Trial Outcomes & Findings for Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older. (NCT NCT00655629)

Last Updated: 2014-08-01

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

339 participants

Primary outcome timeframe

from baseline up to 12 weeks

Results posted on

2014-08-01

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	172	167
Overall Study Participants Received Treatment	171	166
Overall Study COMPLETED	151	144
Overall Study NOT COMPLETED	21	23

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	4	1
Overall Study Lack of Efficacy	2	12
Overall Study Lost to Follow-up	4	3
Overall Study Protocol Violation	5	3
Overall Study consent withdrawn	6	4

Baseline Characteristics

Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=171 Participants 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 n=166 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Total n=337 Participants Total of all reporting groups
Age, Customized <65 years	86 participants n=5 Participants	84 participants n=7 Participants	170 participants n=5 Participants
Age, Customized >=65 years	85 participants n=5 Participants	82 participants n=7 Participants	167 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	171 Participants n=5 Participants	166 Participants n=7 Participants	337 Participants n=5 Participants
Body Mass Index (BMI)	28.9 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.4 • n=5 Participants	28.7 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.2 • n=7 Participants	28.8 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.3 • n=5 Participants

PRIMARY outcome

Timeframe: from baseline up to 12 weeks

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

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=167 Participants 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 n=160 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) <65 years	10.3 scores on a scale Standard Deviation 7.78	1.7 scores on a scale Standard Deviation 6.28
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) >=65 years	6.7 scores on a scale Standard Deviation 8.06	1.1 scores on a scale Standard Deviation 6.01
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) Total	8.5 scores on a scale Standard Deviation 8.11	1.4 scores on a scale Standard Deviation 6.14

PRIMARY outcome

Timeframe: from baseline up to 12 weeks of treatment

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

SEP (Sexual Encounter Profile) 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.

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=168 Participants 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 n=161 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks <65 years	33.2 percentage of successful penetrations Standard Deviation 33.27	4.6 percentage of successful penetrations Standard Deviation 34.12
Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks >=65 years	27.3 percentage of successful penetrations Standard Deviation 37.39	3.0 percentage of successful penetrations Standard Deviation 33.33
Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks Total	30.2 percentage of successful penetrations Standard Deviation 35.40	3.8 percentage of successful penetrations Standard Deviation 33.63

PRIMARY outcome

Timeframe: from baseline up to 12 weeks of treatment

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

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.

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=168 Participants 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 n=160 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Change From Baseline in Success of Erection Maintenance at 12 Weeks <65 years	53.2 percentage of successful maintenance Standard Deviation 33.22	15.2 percentage of successful maintenance Standard Deviation 29.55
Change From Baseline in Success of Erection Maintenance at 12 Weeks >=65 years	38.8 percentage of successful maintenance Standard Deviation 38.32	8.7 percentage of successful maintenance Standard Deviation 29.15
Change From Baseline in Success of Erection Maintenance at 12 Weeks Total	46.0 percentage of successful maintenance Standard Deviation 36.47	12.0 percentage of successful maintenance Standard Deviation 29.44

SECONDARY outcome

Timeframe: up to 12 weeks of treatment

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

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').

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=167 Participants 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 n=160 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Percentage of Subjects Achieving "Back to Normal" Erectile Function <65 years	59 percentage of subjects	11 percentage of subjects
Percentage of Subjects Achieving "Back to Normal" Erectile Function >=65 years	32 percentage of subjects	8 percentage of subjects
Percentage of Subjects Achieving "Back to Normal" Erectile Function Total	46 percentage of subjects	9 percentage of subjects

SECONDARY outcome

Timeframe: from baseline up to 12 weeks of treatment

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

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=168 Participants 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 n=161 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks <65 years	13.4 percentage of successful erections Standard Deviation 28.63	-5.8 percentage of successful erections Standard Deviation 38.18
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks >=65 years	9.6 percentage of successful erections Standard Deviation 35.96	-3.8 percentage of successful erections Standard Deviation 37.04
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks Total	11.5 percentage of successful erections Standard Deviation 32.46	-4.8 percentage of successful erections Standard Deviation 37.51

SECONDARY outcome

Timeframe: from baseline up to 12 weeks of treatment

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

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=168 Participants 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 n=160 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks <65 years	52.0 percentage of satisfactory erections Standard Deviation 40.04	12.2 percentage of satisfactory erections Standard Deviation 30.89
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks >=65 years	36.1 percentage of satisfactory erections Standard Deviation 41.54	5.4 percentage of satisfactory erections Standard Deviation 31.21
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks Total	44.1 percentage of satisfactory erections Standard Deviation 41.45	8.8 percentage of satisfactory erections Standard Deviation 31.14

SECONDARY outcome

Timeframe: from baseline up to 12 weeks of treatment

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

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.

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=168 Participants 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 n=160 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks <65 years	52.0 percentage of satisfactory attempts Standard Deviation 40.04	12.2 percentage of satisfactory attempts Standard Deviation 30.89
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks >=65 years	38.4 percentage of satisfactory attempts Standard Deviation 38.43	10.3 percentage of satisfactory attempts Standard Deviation 26.70
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks Total	45.1 percentage of satisfactory attempts Standard Deviation 40.15	11.2 percentage of satisfactory attempts Standard Deviation 26.39

SECONDARY outcome

Timeframe: from baseline up to 12 weeks of treatment

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

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=168 Participants 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 n=160 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks <65 years	37.3 percentage of ejaculation successes Standard Deviation 32.52	7.1 percentage of ejaculation successes Standard Deviation 35.0
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks >=65 years	17.7 percentage of ejaculation successes Standard Deviation 36.27	2.7 percentage of ejaculation successes Standard Deviation 36.51
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks Total	27.5 percentage of ejaculation successes Standard Deviation 35.72	4.9 percentage of ejaculation successes Standard Deviation 35.71

SECONDARY outcome

Timeframe: up to 12 weeks of treatment

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

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=134 Participants 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 n=92 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Number of Sexual Attempts Till First Successful Attempt <65 years	1.2 Sexual Attempts Standard Deviation 3.7	2.6 Sexual Attempts Standard Deviation 3.5
Number of Sexual Attempts Till First Successful Attempt >=65 years	1.6 Sexual Attempts Standard Deviation 4.5	3.8 Sexual Attempts Standard Deviation 3.9
Number of Sexual Attempts Till First Successful Attempt Total	1.4 Sexual Attempts Standard Deviation 4.1	3.1 Sexual Attempts Standard Deviation 3.7

SECONDARY outcome

Timeframe: from baseline up to 12 weeks

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

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

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=158 Participants 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 n=158 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Change From Baseline in Ease With Erection at 12 Weeks or LOCF <65 years	24.0 scores on a scale Standard Deviation 34.29	6.1 scores on a scale Standard Deviation 31.77
Change From Baseline in Ease With Erection at 12 Weeks or LOCF >=65 years	14.4 scores on a scale Standard Deviation 29.17	0.0 scores on a scale Standard Deviation 27.84
Change From Baseline in Ease With Erection at 12 Weeks or LOCF Total	19.1 scores on a scale Standard Deviation 32.07	3.0 scores on a scale Standard Deviation 29.91

SECONDARY outcome

Timeframe: from baseline up to 12 weeks

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

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

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=158 Participants 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 n=158 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF <65 years	41.2 scores on a scale Standard Deviation 27.78	7.6 scores on a scale Standard Deviation 24.95
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF >=65 years	25.4 scores on a scale Standard Deviation 26.11	4.2 scores on a scale Standard Deviation 24.84
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF Total	33.2 scores on a scale Standard Deviation 28.01	5.9 scores on a scale Standard Deviation 24.88

SECONDARY outcome

Timeframe: from baseline up to 12 weeks

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

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

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=158 Participants 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 n=158 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF <65 years	30.1 scores on a scale Standard Deviation 24.63	4.8 scores on a scale Standard Deviation 25.82
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF >=65 years	15.3 scores on a scale Standard Deviation 29.63	-1.9 scores on a scale Standard Deviation 22.42
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF Total	22.6 scores on a scale Standard Deviation 28.19	1.4 scores on a scale Standard Deviation 24.31

SECONDARY outcome

Timeframe: from baseline up to 12 weeks

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

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

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=158 Participants 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 n=157 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF	23.6 scores on a scale Standard Deviation 30.81	3.2 scores on a scale Standard Deviation 31.36

SECONDARY outcome

Timeframe: from baseline up to 12 weeks

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

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

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=158 Participants 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 n=158 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF <65 years	38.0 scores on a scale Standard Deviation 28.59	4.8 scores on a scale Standard Deviation 28.22
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF >=65 years	20.2 scores on a scale Standard Deviation 27.74	2.8 scores on a scale Standard Deviation 27.05
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF Total	29.0 scores on a scale Standard Deviation 29.46	3.8 scores on a scale Standard Deviation 27.56

SECONDARY outcome

Timeframe: up to 12 weeks

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

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

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=159 Participants 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 n=158 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Satisfaction With Medication at Week 12 or LOCF <65 years	58.6 scores on a scale Standard Deviation 26.55	19.3 scores on a scale Standard Deviation 26.55
Satisfaction With Medication at Week 12 or LOCF >=65 years	42.5 scores on a scale Standard Deviation 30.26	20.2 scores on a scale Standard Deviation 24.59
Satisfaction With Medication at Week 12 or LOCF Total	50.5 scores on a scale Standard Deviation 29.52	19.7 scores on a scale Standard Deviation 25.50

SECONDARY outcome

Timeframe: up to 12 weeks of treatment

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

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)

Outcome measures

Outcome measures
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=160 Participants 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 n=157 Participants Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale <65 years	75 percentage of participants	19 percentage of participants
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale >=65 years	59 percentage of participants	28 percentage of participants
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale Total	67 percentage of participants	24 percentage of participants

Adverse Events

Vardenafil ODT (STAXYN, BAY38-9456)

Serious events: 2 serious events

Other events: 65 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=171 participants at risk 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 n=166 participants at risk Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Cardiac disorders Arrhythmia	0.58% 1/171	0.00% 0/166
General disorders Chest pain	0.58% 1/171	0.00% 0/166
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/171	0.60% 1/166
Vascular disorders Hypertension	0.58% 1/171	0.00% 0/166

Other adverse events

Other adverse events
Measure	Vardenafil ODT (STAXYN, BAY38-9456) n=171 participants at risk 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 n=166 participants at risk Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/171	0.60% 1/166
Skin and subcutaneous tissue disorders Night sweats	0.58% 1/171	0.00% 0/166
Skin and subcutaneous tissue disorders Rash	1.2% 2/171	1.2% 2/166
Social circumstances Pharmaceutical product complaint	0.00% 0/171	0.60% 1/166
Surgical and medical procedures Skin lesion excision	0.00% 0/171	0.60% 1/166
Surgical and medical procedures Cataract operation	0.58% 1/171	0.00% 0/166
Vascular disorders Flushing	7.6% 13/171	1.2% 2/166
Vascular disorders Hypertension	0.58% 1/171	1.2% 2/166
Cardiac disorders Bundle branch block	0.58% 1/171	0.00% 0/166
Cardiac disorders Bundle branch block right	0.00% 0/171	0.60% 1/166
Cardiac disorders Mitral valve incompetence	0.58% 1/171	0.00% 0/166
Cardiac disorders Supraventricular extrasystoles	0.58% 1/171	0.60% 1/166
Cardiac disorders Tricuspid valve incompetence	0.58% 1/171	0.00% 0/166
Cardiac disorders Ventricular extrasystoles	1.2% 2/171	1.2% 2/166
Cardiac disorders Left ventricular hypertrophy	0.58% 1/171	0.00% 0/166
Ear and labyrinth disorders Vertigo	0.58% 1/171	0.00% 0/166
Eye disorders Diplopia	0.58% 1/171	0.00% 0/166
Eye disorders Eye pain	0.58% 1/171	0.00% 0/166
Eye disorders Vision blurred	0.58% 1/171	0.60% 1/166
Eye disorders Eye pruritus	0.58% 1/171	0.00% 0/166
Gastrointestinal disorders Abdominal pain	0.00% 0/171	0.60% 1/166
Gastrointestinal disorders Abdominal pain upper	0.58% 1/171	0.00% 0/166
Gastrointestinal disorders Colonic polyp	0.00% 0/171	0.60% 1/166
Gastrointestinal disorders Constipation	0.00% 0/171	0.60% 1/166
Gastrointestinal disorders Diarrhoea	1.8% 3/171	0.60% 1/166
Gastrointestinal disorders Dry mouth	1.2% 2/171	0.60% 1/166
Gastrointestinal disorders Dyspepsia	1.8% 3/171	0.00% 0/166
Gastrointestinal disorders Dysphagia	0.58% 1/171	0.00% 0/166
Gastrointestinal disorders Nausea	0.58% 1/171	0.00% 0/166
Gastrointestinal disorders Toothache	0.58% 1/171	0.00% 0/166
General disorders Chest discomfort	0.58% 1/171	0.00% 0/166
General disorders Chest pain	1.2% 2/171	0.00% 0/166
General disorders Fatigue	0.58% 1/171	0.00% 0/166
General disorders Feeling hot	0.58% 1/171	0.00% 0/166
General disorders Pyrexia	0.58% 1/171	0.00% 0/166
Infections and infestations Influenza	0.58% 1/171	0.00% 0/166
Infections and infestations Nasopharyngitis	0.00% 0/171	1.8% 3/166
Infections and infestations Pharyngitis	1.8% 3/171	1.8% 3/166
Infections and infestations Pharyngitis streptococcal	0.00% 0/171	0.60% 1/166
Infections and infestations Pneumonia	0.58% 1/171	0.00% 0/166
Infections and infestations Rhinitis	1.2% 2/171	0.00% 0/166
Infections and infestations Sinusitis	0.58% 1/171	1.2% 2/166
Infections and infestations Tooth abscess	0.00% 0/171	1.2% 2/166
Infections and infestations Upper respiratory tract infection	1.8% 3/171	0.00% 0/166
Infections and infestations Urinary tract infection	0.58% 1/171	0.00% 0/166
Infections and infestations Bacterial rhinitis	0.58% 1/171	0.00% 0/166
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/171	0.60% 1/166
Injury, poisoning and procedural complications Multiple injuries	0.58% 1/171	0.00% 0/166
Injury, poisoning and procedural complications Muscle injury	0.58% 1/171	0.00% 0/166
Injury, poisoning and procedural complications Contusion	0.58% 1/171	0.00% 0/166
Injury, poisoning and procedural complications Penis deviation	0.58% 1/171	0.00% 0/166
Investigations Arthroscopy	0.00% 0/171	0.60% 1/166
Investigations Blood creatinine increased	0.58% 1/171	0.00% 0/166
Investigations Blood pressure increased	1.2% 2/171	0.00% 0/166
Investigations Cardiac murmur	0.58% 1/171	0.00% 0/166
Investigations Heart rate increased	0.58% 1/171	0.00% 0/166
Metabolism and nutrition disorders Diabetes mellitus	0.58% 1/171	0.60% 1/166
Metabolism and nutrition disorders Gout	0.58% 1/171	0.00% 0/166
Metabolism and nutrition disorders Hypertriglyceridaemia	0.58% 1/171	0.00% 0/166
Metabolism and nutrition disorders Hyperlipidaemia	0.58% 1/171	0.00% 0/166
Musculoskeletal and connective tissue disorders Arthralgia	0.58% 1/171	0.60% 1/166
Musculoskeletal and connective tissue disorders Back pain	2.3% 4/171	0.60% 1/166
Musculoskeletal and connective tissue disorders Joint swelling	0.58% 1/171	0.00% 0/166
Musculoskeletal and connective tissue disorders Muscle spasms	1.2% 2/171	0.00% 0/166
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.58% 1/171	0.60% 1/166
Musculoskeletal and connective tissue disorders Myalgia	0.58% 1/171	0.00% 0/166
Musculoskeletal and connective tissue disorders Neck pain	1.2% 2/171	0.00% 0/166
Musculoskeletal and connective tissue disorders Pain in extremity	0.58% 1/171	0.00% 0/166
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.58% 1/171	0.00% 0/166
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/171	0.60% 1/166
Nervous system disorders Burning sensation	0.58% 1/171	0.00% 0/166
Nervous system disorders Dizziness	2.9% 5/171	0.00% 0/166
Nervous system disorders Headache	12.3% 21/171	2.4% 4/166
Nervous system disorders Sinus headache	0.58% 1/171	0.00% 0/166
Psychiatric disorders Anxiety	0.00% 0/171	0.60% 1/166
Reproductive system and breast disorders Prostatitis	0.00% 0/171	0.60% 1/166
Reproductive system and breast disorders Testicular pain	0.00% 0/171	0.60% 1/166
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.58% 1/171	0.00% 0/166
Respiratory, thoracic and mediastinal disorders Cough	1.2% 2/171	0.00% 0/166
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 2/171	0.00% 0/166
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.7% 8/171	0.60% 1/166
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.58% 1/171	0.00% 0/166
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/171	0.60% 1/166
Respiratory, thoracic and mediastinal disorders Wheezing	0.58% 1/171	0.00% 0/166
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/171	0.60% 1/166
Skin and subcutaneous tissue disorders Hyperhidrosis	0.58% 1/171	0.00% 0/166

Additional Information

Therapeutic Area Head

BAYER

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER