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

	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

Baseline Characteristics

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

Baseline Measures

	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

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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 ]

Show Outcome Measure 1

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 ]

Hide Outcome Measure 2

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 ]

Show Outcome Measure 3

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 ]

Show Outcome Measure 4

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 ]

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

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 ]

Show Outcome Measure 7

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 ]

Show Outcome Measure 8

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 ]

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

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 ]

Show Outcome Measure 12

13. Secondary:

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

Show Outcome Measure 13

14. Secondary:

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

Show Outcome Measure 14

Serious Adverse Events

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Other Adverse Events

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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
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979

No publications provided

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