaction - Month 9	3.50 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Intercourse satisfaction - Month 13.5	4.08 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Orgasmic function - Month 10.5	2.48 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Sexual desire - Month 13.5	0.89 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Overall satisfaction - Month 10.5	0.48 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Orgasmic function - Month 13.5	2.90 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Intercourse satisfaction - Month 10.5	2.81 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Sexual desire - Month 10.5	0.65 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Sexual desire - Month 9	0.65 units on a scale
Tadalafil 20 mg PRN	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Overall satisfaction - Month 9	0.93 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Sexual desire - Month 9	0.63 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Sexual desire - Month 10.5	0.55 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Overall satisfaction - Month 9	0.78 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Sexual desire - Month 13.5	0.95 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Intercourse satisfaction - Month 9	2.96 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Intercourse satisfaction - Month 10.5	2.72 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Overall satisfaction - Month 10.5	0.72 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Orgasmic function - Month 9	2.39 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Orgasmic function - Month 10.5	2.48 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Intercourse satisfaction - Month 13.5	4.14 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Orgasmic function - Month 13.5	3.42 units on a scale
Placebo	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)	Overall satisfaction - Month 13.5	1.52 units on a scale

p-value: 0.3495% CI: [-0.39, 1.14]Mixed Models Analysis

p-value: 0.82195% CI: [-0.67, 0.84]Mixed Models Analysis

p-value: 0.26895% CI: [-0.36, 1.28]Mixed Models Analysis

p-value: 0.99895% CI: [-0.8, 0.8]Mixed Models Analysis

p-value: 0.72895% CI: [-0.68, 0.97]Mixed Models Analysis

p-value: 0.20395% CI: [-1.33, 0.28]Mixed Models Analysis

p-value: 0.9595% CI: [-0.46, 0.49]Mixed Models Analysis

p-value: 0.9595% CI: [-0.45, 0.48]Mixed Models Analysis

p-value: 0.79295% CI: [-0.39, 0.51]Mixed Models Analysis

p-value: 0.63195% CI: [-0.34, 0.55]Mixed Models Analysis

p-value: 0.69195% CI: [-0.38, 0.58]Mixed Models Analysis

p-value: 0.80195% CI: [-0.53, 0.41]Mixed Models Analysis

p-value: 0.06595% CI: [-0.06, 1.92]Mixed Models Analysis

p-value: 0.27495% CI: [-0.43, 1.51]Mixed Models Analysis

p-value: 0.35995% CI: [-0.55, 1.52]Mixed Models Analysis

p-value: 0.86395% CI: [-0.93, 1.11]Mixed Models Analysis

p-value: 0.31495% CI: [-0.53, 1.66]Mixed Models Analysis

p-value: 0.9195% CI: [-1.13, 1.01]Mixed Models Analysis

p-value: 0.53295% CI: [-0.4, 0.78]Mixed Models Analysis

p-value: 0.6295% CI: [-0.43, 0.73]Mixed Models Analysis

p-value: 0.79295% CI: [-0.67, 0.51]Mixed Models Analysis

p-value: 0.4195% CI: [-0.82, 0.34]Mixed Models Analysis

p-value: 0.95595% CI: [-0.68, 0.65]Mixed Models Analysis

p-value: 0.86895% CI: [-0.59, 0.7]Mixed Models Analysis

Secondary

Change in Penile Length and Girth

Measurements were performed with the penis in the flaccid state. The stretched penile length was measured from the tip of the glans to the pubopenile skin junction while applying tension to maximally stretch the penis. The penile circumference at midshaft was measured. All measurements were taken with a paper ruler to the nearest 0.5 centimeter (cm). The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline, age group and country.

Time frame: Randomization (Baseline), Month 9

Population: All randomized participants who received at least 1 dose of study drug and had penile measurements at Baseline and Month 9.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
Tadalafil 5 mg OaD	Change in Penile Length and Girth	Length	-1.53 millimeter (mm)
Tadalafil 5 mg OaD	Change in Penile Length and Girth	Girth	0.03 millimeter (mm)
Tadalafil 20 mg PRN	Change in Penile Length and Girth	Length	-7.26 millimeter (mm)
Tadalafil 20 mg PRN	Change in Penile Length and Girth	Girth	0.82 millimeter (mm)
Placebo	Change in Penile Length and Girth	Length	-5.73 millimeter (mm)
Placebo	Change in Penile Length and Girth	Girth	-2.34 millimeter (mm)

p-value: 0.41395% CI: [-5.2, 2.14]ANCOVA

p-value: 0.11295% CI: [-0.55, 5.3]ANCOVA

p-value: 0.02895% CI: [0.47, 7.93]ANCOVA

p-value: 0.03195% CI: [0.29, 6.03]ANCOVA

Secondary

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score

The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment. Responses were based on the experiences during the previous 4 weeks. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered. The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction). The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).

Time frame: Months 9 and 13.5

Population: All randomized participants who received at least 1 dose of study drug and had EDITS mean scores measurements at Months 9 and 13.5.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Tadalafil 5 mg OaD	Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score	Month 9	2.21 units on a scale	95% Confidence Interval 0.11
Tadalafil 5 mg OaD	Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score	Month 13.5	2.54 units on a scale	—
Tadalafil 20 mg PRN	Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score	Month 9	2.11 units on a scale	—
Tadalafil 20 mg PRN	Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score	Month 13.5	2.38 units on a scale	—
Placebo	Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score	Month 9	1.88 units on a scale	—
Placebo	Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score	Month 13.5	2.25 units on a scale	—

p-value: 0.00595% CI: [0.1, 0.56]Mixed Models Analysis

p-value: 0.04195% CI: [0.01, 0.45]Mixed Models Analysis

p-value: 0.03595% CI: [0.02, 0.54]Mixed Models Analysis

p-value: 0.31695% CI: [-0.12, 0.38]Mixed Models Analysis

Secondary

Global Assessment Question (GAQ) Question 1 at Month 13.5

GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).

Time frame: Month 13.5

Population: All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 13.5.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 1 at Month 13.5	A little Better	28 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 1 at Month 13.5	Missing	4 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 1 at Month 13.5	A little worse	4 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 1 at Month 13.5	No Change	19 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 1 at Month 13.5	Very much worse	5 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 1 at Month 13.5	Much better	24 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 1 at Month 13.5	Very much better	13 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 1 at Month 13.5	Much worse	3 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 1 at Month 13.5	A little worse	4 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 1 at Month 13.5	Very much better	19 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 1 at Month 13.5	Much better	25 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 1 at Month 13.5	A little Better	27 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 1 at Month 13.5	No Change	23 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 1 at Month 13.5	Much worse	3 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 1 at Month 13.5	Very much worse	6 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 1 at Month 13.5	Missing	7 participants
Placebo	Global Assessment Question (GAQ) Question 1 at Month 13.5	A little worse	2 participants
Placebo	Global Assessment Question (GAQ) Question 1 at Month 13.5	Much worse	5 participants
Placebo	Global Assessment Question (GAQ) Question 1 at Month 13.5	Very much better	16 participants
Placebo	Global Assessment Question (GAQ) Question 1 at Month 13.5	Missing	5 participants
Placebo	Global Assessment Question (GAQ) Question 1 at Month 13.5	Very much worse	6 participants
Placebo	Global Assessment Question (GAQ) Question 1 at Month 13.5	No Change	26 participants
Placebo	Global Assessment Question (GAQ) Question 1 at Month 13.5	A little Better	28 participants
Placebo	Global Assessment Question (GAQ) Question 1 at Month 13.5	Much better	18 participants

Secondary

Global Assessment Question (GAQ) Question 2 at Month 13.5

GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).

Time frame: Month 13.5

Population: All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 13.5.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 13.5	Very much better	9 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 13.5	Much better	29 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 13.5	A little better	20 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 13.5	No change	25 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 13.5	A little worse	4 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 13.5	Much worse	4 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 13.5	Very much worse	5 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 13.5	Missing	4 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 13.5	A little better	26 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 13.5	Very much worse	6 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 13.5	No change	24 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 13.5	A little worse	5 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 13.5	Much worse	3 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 13.5	Very much better	20 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 13.5	Much better	23 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 13.5	Missing	7 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 13.5	A little better	24 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 13.5	Much better	21 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 13.5	Very much better	14 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 13.5	No change	26 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 13.5	Very much worse	4 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 13.5	Much worse	7 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 13.5	A little worse	5 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 13.5	Missing	5 participants

Secondary

Global Assessment Question (GAQ) Question 2 at Month 9

Time frame: Month 9

Population: All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 9.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 9	Very much better	7 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 9	Much better	12 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 9	A little better	30 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 9	No change	31 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 9	A little worse	8 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 9	Much worse	7 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 9	Very much worse	9 participants
Tadalafil 5 mg OaD	Global Assessment Question (GAQ) Question 2 at Month 9	Missing	10 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 9	A little better	26 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 9	Very much worse	9 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 9	No change	27 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 9	A little worse	10 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 9	Much worse	10 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 9	Very much better	7 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 9	Much better	25 participants
Tadalafil 20 mg PRN	Global Assessment Question (GAQ) Question 2 at Month 9	Missing	8 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 9	A little better	18 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 9	Much better	11 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 9	Very much better	3 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 9	No change	49 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 9	Very much worse	11 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 9	Much worse	10 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 9	A little worse	4 participants
Placebo	Global Assessment Question (GAQ) Question 2 at Month 9	Missing	9 participants

Secondary

Global Assessment Questions (GAQ) Question 1 at Month 9

Time frame: Month 9

Population: All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 9.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Global Assessment Questions (GAQ) Question 1 at Month 9	Very much better	9 participants
Tadalafil 5 mg OaD	Global Assessment Questions (GAQ) Question 1 at Month 9	Much better	12 participants
Tadalafil 5 mg OaD	Global Assessment Questions (GAQ) Question 1 at Month 9	A little better	33 participants
Tadalafil 5 mg OaD	Global Assessment Questions (GAQ) Question 1 at Month 9	No change	31 participants
Tadalafil 5 mg OaD	Global Assessment Questions (GAQ) Question 1 at Month 9	A little worse	4 participants
Tadalafil 5 mg OaD	Global Assessment Questions (GAQ) Question 1 at Month 9	Much worse	6 participants
Tadalafil 5 mg OaD	Global Assessment Questions (GAQ) Question 1 at Month 9	Very much worse	8 participants
Tadalafil 5 mg OaD	Global Assessment Questions (GAQ) Question 1 at Month 9	Missing	11 participants
Tadalafil 20 mg PRN	Global Assessment Questions (GAQ) Question 1 at Month 9	A little better	32 participants
Tadalafil 20 mg PRN	Global Assessment Questions (GAQ) Question 1 at Month 9	Very much worse	11 participants
Tadalafil 20 mg PRN	Global Assessment Questions (GAQ) Question 1 at Month 9	No change	28 participants
Tadalafil 20 mg PRN	Global Assessment Questions (GAQ) Question 1 at Month 9	A little worse	5 participants
Tadalafil 20 mg PRN	Global Assessment Questions (GAQ) Question 1 at Month 9	Much worse	8 participants
Tadalafil 20 mg PRN	Global Assessment Questions (GAQ) Question 1 at Month 9	Very much better	10 participants
Tadalafil 20 mg PRN	Global Assessment Questions (GAQ) Question 1 at Month 9	Much better	22 participants
Tadalafil 20 mg PRN	Global Assessment Questions (GAQ) Question 1 at Month 9	Missing	6 participants
Placebo	Global Assessment Questions (GAQ) Question 1 at Month 9	A little better	22 participants
Placebo	Global Assessment Questions (GAQ) Question 1 at Month 9	Much better	9 participants
Placebo	Global Assessment Questions (GAQ) Question 1 at Month 9	Very much better	4 participants
Placebo	Global Assessment Questions (GAQ) Question 1 at Month 9	No change	48 participants
Placebo	Global Assessment Questions (GAQ) Question 1 at Month 9	Very much worse	14 participants
Placebo	Global Assessment Questions (GAQ) Question 1 at Month 9	Much worse	6 participants
Placebo	Global Assessment Questions (GAQ) Question 1 at Month 9	A little worse	3 participants
Placebo	Global Assessment Questions (GAQ) Question 1 at Month 9	Missing	9 participants

Secondary

Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain

Time frame: Month 9 and Month 13.5

Population: All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurements at Months 9 and 13.5.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain	Month 9	25.2 percentage of participants
Tadalafil 5 mg OaD	Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain	Month 13.5	32.4 percentage of participants
Tadalafil 20 mg PRN	Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain	Month 9	19.7 percentage of participants
Tadalafil 20 mg PRN	Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain	Month 13.5	33.1 percentage of participants
Placebo	Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain	Month 9	14.2 percentage of participants
Placebo	Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain	Month 13.5	27.0 percentage of participants

p-value: 0.01695% CI: [1.16, 3.99]Regression, Logistic

p-value: 0.2195% CI: [0.79, 2.85]Regression, Logistic

p-value: 0.27395% CI: [0.79, 2.28]Regression, Logistic

p-value: 0.25995% CI: [0.8, 2.29]Regression, Logistic

Secondary

Residual Erectile Function (REF) at Baseline

The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)

Time frame: Baseline

Population: All randomized participants who received at least 1 dose of study drug and had REF assessed at baseline.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Baseline	REF = 0	61 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Baseline	REF = 1	46 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Baseline	REF = 2	18 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Baseline	REF = 3	12 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Baseline	REF = 4	0 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Baseline	Missing	2 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Baseline	Missing	2 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Baseline	REF = 0	62 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Baseline	REF = 3	11 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Baseline	REF = 4	2 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Baseline	REF = 1	48 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Baseline	REF = 2	17 participants
Placebo	Residual Erectile Function (REF) at Baseline	REF = 1	47 participants
Placebo	Residual Erectile Function (REF) at Baseline	REF = 2	17 participants
Placebo	Residual Erectile Function (REF) at Baseline	Missing	0 participants
Placebo	Residual Erectile Function (REF) at Baseline	REF = 3	13 participants
Placebo	Residual Erectile Function (REF) at Baseline	REF = 0	64 participants
Placebo	Residual Erectile Function (REF) at Baseline	REF = 4	0 participants

Secondary

Residual Erectile Function (REF) at Month 10.5

Time frame: Month 10.5

Population: All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 10.5.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 10.5	REF = 0	13 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 10.5	REF = 1	29 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 10.5	REF = 2	25 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 10.5	REF = 3	22 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 10.5	REF = 4	12 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 10.5	Missing	4 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 10.5	Missing	6 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 10.5	REF = 0	17 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 10.5	REF = 3	31 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 10.5	REF = 4	10 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 10.5	REF = 1	30 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 10.5	REF = 2	23 participants
Placebo	Residual Erectile Function (REF) at Month 10.5	REF = 1	29 participants
Placebo	Residual Erectile Function (REF) at Month 10.5	REF = 2	19 participants
Placebo	Residual Erectile Function (REF) at Month 10.5	Missing	2 participants
Placebo	Residual Erectile Function (REF) at Month 10.5	REF = 3	22 participants
Placebo	Residual Erectile Function (REF) at Month 10.5	REF = 0	22 participants
Placebo	Residual Erectile Function (REF) at Month 10.5	REF = 4	14 participants

Secondary

Residual Erectile Function (REF) at Month 13.5

Time frame: Month 13.5

Population: All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 13.5.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 13.5	REF = 4	21 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 13.5	Missing	4 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 13.5	REF = 2	17 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 13.5	REF = 0	5 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 13.5	REF = 3	34 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 13.5	REF = 1	19 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 13.5	REF = 0	8 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 13.5	REF = 4	28 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 13.5	REF = 1	20 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 13.5	REF = 2	20 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 13.5	Missing	4 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 13.5	REF = 3	34 participants
Placebo	Residual Erectile Function (REF) at Month 13.5	Missing	3 participants
Placebo	Residual Erectile Function (REF) at Month 13.5	REF = 0	11 participants
Placebo	Residual Erectile Function (REF) at Month 13.5	REF = 1	25 participants
Placebo	Residual Erectile Function (REF) at Month 13.5	REF = 2	15 participants
Placebo	Residual Erectile Function (REF) at Month 13.5	REF = 3	28 participants
Placebo	Residual Erectile Function (REF) at Month 13.5	REF = 4	24 participants

Secondary

Residual Erectile Function (REF) at Month 2

Time frame: Month 2

Population: All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 2.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 2	REF = 0	28 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 2	REF = 1	38 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 2	REF = 2	26 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 2	REF = 3	25 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 2	REF = 4	9 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 2	Missing	13 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 2	Missing	8 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 2	REF = 0	27 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 2	REF = 3	23 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 2	REF = 4	5 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 2	REF = 1	51 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 2	REF = 2	28 participants
Placebo	Residual Erectile Function (REF) at Month 2	REF = 1	53 participants
Placebo	Residual Erectile Function (REF) at Month 2	REF = 2	19 participants
Placebo	Residual Erectile Function (REF) at Month 2	Missing	11 participants
Placebo	Residual Erectile Function (REF) at Month 2	REF = 3	15 participants
Placebo	Residual Erectile Function (REF) at Month 2	REF = 0	38 participants
Placebo	Residual Erectile Function (REF) at Month 2	REF = 4	5 participants

Secondary

Residual Erectile Function (REF) at Month 5

Time frame: Month 5

Population: All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 5.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 5	REF = 0	12 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 5	REF = 1	37 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 5	Missing	8 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 5	REF = 2	19 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 5	REF = 3	32 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 5	REF = 4	15 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 5	REF = 3	34 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 5	REF = 4	6 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 5	REF = 2	21 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 5	REF = 0	21 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 5	Missing	7 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 5	REF = 1	39 participants
Placebo	Residual Erectile Function (REF) at Month 5	Missing	9 participants
Placebo	Residual Erectile Function (REF) at Month 5	REF = 0	27 participants
Placebo	Residual Erectile Function (REF) at Month 5	REF = 2	27 participants
Placebo	Residual Erectile Function (REF) at Month 5	REF = 3	19 participants
Placebo	Residual Erectile Function (REF) at Month 5	REF = 4	6 participants
Placebo	Residual Erectile Function (REF) at Month 5	REF = 1	35 participants

Secondary

Residual Erectile Function (REF) at Month 9

Time frame: Month 9

Population: All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 9.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 9	REF = 0	11 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 9	REF = 1	25 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 9	REF = 2	22 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 9	REF = 3	23 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 9	REF = 4	20 participants
Tadalafil 5 mg OaD	Residual Erectile Function (REF) at Month 9	Missing	13 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 9	Missing	5 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 9	REF = 0	17 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 9	REF = 3	27 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 9	REF = 4	15 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 9	REF = 1	28 participants
Tadalafil 20 mg PRN	Residual Erectile Function (REF) at Month 9	REF = 2	30 participants
Placebo	Residual Erectile Function (REF) at Month 9	REF = 1	35 participants
Placebo	Residual Erectile Function (REF) at Month 9	REF = 2	23 participants
Placebo	Residual Erectile Function (REF) at Month 9	Missing	6 participants
Placebo	Residual Erectile Function (REF) at Month 9	REF = 3	18 participants
Placebo	Residual Erectile Function (REF) at Month 9	REF = 0	23 participants
Placebo	Residual Erectile Function (REF) at Month 9	REF = 4	10 participants

Secondary

Standardized Morning Erections Question (SMEQ) Score at Month 13.5

Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).

Time frame: Month 13.5

Population: All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 13.5.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Less frequently than in the past	22 participants
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Never	32 participants
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Yes, regularly	13 participants
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Only occasionally	31 participants
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Missing	2 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Only occasionally	30 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Never	40 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Missing	5 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Less frequently than in the past	24 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Yes, regularly	15 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Missing	6 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Yes, regularly	13 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Less frequently than in the past	18 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Only occasionally	27 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 13.5	Never	42 participants

Secondary

Standardized Morning Erections Question (SMEQ) Score at Month 2

Time frame: Month 2

Population: All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 2

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 2	Never	73 participants
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 2	Only occasionally	41 participants
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 2	Yes, regularly	4 participants
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 2	Less frequently than in the past	8 participants
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 2	Missing	13 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 2	Only occasionally	31 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 2	Yes, regularly	7 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 2	Less frequently than in the past	15 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 2	Never	80 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 2	Missing	9 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 2	Missing	11 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 2	Never	87 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 2	Yes, regularly	7 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 2	Only occasionally	26 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 2	Less frequently than in the past	10 participants

Secondary

Standardized Morning Erections Question (SMEQ) Score at Month 9

Time frame: Month 9

Population: All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 9.

Arm	Measure	Group	Value (NUMBER)
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 9	Never	39 participants
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 9	Only occasionally	36 participants
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 9	Yes, regularly	7 participants
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 9	Less frequently than in the past	21 participants
Tadalafil 5 mg OaD	Standardized Morning Erections Question (SMEQ) Score at Month 9	Missing	11 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 9	Only occasionally	26 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 9	Yes, regularly	9 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 9	Less frequently than in the past	19 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 9	Never	61 participants
Tadalafil 20 mg PRN	Standardized Morning Erections Question (SMEQ) Score at Month 9	Missing	7 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 9	Missing	7 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 9	Never	65 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 9	Yes, regularly	7 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 9	Only occasionally	27 participants
Placebo	Standardized Morning Erections Question (SMEQ) Score at Month 9	Less frequently than in the past	9 participants

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026

A Study of Tadalafil After Radical Prostatectomy

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Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire

Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score

Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score

Change From Baseline in 'Yes' Answers to Morning Erections

Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)

Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score

Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)

Change in Penile Length and Girth

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score

Global Assessment Question (GAQ) Question 1 at Month 13.5

Global Assessment Question (GAQ) Question 2 at Month 13.5

Global Assessment Question (GAQ) Question 2 at Month 9

Global Assessment Questions (GAQ) Question 1 at Month 9

Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain

Residual Erectile Function (REF) at Baseline

Residual Erectile Function (REF) at Month 10.5

Residual Erectile Function (REF) at Month 13.5

Residual Erectile Function (REF) at Month 2

Residual Erectile Function (REF) at Month 5

Residual Erectile Function (REF) at Month 9

Standardized Morning Erections Question (SMEQ) Score at Month 13.5

Standardized Morning Erections Question (SMEQ) Score at Month 2

Standardized Morning Erections Question (SMEQ) Score at Month 9