Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

Participant Flow:   Overall Study

	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

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.  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 ]

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 ]

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 ]

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 ]

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 ]

6.  Secondary:

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

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 ]

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 ]

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 ]

10.  Secondary:

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

11.  Secondary:

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

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 ]

13.  Secondary:

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

14.  Secondary:

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