Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited to 35 investigational centers in the USA (20), Canada (4), Mexico (5), and Australia (6). First patient first visit on 28 Apr 2008, last patient last visit on 13 Feb 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
473 subjects screened (<65 years: n=230; >=65 years: n=243), 339 randomized (Vardenafil 10 mg ODT=172, placebo=167). The main efficacy analysis set was the ITT (Intent to Treat) population (randomized treated sub. with baseline and post-baseline in any of the efficacy variables and safety assessment); Vardenafil 10 mg ODT=169, placebo=162

Reporting Groups

	Description
Vardenafil ODT (STAXYN, BAY38-9456)	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Placebo	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.

Participant Flow:   Overall Study

	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
STARTED	172	167
Safety Population	171 [1]	166 [1]
COMPLETED	151	144
NOT COMPLETED	21	23
Adverse Event	4	1
Lack of Efficacy	2	12
Lost to Follow-up	4	3
Protocol Violation	5	3
consent withdrawn	6	4

Reporting Groups

	Description
Vardenafil ODT (STAXYN, BAY38-9456)	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Placebo	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.

Baseline Measures

	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo	Total
Number of Participants   [units: participants]	171	166	337
Age, Customized   [units: participants]
<65 years	86	84	170
>=65 years	85	82	167
Gender   [units: participants]
Female	0	0	0
Male	171	166	337
Body Mass Index (BMI)   [units: Kilograms per square meter (kg/m^2)] Mean ± Standard Deviation	28.9  ± 4.4	28.7  ± 4.2	28.8  ± 4.3

1.  Primary:

Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)   [ Time Frame: from baseline up to 12 weeks ]

2.  Primary:

Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks   [ Time Frame: from baseline up to 12 weeks of treatment ]

3.  Primary:

Change From Baseline in Success of Erection Maintenance at 12 Weeks   [ Time Frame: from baseline up to 12 weeks of treatment ]

4.  Secondary:

Percentage of Subjects Achieving "Back to Normal" Erectile Function   [ Time Frame: up to 12 weeks of treatment ]

5.  Secondary:

Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks   [ Time Frame: from baseline up to 12 weeks of treatment ]

6.  Secondary:

Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks   [ Time Frame: from baseline up to 12 weeks of treatment ]

7.  Secondary:

Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks   [ Time Frame: from baseline up to 12 weeks of treatment ]

8.  Secondary:

Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks   [ Time Frame: from baseline up to 12 weeks of treatment ]

9.  Secondary:

Number of Sexual Attempts Till First Successful Attempt   [ Time Frame: up to 12 weeks of treatment ]

10.  Secondary:

Change From Baseline in Ease With Erection at 12 Weeks or LOCF   [ Time Frame: from baseline up to 12 weeks ]

11.  Secondary:

Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF   [ Time Frame: from baseline up to 12 weeks ]

12.  Secondary:

Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF   [ Time Frame: from baseline up to 12 weeks ]

13.  Secondary:

Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF   [ Time Frame: from baseline up to 12 weeks ]

14.  Secondary:

Change From Baseline in Confidence for Completion at 12 Weeks or LOCF   [ Time Frame: from baseline up to 12 weeks ]

15.  Secondary:

Satisfaction With Medication at Week 12 or LOCF   [ Time Frame: up to 12 weeks ]

16.  Secondary:

Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale   [ Time Frame: up to 12 weeks of treatment ]