Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00631969
• Collaborator: GlaxoSmithKline (Industry), Schering-Plough (Industry)
• Enrollment: 362
• Locations: 47
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Vardenafil ODT (STAXYN, BAY38-9456); Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 362 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial - POTENT I
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Vardenafil ODT (STAXYN, BAY38-9456); Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)
Placebo Comparator: Placebo Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Drug: Placebo; Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF [from baseline up to 12 weeks]

   The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').

2. Change in Percentage From Baseline in Success of Penetration at 12 Weeks [from baseline up to 12 weeks of treatment]

   Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.

3. Change From Baseline in Success of Erection Maintenance at 12 Weeks [from baseline up to 12 weeks of treatment]

   SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.

Secondary Outcome Measures

1. Percentage of Subjects Achieving "Back to Normal" Erectile Function [up to 12 weeks of treatment]

   Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').

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

   SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.

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

   SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.

4. Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks [from baseline up to 12 weeks of treatment]

   SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.

5. Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks [from baseline up to 12 weeks of treatment]

   SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.

6. Number of Sexual Attempts Till First Successful Attempt [up to 12 weeks of treatment]

7. Change From Baseline in Ease With Erection at 12 Weeks or LOCF [from baseline up to 12 weeks]

   Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference.

8. Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF [from baseline up to 12 weeks]

   Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain " Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference.

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

   Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain " Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference.

10. Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF [from baseline up to 12 weeks]

    Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference.

11. Change From Baseline in Confidence for Completion at 12 Weeks or LOCF [from baseline up to 12 weeks]

    Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference.

12. Satisfaction With Medication at Week 12 or LOCF [up to 12 weeks]

    Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Satisfaction with medication" at LOCF expressed as the least square mean difference.

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

    Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)

14. Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma [Visit 5 after 12 weeks of treatment]

    Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

15. Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma [Visit 5 after 12 weeks of treatment]

    Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

16. Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma [Visit 5 after 12 weeks of treatment]

    Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

17. Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma [Visit 5 after 12 weeks of treatment]

    Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males 18 years-of-age or older

• Stable, heterosexual relationship for at least 6 months

• A history of erectile dysfunction (ED) for at least 6 months

Exclusion Criteria:

• Any underlying cardiovascular condition, including unstable angina pectoris

• History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1

• Uncontrolled atrial fibrillation / flutter at screening

• History of surgical prostatectomy for prostate cancer

• Hereditary degenerative retinal disorders

• History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision

• Presence of penile anatomical abnormalities

• Subjects who have been confirmed with phenylketonuria (PKU)

• Spinal cord injury

• Resting or postural hypotension or hypertension

• Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin

• Use of any treatment for ED within 7 days of Visit 1

• History of congenital QT prolongation

• History of syncope within the last 6 months prior to entry into the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Antwerpen		Belgium	2020
2		Bruxelles - Brussel		Belgium	1000
3		Bruxelles - Brussel		Belgium	1070
4		Bruxelles - Brussel		Belgium	1200
5		Genk		Belgium	3600
6		Gent		Belgium	9000
7		Liege		Belgium	4000
8		Lille		France	59000
9		Lyon Cedex		France	69437
10		Lyon		France	69000
11		Marseille		France	13006
12		Marseille		France	13009
13		Mont-de-marsan		France	40000
14		Paris		France	75008
15		München	Bayern	Germany	81925
16		Weiden	Bayern	Germany	92637
17		Osnabrück	Niedersachsen	Germany	49076
18		Mönchengladbach	Nordrhein-Westfalen	Germany	41063
19		Mülheim	Nordrhein-Westfalen	Germany	45468
20		Bautzen	Sachsen	Germany	02625
21		Leipzig	Sachsen	Germany	04109
22		Meißen	Sachsen	Germany	01662
23		Hamburg		Germany	20246
24		Hamburg		Germany	20354
25		Arnhem		Netherlands	6836 BH
26		Deurne		Netherlands	5751 XJ
27		Leiden		Netherlands	2316 ZL
28		Losser		Netherlands	7581 BV
29		Maastricht		Netherlands	6212 XN
30		Nijverdal		Netherlands	7442 LS
31		Centurion	Gauteng	South Africa	0140
32		Johannesburg	Gauteng	South Africa	1818
33		Johannesburg	Gauteng	South Africa	2198
34		Krugersdorp	Gauteng	South Africa	1739
35		Pretoria	Gauteng	South Africa	0001
36		Pretoria	Gauteng	South Africa	0083
37		Durban	KwaZulu Natal	South Africa	4037
38		Durban	KwaZulu Natal	South Africa	4091
39		Durban	Kwazulu-Natal	South Africa	4001
40		Cape Town	Western Cape	South Africa	7463
41		Cape Town	Western Cape	South Africa	7530
42		Alicante		Spain	03010
43		Barcelona		Spain	08003
44		Barcelona		Spain	08034
45		La Laguna		Spain	38320
46		Valencia		Spain	46010
47		Vigo		Spain	36211

Sponsors and Collaborators

• Bayer
• GlaxoSmithKline
• Schering-Plough

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here and search for information of Bayer products for Europe

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00631969
• Other Study ID Numbers: 12093; 2008-000536-40
• First Posted: Mar 10, 2008
• Last Update Posted: Dec 30, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Bayer: Erectile Dysfunction
• Additional relevant MeSH terms: Erectile Dysfunction; Vardenafil Dihydrochloride

Study Results

Participant Flow

Recruitment Details	Subjects recruited to 40 investigational centers in Belgium (4), France (8), Germany (9), Spain (3), Netherlands (5), and South Africa (11). First patient first visit on 25 April 2008, last patient last visit on 19 January 2009.
Pre-assignment Detail	409 male subjects screened (<65 years: n=185; >=65 years: n=224), 362 randomized to treatment (186 to Vardenafil ODT, and 176 to placebo). The main efficacy analysis set was the Intent-to-treat (ITT) population (randomized treated subjects with baseline and post-baseline efficacy and safety assessments); 183 on Vardenafil ODT and 172 on placebo.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Period Title: Overall Study
STARTED	186	176
Received Treatment	184	174
COMPLETED	171	155
NOT COMPLETED	15	21

Baseline Characteristics

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo	Total
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Total of all reporting groups
Overall Participants	184	174	358
Age, Customized (Number) [Number]
<65 years	87 47.3%	81 46.6%	168 46.9%
>=65 years	97 52.7%	93 53.4%	190 53.1%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	184 100%	174 100%	358 100%
Body Mass Index (BMI) (Kilograms per square meter (kg/m^2)) [Mean (Standard Deviation) ]
All age groups	27.2 (3.4)	27.5 (4.0)	27.3 (3.7)
< 65 years	27.5 (3.5)	27.9 (4.3)	27.7 (3.9)
>= 65 years	26.9 (3.2)	27.1 (3.6)	27.0 (3.4)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
Description	The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').
Time Frame	from baseline up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	183	172
<65 years	9.6 (6.28)	2.1 (7.33)
≥65 years	7.7 (8.19)	0.9 (6.42)
Total	8.6 (7.40)	1.4 (6.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.109
	Confidence Interval	() 95%; -8.562 to -5.6561
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Change in Percentage From Baseline in Success of Penetration at 12 Weeks
Description	Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.
Time Frame	from baseline up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	179	169
<65 years	35.8 (33.63)	5.5 (42.82)
≥65 years	35.2 (38.06)	8.7 (28.41)
Total	35.5 (35.93)	7.2 (35.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-29.027
	Confidence Interval	() 95%; -35.519 to -22.534
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Change From Baseline in Success of Erection Maintenance at 12 Weeks
Description	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.
Time Frame	from baseline up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	178	164
<65 years	54.5 (32.72)	15.2 (31.30)
≥65 years	49.2 (37.28)	7.7 (25.72)
Total	51.7 (35.18)	11.3 (28.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-38.193
	Confidence Interval	() 95%; -45.021 to -31.366
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Subjects Achieving "Back to Normal" Erectile Function
Description	Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').
Time Frame	up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	181	172
<65 years	46 25%	13 7.5%
≥65 years	34 18.5%	11 6.3%
Total	40 21.7%	12 6.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Cochran-Mantel-Haenszel (CMH) adjusted for age group and pooled center.
Method of Estimation	Estimation Parameter	Cochran-Mantel-Haenszel
	Estimated Value	34.778
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
Description	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.
Time Frame	from baseline up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	180	169
<65 years	18.8 (29.6)	-1.8 (37.86)
≥65 years	14.6 (33.21)	1.2 (37.43)
Total	16.6 (31.54)	-0.2 (37.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-16.503
	Confidence Interval	() 95%; -22.424 to -10.764
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
Description	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.
Time Frame	from baseline up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	179	164
<65 years	51.7 (36.10)	11.2 (27.69)
≥65 years	45.3 (43.09)	7.5 (27.70)
Total	48.4 (39.95)	9.2 (27.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-38.167
	Confidence Interval	() 95%; -45.261 to -31.073
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
Description	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.
Time Frame	from baseline up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	178	164
<65 years	55.7 (36.83)	14.4 (30.26)
≥65 years	45.8 (38.43)	5.6 (25.74)
Total	50.5 (37.90)	9.8 (28.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-36.555
	Confidence Interval	() 95%; -43.645 to -29.465
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
Description	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.
Time Frame	from baseline up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	179	163
<65 years	34.5 (36.19)	5.4 (36.86)
≥65 years	32.7 (35.23)	10.1 (29.96)
Total	33.5 (35.60)	7.9 (33.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-25.193
	Confidence Interval	() 95%; -31.562 to -18.824
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Number of Sexual Attempts Till First Successful Attempt
Time Frame	up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	180	169
<65 years	1.0 (2.6)	2.7 (4.4)
≥65 years	1.4 (3.1)	4.4 (7.4)
Total	1.2 (2.9)	3.6 (6.2)

10. Secondary Outcome

Title	Change From Baseline in Ease With Erection at 12 Weeks or LOCF
Description	Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Time Frame	from baseline up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	180	168
<65 years	28.6 (28.02)	4.2 (27.92)
≥65 years	25.0 (31.20)	0.8 (28.98)
Total	26.7 (29.73)	2.4 (28.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-24.703
	Confidence Interval	() 95%; -30.067 to -19.340
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
Description	Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain " Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Time Frame	from baseline up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	180	168
<65 years	1.3 (1.28)	0.1 (1.35)
≥65 years	1.2 (1.18)	-0.1 (1.28)
Total	1.3 (1.23)	0.0 (1.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-24.496
	Confidence Interval	() 95%; -34.865 to -24.128
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
Description	Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain " Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Time Frame	from baseline up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	180	168
<65 years	28.6 (29.34)	3.2 (29.06)
≥65 years	25.3 (30.24)	-3.6 (29.48)
Total	26.8 (29.78)	-0.4 (29.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-27.775
	Confidence Interval	() 95%; -33.155 to -22.394
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
Description	Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Time Frame	from baseline up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	180	168
<65 years	31.0 (29.46)	7.1 (32.66)
≥65 years	26.8 (32.29)	5.5 (31.80)
Total	28.8 (30.98)	6.3 (32.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-23.326
	Confidence Interval	() 95%; -29.062 to -17.598
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
Description	Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Time Frame	from baseline up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	180	168
<65 years	28.7 (27.56)	5.0 (27.53)
≥65 years	25.8 (30.18)	3.6 (26.57)
Total	27.7 (28.94)	4.2 (26.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-23.384
	Confidence Interval	() 95%; -28.594 to -18.175
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Satisfaction With Medication at Week 12 or LOCF
Description	Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Satisfaction with medication" at LOCF expressed as the least square mean difference.
Time Frame	up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	180	167
<65 years	57.2 (28.09)	22.1 (25.58)
≥65 years	52.3 (29.54)	20.4 (24.55)
Total	54.6 (28.90)	21.2 (24.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-33.076
	Confidence Interval	() 95%; -38.745 to -27.407
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
Description	Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)
Time Frame	up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	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.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	180	168
<65 years	76 41.3%	30 17.2%
≥65 years	69 37.5%	22 12.6%
Total	72 39.1%	26 14.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Cochran-Mantel-Haenszel (CMH) adjusted for pooled centers and age group.
Method of Estimation	Estimation Parameter	Cochran-Mantel-Haenszel
	Estimated Value	74.449
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma
Description	Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Time Frame	Visit 5 after 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

Pharmacokinetics (PK) were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. The PK data of one elderly patient were only evaluable for Cmax but not for AUC.

Arm/Group Title	ED Patients Aged < 65 Years	ED Patients Aged ≥ 65 Years
Arm/Group Description	Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.	Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
Measure Participants	12	12
Geometric Mean (Full Range) [μg*h/L]	47.16	55.37

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged < 65 years) were calculated.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Point estimate of ratio
	Estimated Value	117.42
	Confidence Interval	() 90%; 79.59 to 173.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.
Statistical Test of Hypothesis	p-Value	0.7064
	Comments
	Method	Regression, Linear
	Comments

18. Secondary Outcome

Title	Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma
Description	Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Time Frame	Visit 5 after 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.

Arm/Group Title	ED Patients Aged < 65 Years	ED Patients Aged ≥ 65 Years
Arm/Group Description	Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.	Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
Measure Participants	12	13
Geometric Mean (Full Range) [μg/L]	10.09	13.43

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged < 65 years) were calculated.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Point estimate of ratio
	Estimated Value	133.07
	Confidence Interval	() 90%; 87.46 to 202.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.
Statistical Test of Hypothesis	p-Value	0.8749
	Comments
	Method	Regression, Linear
	Comments

19. Secondary Outcome

Title	Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma
Description	Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Time Frame	Visit 5 after 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. AUC data were not available in 3 elderly patients.

Arm/Group Title	ED Patients Aged < 65 Years	ED Patients Aged ≥ 65 Years
Arm/Group Description	Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.	Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
Measure Participants	12	10
Geometric Mean (Full Range) [µg*h/L]	33.36	41.80

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years/ patients aged < 65 years) were calculated.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Point estimate of ratio
	Estimated Value	125.28
	Confidence Interval	() 90%; 73.65 to 213.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.
Statistical Test of Hypothesis	p-Value	0.7375
	Comments
	Method	Regression, Linear
	Comments

20. Secondary Outcome

Title	Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma
Description	Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Time Frame	Visit 5 after 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.

Arm/Group Title	ED Patients Aged < 65 Years	ED Patients Aged ≥ 65 Years
Arm/Group Description	Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.	Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
Measure Participants	12	13
Geometric Mean (Full Range) [µg/L]	9.260	11.47

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged < 65 years) were calculated.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Point estimate of ratio
	Estimated Value	123.84
	Confidence Interval	() 90%; 80.12 to 191.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.
Statistical Test of Hypothesis	p-Value	0.3940
	Comments
	Method	Regression, Linear
	Comments

Adverse Events

Arm/Group Title	Vardenafil ODT (STAXYN, BAY 38-9456)		Placebo
Arm/Group Description	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.		Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
All Cause Mortality
	Vardenafil ODT (STAXYN, BAY 38-9456)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Vardenafil ODT (STAXYN, BAY 38-9456)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/184 (2.2%)		1/174 (0.6%)
Cardiac disorders
Acute coronary syndrome	1/184 (0.5%)		0/174 (0%)
Ear and labyrinth disorders
Deafness neurosensory	0/184 (0%)		1/174 (0.6%)
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/184 (0.5%)		0/174 (0%)
Nervous system disorders
Syncope	1/184 (0.5%)		0/174 (0%)
Respiratory, thoracic and mediastinal disorders
Pneumothorax	1/184 (0.5%)		0/174 (0%)
Vascular disorders
Femoral arterial stenosis	1/184 (0.5%)		0/174 (0%)
Other (Not Including Serious) Adverse Events
	Vardenafil ODT (STAXYN, BAY 38-9456)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	70/184 (38%)		36/174 (20.7%)
Cardiac disorders
Angina pectoris	0/184 (0%)		1/174 (0.6%)
Bundle branch block left	1/184 (0.5%)		1/174 (0.6%)
Bundle branch block right	0/184 (0%)		3/174 (1.7%)
Mitral valve incompetence	0/184 (0%)		1/174 (0.6%)
Palpitations	1/184 (0.5%)		1/174 (0.6%)
Supraventricular extrasystoles	3/184 (1.6%)		2/174 (1.1%)
Tachycardia	0/184 (0%)		1/174 (0.6%)
Ventricular extrasystoles	1/184 (0.5%)		0/174 (0%)
Ear and labyrinth disorders
Vertigo	1/184 (0.5%)		0/174 (0%)
Eye disorders
Conjunctival haemorrhage	1/184 (0.5%)		0/174 (0%)
Eye disorder	1/184 (0.5%)		0/174 (0%)
Eye irritation	1/184 (0.5%)		0/174 (0%)
Ocular hyperaemia	1/184 (0.5%)		0/174 (0%)
Vision blurred	0/184 (0%)		1/174 (0.6%)
Gastrointestinal disorders
Colitis	1/184 (0.5%)		0/174 (0%)
Diarrhoea	3/184 (1.6%)		2/174 (1.1%)
Dyspepsia	7/184 (3.8%)		0/174 (0%)
Salivary gland calculus	1/184 (0.5%)		0/174 (0%)
General disorders
Asthenia	1/184 (0.5%)		0/174 (0%)
Chest pain	0/184 (0%)		1/174 (0.6%)
Fatigue	2/184 (1.1%)		0/174 (0%)
Feeling hot	2/184 (1.1%)		0/174 (0%)
Oedema	1/184 (0.5%)		0/174 (0%)
Pyrexia	1/184 (0.5%)		0/174 (0%)
Sluggishness	0/184 (0%)		1/174 (0.6%)
Induration	1/184 (0.5%)		0/174 (0%)
Hepatobiliary disorders
Cholelithiasis	1/184 (0.5%)		0/174 (0%)
Infections and infestations
Acute sinusitis	1/184 (0.5%)		0/174 (0%)
Bronchitis	0/184 (0%)		1/174 (0.6%)
Gastroenteritis	1/184 (0.5%)		0/174 (0%)
Herpes zoster	1/184 (0.5%)		0/174 (0%)
Influenza	1/184 (0.5%)		1/174 (0.6%)
Nasopharyngitis	2/184 (1.1%)		1/174 (0.6%)
Tooth abscess	0/184 (0%)		1/174 (0.6%)
Tooth infection	0/184 (0%)		1/174 (0.6%)
Injury, poisoning and procedural complications
Muscle injury	0/184 (0%)		1/174 (0.6%)
Excoriation	1/184 (0.5%)		0/174 (0%)
Muscle strain	1/184 (0.5%)		1/174 (0.6%)
Skeletal injury	1/184 (0.5%)		0/174 (0%)
Neck injury	1/184 (0.5%)		0/174 (0%)
Investigations
Alanine aminotransferase increased	1/184 (0.5%)		0/174 (0%)
Platelet count decreased	0/184 (0%)		1/174 (0.6%)
Platelet count increased	1/184 (0.5%)		0/174 (0%)
Metabolism and nutrition disorders
Gout	0/184 (0%)		1/174 (0.6%)
Hypercholesterolaemia	0/184 (0%)		1/174 (0.6%)
Musculoskeletal and connective tissue disorders
Back pain	3/184 (1.6%)		0/174 (0%)
Muscle spasms	2/184 (1.1%)		2/174 (1.1%)
Myalgia	2/184 (1.1%)		0/174 (0%)
Osteoarthritis	1/184 (0.5%)		0/174 (0%)
Pain in extremity	1/184 (0.5%)		0/174 (0%)
Intervertebral disc protrusion	1/184 (0.5%)		0/174 (0%)
Foot deformity	0/184 (0%)		1/174 (0.6%)
Nervous system disorders
Dizziness	3/184 (1.6%)		0/174 (0%)
Dysgeusia	4/184 (2.2%)		4/174 (2.3%)
Headache	30/184 (16.3%)		2/174 (1.1%)
Memory impairment	0/184 (0%)		1/174 (0.6%)
Paraesthesia	1/184 (0.5%)		0/174 (0%)
Tension headache	1/184 (0.5%)		0/174 (0%)
Psychiatric disorders
Libido decreased	0/184 (0%)		1/174 (0.6%)
Renal and urinary disorders
Haematuria	0/184 (0%)		1/174 (0.6%)
Polyuria	1/184 (0.5%)		0/174 (0%)
Reproductive system and breast disorders
Prostatitis	1/184 (0.5%)		0/174 (0%)
Respiratory, thoracic and mediastinal disorders
Dry throat	1/184 (0.5%)		1/174 (0.6%)
Dysphonia	0/184 (0%)		1/174 (0.6%)
Dyspnoea	0/184 (0%)		1/174 (0.6%)
Nasal congestion	3/184 (1.6%)		0/174 (0%)
Rhinorrhoea	0/184 (0%)		1/174 (0.6%)
Skin and subcutaneous tissue disorders
Erythema	1/184 (0.5%)		0/174 (0%)
Hyperhidrosis	0/184 (0%)		1/174 (0.6%)
Photosensitivity reaction	1/184 (0.5%)		0/174 (0%)
Pruritus	1/184 (0.5%)		0/174 (0%)
Rash	1/184 (0.5%)		0/174 (0%)
Social circumstances
Pharmaceutical product complaint	0/184 (0%)		3/174 (1.7%)
Surgical and medical procedures
Meniscus removal	0/184 (0%)		1/174 (0.6%)
Tooth extraction	0/184 (0%)		1/174 (0.6%)
Vascular disorders
Flushing	14/184 (7.6%)		0/174 (0%)
Hypertension	1/184 (0.5%)		1/174 (0.6%)
Orthostatic hypotension	2/184 (1.1%)		2/174 (1.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

In the protocol it is specified that all results are the property of the sponsor. The investigator must discuss any publication with the sponsor prior to release and obtain written consent of the sponsor. The investigator must send a draft publication to the sponsor thirty days in advance of submission in order to obtain approval prior to submission of the final version for publication.