Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Condition:	Impotence
Interventions:	Drug: tadalafil Drug: Placebo

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

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

	Placebo	Tadalafil
STARTED	78	264
COMPLETED	64	243
NOT COMPLETED	14	21
Physician Decision	1	1
Protocol Violation	1	6
Withdrawal by Subject	12	8
Adverse Event	0	3
Partner Decision	0	3

	Placebo	Tadalafil	Total
Number of Participants [units: participants]	78	264	342
Age [units: years] Mean ± Standard Deviation	53.82 ± 10.72	54.42 ± 10.04	54.29 ± 10.18
Gender [units: participants]
Female	0	0	0
Male	78	264	342
Region of Enrollment [units: participants]
France	11	41	52
United States	29	107	136
Mexico	19	63	82
Austria	8	17	25
Germany	11	36	47
Erectile Dysfunction History - Duration [units: participants]
>= 1 year	73	240	313
>= 3 months and < 6 months	1	8	9
>= 6 months and < 1 year	4	16	20
Erectile Dysfunction History - Etiology [units: participants]
Mixed	34	114	148
Organic	29	91	120
Psychogenic	12	30	42
Unknown	3	29	32
International Index of Erectile Function (IIEF) - Erectile Dysfunction Severity [units: participants]
Mild (17-30)	35	123	158
Moderate (11-16)	22	71	93
Severe (1-10)	20	63	83
Missing	1	7	8
Race/Ethnicity [units: participants]
African	0	6	6
Caucasian	57	188	245
Hispanic	21	69	90
Native American	0	1	1
International Index of Erectile Function (IIEF) - Erectile Function Domain^[1] [units: units on a scale] Mean ± Standard Deviation	15.27 ± 6.49	15.73 ± 6.13	15.62 ± 6.21

[1]	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.

Outcome Measures

1. Primary:

Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15) [ Baseline and 12 weeks ]

Measure Type	Primary
Measure Title	Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)
Measure Description	Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.
Time Frame	Baseline and 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.
last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	72	244
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15) [units: units on a scale] Least Squares Mean ± Standard Error	0.49 ± 0.781	8.03 ± 0.449

Statistical Analysis 1 for Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable

2. Primary:

Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) [ Baseline and 12 weeks ]

Measure Type	Primary
Measure Title	Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)
Measure Description	The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.
Time Frame	Baseline and 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.
last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	72	244
Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) [units: units on a scale] Least Squares Mean ± Standard Error
SQoL - Subject (change from baseline)	12.59 ± 2.866	39.37 ± 1.651
SQoL-Partner (change from baseline) (n=70, n=238)	7.93 ± 2.861	32.87 ± 1.638

Statistical Analysis 1 for Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 for Subject. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.

Statistical Analysis 2 for Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 for Partner. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.

3. Primary:

Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). [ Baseline and 12 weeks ]

Measure Type	Primary
Measure Title	Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).
Measure Description	The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.
Time Frame	Baseline and 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.
all randomized participants having both baseline and at least one post-baseline data measurement

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	74	251
Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). [units: percent] Least Squares Mean ± Standard Error
Question 2 change from baseline in percent "yes"	2.19 ± 2.833	28.80 ± 1.644
Question 3 change from baseline in percent "yes"	10.80 ± 3.767	46.46 ± 2.185

Statistical Analysis 1 for Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 for SEP Question 2. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.

Statistical Analysis 2 for Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 for SEP Question 3. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.

4. Secondary:

Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response [ Baseline and 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response
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 and 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.
last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	72	244
Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response [units: units on a scale] Least Squares Mean ± Standard Error	0.09 ± 0.356	2.74 ± 0.205

Statistical Analysis 1 for Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

5. Secondary:

Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response [ Baseline and 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response
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 and 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.
last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	72	244
Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response [units: units on a scale] Least Squares Mean ± Standard Error	0.44 ± 0.257	2.57 ± 0.148

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

6. Secondary:

Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain [ 12 weeks ]

Measure Type	Secondary
Measure Title	Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain
Measure Description	The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction).
Time Frame	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.
all randomized participants having post-baseline data measurement on this variable

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	72	244
Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain [units: units on a scale] Least Squares Mean ± Standard Error
SLQQ - Subject (n=72, n=244)	51.58 ± 2.246	75.04 ± 1.293
SLQQ - Partner (n=70, n=238)	55.25 ± 2.115	73.42 ± 1.214

Statistical Analysis 1 for Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10
[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 subject scores

Statistical Analysis 2 for Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10
[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 partner scores

7. Secondary:

Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response [ Baseline and 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response
Measure Description	The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.
Time Frame	Baseline and 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.
all randomized participants having both baseline and at least one post-baseline data measurement

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	74	251
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response [units: percent] Least Squares Mean ± Standard Error
Question 4 change from baseline in percent "Yes"	12.08 ± 3.936	50.05 ± 2.283
Question 5 change from baseline in percent "Yes"	11.47 ± 3.951	48.78 ± 2.292

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 for SEP Question 4

Statistical Analysis 2 for Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 for SEP Question 5

8. Secondary:

Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response [ Baseline and 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response
Measure Description	The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of “yes” responses to the question during the run-in period and postbaseline period, respectively.
Time Frame	Baseline and 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.
all randomized participants having both baseline and at least one post-baseline data measurement

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	73	250
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response [units: percent] Least Squares Mean ± Standard Error	10.21 ± 3.595	43.16 ± 2.072

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

9. Secondary:

Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response [ Baseline and 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response
Measure Description	The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction.
Time Frame	Baseline and 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.
last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	70	238
Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response [units: units on a scale] Least Squares Mean ± Standard Error	-0.40 ± 0.130	0.32 ± 0.075

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

10. Secondary:

Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response [ 12 weeks ]

Measure Type	Secondary
Measure Title	Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response
Measure Description	Percent of subjects with "Yes" responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)
Time Frame	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.
all randomized participants having post-baseline data measurement on this variable

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	72	244
Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response [units: percentage of subjects answering Yes]
GAQ Question 1	26	81
GAQ Question 2	22	79

Statistical Analysis 1 for Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response

Groups ^[1]	All groups
Method ^[2]	Regression, Logistic
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10
[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 GAQ Question 1

Statistical Analysis 2 for Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response

Groups ^[1]	All groups
Method ^[2]	Regression, Logistic
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10
[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 GAQ Question 2

11. Secondary:

Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response [ 12 weeks ]

Measure Type	Secondary
Measure Title	Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response
Measure Description	Percent of Partners with "Yes" responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)
Time Frame	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.
all randomized participants having post-baseline data measurement on this variable

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	70	238
Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response [units: percentage of partners answering Yes]
GAQ Question 1	30	79
GAQ Question 2	24	76

Statistical Analysis 1 for Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response

Groups ^[1]	All groups
Method ^[2]	Regression, Logistic
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10
[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 GAQ Question 1

Statistical Analysis 2 for Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response

Groups ^[1]	All groups
Method ^[2]	Regression, Logistic
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10
[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 GAQ Question 2

12. Secondary:

Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response [ Baseline and 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response
Measure Description	The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.
Time Frame	Baseline and 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.
all randomized participants having both baseline and at least one post-baseline data measurement

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	73	250
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response [units: percent] Least Squares Mean ± Standard Error
Question 1 change from baseline in percent "Yes"	1.25 ± 2.224	18.34 ± 1.270
Question 2 change from baseline in percent "Yes"	6.97 ± 2.896	30.69 ± 1.662

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 SEP Question 1

Statistical Analysis 2 for Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 SEP Question 2

13. Secondary:

Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire [ Baseline and 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire
Measure Description	Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1–8) and Confidence (items 9–14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.
Time Frame	Baseline and 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.
last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	72	244
Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire [units: units on a scale] Least Squares Mean ± Standard Error
Total Score change from baseline	3.07 ± 2.616	30.44 ± 1.506
Sexual Relationship change from baseline	4.61 ± 2.903	34.28 ± 1.673
Confidence change from baseline	0.91 ± 2.567	25.35 ± 1.475

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

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 SEAR Total Score

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

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 SEAR Sexual Relationship

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

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 SEAR Confidence

14. Secondary:

Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales [ Baseline and 12 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales
Measure Description	Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9–12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale.
Time Frame	Baseline and 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.
last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Measured Values

	Placebo	Tadalafil
Number of Participants Analyzed [units: participants]	72	244
Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales [units: units on a scale] Least Squares Mean ± Standard Error
Self-Esteem change from baseline	3.26 ± 2.743	29.56 ± 1.579
Overall Relationship change from baseline	-4.04 ± 2.792	16.97 ± 1.603

Statistical Analysis 1 for Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 SEAR Self-Esteem

Statistical Analysis 2 for Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
[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 SEAR Overall Relationship

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	9501, H6D-MC-LVGH
Study First Received:	January 16, 2007
Results First Received:	December 23, 2008
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00422734 History of Changes
Health Authority:	United States: Food and Drug Administration