Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00836693

First received: February 2, 2009

Last updated: December 15, 2010

Last verified: December 2010

History of Changes

Results First Received: December 15, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Erectile Dysfunction
Interventions:	Drug: tadalafil Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Participant Flow: Overall Study

	Tadalafil	Placebo
STARTED	147	70
COMPLETED	130	64
NOT COMPLETED	17	6
Adverse Event	4	1
Sponsor Decision	0	1
Physician Decision	2	0
Withdrawal by Subject	9	4
Protocol Violation	1	0
Lost to Follow-up	1	0

Baseline Characteristics

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Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Total	Total of all reporting groups

Baseline Measures

	Tadalafil	Placebo	Total
Number of Participants [units: participants]	147	70	217
Age [units: years] Mean ± Standard Deviation	52.2 ± 10.90	51.9 ± 10.35	52.1 ± 10.71
Gender [units: participants]
Female	0	0	0
Male	147	70	217
Race/Ethnicity, Customized [units: participants]
White	144	69	213
Asian	2	0	2
Unknown	1	1	2
Region of Enrollment [units: participants]
Germany	39	19	58
Greece	19	9	28
Italy	27	13	40
Poland	31	14	45
Spain	31	15	46
Body Mass Index (BMI) [units: kilograms per square meter (kg/m²)] Mean ± Standard Deviation	27.92 ± 4.685	27.74 ± 3.423	27.86 ± 4.313

Outcome Measures

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1. Primary:

Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 [ Time Frame: Baseline, Week 12 ]

Measure Type	Primary
Measure Title	Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
Measure Description	Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.
Time Frame	Baseline, Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	67
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 [units: units on a scale] Mean ± Standard Deviation
Baseline	15.5 ± 6.00	16.0 ± 6.27
Week 12 Change	7.3 ± 6.01	3.3 ± 5.98

Statistical Analysis 1 for Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	3.9
Standard Error of the mean	± 0.85
95% Confidence Interval	( 2.2 to 5.5 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.
[4]	Other relevant estimation information:
	No text entered.

2. Primary:

Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses [ Time Frame: Baseline, Week 12 ]

Measure Type	Primary
Measure Title	Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Measure Description	Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per participant.
Time Frame	Baseline, Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	67
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses [units: percentage of yes responses] Mean ± Standard Deviation
Baseline	60.1 ± 38.77	59.9 ± 38.83
Week 12 Change	23.2 ± 31.92	11.6 ± 25.48

Statistical Analysis 1 for Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	11.7
Standard Error of the mean	± 3.35
95% Confidence Interval	( 5.1 to 18.3 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.
[4]	Other relevant estimation information:
	No text entered.

3. Primary:

Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses [ Time Frame: Baseline, 12 weeks ]

Measure Type	Primary
Measure Title	Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses
Measure Description	Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per participant.
Time Frame	Baseline, 12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	67
Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses [units: percentage of yes responses] Mean ± Standard Deviation
Baseline	28.2 ± 31.86	32.2 ± 35.93
Week 12 Change	39.4 ± 34.71	19.3 ± 36.18

Statistical Analysis 1 for Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	18.0
Standard Error of the mean	± 4.60
95% Confidence Interval	( 8.9 to 27.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.
[4]	Other relevant estimation information:
	No text entered.

4. Secondary:

Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night [ Time Frame: Baseline, Week 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night
Measure Description	NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up). Data are entered for the 2 nights prior to the visit. During the night the man may have multiple erections. The number of erections is recorded.
Time Frame	Baseline, Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night [units: Number of events per night] Mean ± Standard Deviation
Baseline (n=122, n=63)	2.75 ± 2.270	2.44 ± 2.002
Week 12 Change (n=96, n=49)	-0.11 ± 2.592	-0.09 ± 2.214

No statistical analysis provided for Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night

5. Secondary:

Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night [ Time Frame: Baseline, Week 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night
Measure Description	NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The duration of erections are measured and recorded. Data presented are the duration of erectile events at baseline and the change from baseline to Week 12.
Time Frame	Baseline, Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night [units: minutes] Mean ± Standard Deviation
Baseline (n=104, n=56)	28.487 ± 14.4791	26.372 ± 11.8969
Week 12 Change (n=65, n=33)	-1.553 ± 16.0073	-0.398 ± 12.4585

No statistical analysis provided for Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night

6. Secondary:

Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change [ Time Frame: Baseline, Week 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change
Measure Description	NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The percent of volume change of the penis during erections is measured and recorded for each erection. Data presented are mean percentage of volumetric change from baseline to Week 12.
Time Frame	Baseline, Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	65	33
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change [units: percent of volumetric change] Mean ± Standard Deviation	-5.96 ± 74.647	-50.30 ± 150.321

No statistical analysis provided for Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change

7. Secondary:

Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary [ Time Frame: Baseline, 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary
Measure Description	The morning erection diary allows the participant to record whether he experienced an erection on waking. The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods. The percentage of mornings the participant reported an erection is analysed.
Time Frame	Baseline, 12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary [units: percent] Mean ± Standard Deviation
Baseline (n=145, n=67)	31.0 ± 27.21	28.9 ± 25.74
Week 12 Change (n=145, n=66)	27.5 ± 25.29	11.9 ± 22.00

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	16.2
Standard Error of the mean	± 3.37
95% Confidence Interval	( 9.5 to 22.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The change from baseline to endpoint in morning erection percentages was analyzed with an ANCOVA model including terms for baseline value, treatment group, country, age and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value is for Week 12 change. For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

8. Secondary:

The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint [ Time Frame: Week 12 ]

Measure Type	Secondary
Measure Title	The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint
Measure Description	The subject questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction).
Time Frame	Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint [units: units on a scale] Mean ± Standard Deviation	72.8 ± 20.66	52.7 ± 22.62

Statistical Analysis 1 for The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	>0.001
Mean Difference (Final Values) ^[4]	20.0
Standard Error of the mean	± 3.11
95% Confidence Interval	( 13.9 to 26.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The models included terms for baseline value of the efficacy variable,treatment group,country, and the baseline-by-treatment-group interaction.In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

9. Secondary:

Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire [ Time Frame: Baseline, Week 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire
Measure Description	SEAR measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always. Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items. Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale.
Time Frame	Baseline, Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire [units: units on a scale] Mean ± Standard Deviation
Total (Baseline)	47.3 ± 21.95	47.9 ± 21.58
Total (Change)	20.4 ± 23.85	8.3 ± 21.14
Sexual Relationship Domain (Baseline)	43.0 ± 22.54	43.9 ± 21.68
Sexual Relationship Domain (Change)	23.4 ± 25.88	9.7 ± 22.35
Confidence Domain (Baseline)	53.1 ± 25.58	53.1 ± 24.85
Confidence Domain (Change)	16.5 ± 25.58	6.5 ± 24.57
Self-Esteem Domain (Baseline)	50.5 ± 28.15	48.5 ± 30.06
Self-Esteem Domain (Change)	19.2 ± 27.85	9.3 ± 30.05
Overall Relationship Domain (Baseline)	58.2 ± 31.47	62.3 ± 29.01
Overall Relationship Domain (Change)	11.0 ± 32.51	0.9 ± 30.17

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	11.7
Standard Error of the mean	± 3.17
95% Confidence Interval	( 5.5 to 18.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Total (Change). For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	13.2
Standard Error of the mean	± 3.36
95% Confidence Interval	( 6.6 to 19.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Sexual Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0034
Mean Difference (Final Values) ^[4]	9.9
Standard Error of the mean	± 3.34
95% Confidence Interval	( 3.3 to 16.5 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Confidence Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0020
Mean Difference (Final Values) ^[4]	11.0
Standard Error of the mean	± 3.52
95% Confidence Interval	( 4.1 to 17.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Self-Esteem Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0653
Mean Difference (Final Values) ^[4]	7.5
Standard Error of the mean	± 4.07
95% Confidence Interval	( -0.5 to 15.6 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Overall Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

10. Secondary:

Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) [ Time Frame: Baseline, Week 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)
Measure Description	Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.
Time Frame	Baseline, Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) [units: units on a scale] Mean ± Standard Deviation
Baseline	6.5 ± 2.99	7.2 ± 2.81
Week 12 Change	2.0 ± 2.78	0.5 ± 2.02

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	1.3
Standard Error of the mean	± 0.29
95% Confidence Interval	( 0.7 to 1.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

11. Secondary:

Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) [ Time Frame: Baseline, 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)
Measure Description	Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.
Time Frame	Baseline, 12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) [units: units on a scale] Mean ± Standard Deviation
Baseline	6.7 ± 1.81	6.6 ± 1.87
Week 12 Change	0.5 ± 1.93	-0.1 ± 1.78

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0089
Mean Difference (Final Values) ^[4]	0.7
Standard Error of the mean	± 0.25
95% Confidence Interval	( 0.2 to 1.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

12. Secondary:

Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) [ Time Frame: Baseline, Week 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)
Measure Description	Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.
Time Frame	Baseline, Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) [units: units on a scale] Mean ± Standard Deviation
Baseline	8.2 ± 2.65	7.6 ± 2.43
Week 12 Change	2.1 ± 2.67	1.5 ± 2.56

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0461
Mean Difference (Final Values) ^[4]	0.8
Standard Error of the mean	± 0.37
95% Confidence Interval	( 0.0 to 1.5 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

13. Secondary:

Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) [ Time Frame: Baseline, 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)
Measure Description	Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.
Time Frame	Baseline, 12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) [units: units on a scale] Mean ± Standard Deviation
Baseline	5.2 ± 2.15	5.1 ± 2.11
Week 12 Change	2.0 ± 2.37	0.8 ± 2.19

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	1.3
Standard Error of the mean	± 0.30
95% Confidence Interval	( 0.7 to 1.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

14. Secondary:

Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses [ Time Frame: Baseline, 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses
Measure Description	Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. "Were you able to achieve at least some erection (some enlargement of the penis)? " Data are presented as the mean percentage of yes responses per participant.
Time Frame	Baseline, 12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses [units: percentage of yes responses] Mean ± Standard Deviation
Baseline	80.8 ± 28.52	74.2 ± 34.26
Week 12 Change	12.5 ± 24.03	9.5 ± 24.67

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0047
Mean Difference (Final Values) ^[4]	6.3
Standard Error of the mean	± 2.22
95% Confidence Interval	( 2.0 to 10.7 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

15. Secondary:

Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses [ Time Frame: Baseline, 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses
Measure Description	Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of yes responses per participant.
Time Frame	Baseline, 12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses [units: percentage of yes responses] Mean ± Standard Deviation
Baseline	11.7 ± 21.16	14.6 ± 23.30
Week 12 Change	44.1 ± 35.75	18.3 ± 32.14

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	24.5
Standard Error of the mean	± 4.99
95% Confidence Interval	( 14.6 to 34.3 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

16. Secondary:

Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses [ Time Frame: Baseline, 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses
Measure Description	Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of yes responses per participant.
Time Frame	Baseline, 12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses [units: percentage of yes responses] Mean ± Standard Deviation
Baseline	10.3 ± 20.36	12.9 ± 22.11
Week 12 Change	43.2 ± 35.52	18.5 ± 30.98

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	23.5
Standard Error of the mean	± 4.96
95% Confidence Interval	( 13.7 to 33.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.
[4]	Other relevant estimation information:
	No text entered.

17. Secondary:

Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint [ Time Frame: Week 12 ]

Measure Type	Secondary
Measure Title	Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint
Measure Description	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 1=very much better to 7=very much worse.
Time Frame	Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint [units: participants]
Very Much Better	49	7
Much Better	41	8
Little Better	29	19
No Change	14	24
A Little Worse	5	5
Much Worse	4	3
Very Much Worse	2	1
Missing	4	2

Statistical Analysis 1 for Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint

Groups ^[1]	All groups
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Global Assessment Questions GAQ1. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

18. Secondary:

Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint [ Time Frame: Week 12 ]

Measure Type	Secondary
Measure Title	Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint
Measure Description	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 1=very much better to 7=very much worse.
Time Frame	Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.

Reporting Groups

	Description
Tadalafil	Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo	Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Measured Values

	Tadalafil	Placebo
Number of Participants Analyzed [units: participants]	146	69
Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint [units: participants]
Very Much Better	40	5
Much Better	49	11
Little Better	28	17
No Change	17	27
A Little Worse	3	4
Much Worse	4	3
Very Much Worse	1	0
Missing	4	2

Statistical Analysis 1 for Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint

Groups ^[1]	All groups
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value is for Global Assessment Question GAQ2.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Porst H, Brock GB, Kula K, Moncada I, Montorsi F, Basson BR, Kinchen K, Aversa A. Effects of once-daily tadalafil on treatment satisfaction, psychosocial outcomes, spontaneous erections, and measures of endothelial function in men with erectile dysfunction but naive to phosphodiesterase type 5 inhibitors. J Androl. 2012 Nov-Dec;33(6):1305-22. doi: 10.2164/jandrol.111.015289. Epub 2012 Jul 12.

Montorsi F, Aversa A, Moncada I, Perimenis P, Porst H, Barker C, Shane MA, Sorsaburu S. A randomized, double-blind, placebo-controlled, parallel study to assess the efficacy and safety of once-a-day tadalafil in men with erectile dysfunction who are naïve to PDE5 inhibitors. J Sex Med. 2011 Sep;8(9):2617-24. Epub 2011 Jun 27.

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00836693 History of Changes
Other Study ID Numbers:	12229, H6D-MC-LVHX
Study First Received:	February 2, 2009
Results First Received:	December 15, 2010
Last Updated:	December 15, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Italy: The Italian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Spanish Agency of Medicines

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