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Trial record 88 of 115 for:    centurion

Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT00631969
Recruitment Status : Completed
First Posted : March 10, 2008
Results First Posted : January 21, 2011
Last Update Posted : December 30, 2014
Sponsor:
Collaborators:
GlaxoSmithKline
Schering-Plough
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Erectile Dysfunction
Interventions Drug: Vardenafil ODT (STAXYN, BAY38-9456)
Drug: Placebo
Enrollment 362
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 Details 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
Hide 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 [1] 174 [1]
Completed 171 155
Not Completed 15 21
Reason Not Completed
Adverse Event             3             1
Lack of Efficacy             2             8
Lost to Follow-up             2             1
Protocol Violation             1             1
Consent Withdrawn             5             7
Noncompliant With Study Medication             0             1
No Drug Exposure             2             2
[1]
safety population
Arm/Group Title Vardenafil ODT (STAXYN, BAY38-9456) Placebo Total
Hide 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 Number of Baseline Participants 184 174 358
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 184 participants 174 participants 358 participants
<65 years 87 81 168
>=65 years 97 93 190
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 174 participants 358 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
184
 100.0%
174
 100.0%
358
 100.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilograms per square meter (kg/m^2)
Number Analyzed 184 participants 174 participants 358 participants
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)
1.Primary Outcome
Title Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 183 172
Mean (Standard Deviation)
Unit of Measure: scores on a scale
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.109
Confidence Interval 95%
-8.562 to -5.6561
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in Percentage From Baseline in Success of Penetration at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 179 169
Mean (Standard Deviation)
Unit of Measure: percentage of successful penetrations
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29.027
Confidence Interval 95%
-35.519 to -22.534
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Success of Erection Maintenance at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 178 164
Mean (Standard Deviation)
Unit of Measure: percentage of success in maintenance
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -38.193
Confidence Interval 95%
-45.021 to -31.366
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Subjects Achieving "Back to Normal" Erectile Function
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 181 172
Measure Type: Number
Unit of Measure: percentage of participants
<65 years 46 13
≥65 years 34 11
Total 40 12
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
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
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 180 169
Mean (Standard Deviation)
Unit of Measure: percentage of successful erections
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.503
Confidence Interval 95%
-22.424 to -10.764
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 179 164
Mean (Standard Deviation)
Unit of Measure: percentage of satisfactory erections
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -38.167
Confidence Interval 95%
-45.261 to -31.073
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 178 164
Mean (Standard Deviation)
Unit of Measure: percentage of satisfactory attempts
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -36.555
Confidence Interval 95%
-43.645 to -29.465
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 179 163
Mean (Standard Deviation)
Unit of Measure: percentage of ejaculation successes
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -25.193
Confidence Interval 95%
-31.562 to -18.824
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Sexual Attempts Till First Successful Attempt
Hide Description [Not Specified]
Time Frame up to 12 weeks of treatment
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 180 169
Mean (Standard Deviation)
Unit of Measure: Sexual Attempts
<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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 180 168
Mean (Standard Deviation)
Unit of Measure: scores on a scale
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.703
Confidence Interval 95%
-30.067 to -19.340
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 180 168
Mean (Standard Deviation)
Unit of Measure: scores on a scale
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.496
Confidence Interval 95%
-34.865 to -24.128
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 180 168
Mean (Standard Deviation)
Unit of Measure: scores on a scale
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -27.775
Confidence Interval 95%
-33.155 to -22.394
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 180 168
Mean (Standard Deviation)
Unit of Measure: scores on a scale
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.326
Confidence Interval 95%
-29.062 to -17.598
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 180 168
Mean (Standard Deviation)
Unit of Measure: scores on a scale
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.384
Confidence Interval 95%
-28.594 to -18.175
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Satisfaction With Medication at Week 12 or LOCF
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 180 167
Mean (Standard Deviation)
Unit of Measure: scores on a scale
<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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -33.076
Confidence Interval 95%
-38.745 to -27.407
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 180 168
Measure Type: Number
Unit of Measure: percentage of participants
<65 years 76 30
≥65 years 69 22
Total 72 26
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
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
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Full Range)
Unit of Measure: μg*h/L
47.16
(18.97 to 112.8)
55.37
(21.23 to 104.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ED Patients Aged < 65 Years, ED Patients Aged ≥ 65 Years
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.
Method of Estimation Estimation Parameter Point estimate of ratio
Estimated Value 117.42
Confidence Interval 90%
79.59 to 173.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ED Patients Aged < 65 Years, ED Patients Aged ≥ 65 Years
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 [Not Specified]
Method Regression, Linear
Comments [Not Specified]
18.Secondary Outcome
Title Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 12 13
Geometric Mean (Full Range)
Unit of Measure: μg/L
10.09
(3.134 to 19.04)
13.43
(2.913 to 27.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ED Patients Aged < 65 Years, ED Patients Aged ≥ 65 Years
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.
Method of Estimation Estimation Parameter Point estimate of ratio
Estimated Value 133.07
Confidence Interval 90%
87.46 to 202.46
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ED Patients Aged < 65 Years, ED Patients Aged ≥ 65 Years
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 [Not Specified]
Method Regression, Linear
Comments [Not Specified]
19.Secondary Outcome
Title Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 12 10
Geometric Mean (Full Range)
Unit of Measure: µg*h/L
33.36
(10.94 to 68.46)
41.80
(16.56 to 148.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ED Patients Aged < 65 Years, ED Patients Aged ≥ 65 Years
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.
Method of Estimation Estimation Parameter Point estimate of ratio
Estimated Value 125.28
Confidence Interval 90%
73.65 to 213.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ED Patients Aged < 65 Years, ED Patients Aged ≥ 65 Years
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 [Not Specified]
Method Regression, Linear
Comments [Not Specified]
20.Secondary Outcome
Title Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 12 13
Geometric Mean (Full Range)
Unit of Measure: µg/L
9.260
(3.756 to 23.32)
11.47
(5.563 to 41.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ED Patients Aged < 65 Years, ED Patients Aged ≥ 65 Years
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.
Method of Estimation Estimation Parameter Point estimate of ratio
Estimated Value 123.84
Confidence Interval 90%
80.12 to 191.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ED Patients Aged < 65 Years, ED Patients Aged ≥ 65 Years
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 [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vardenafil ODT (STAXYN, BAY 38-9456) Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vardenafil ODT (STAXYN, BAY 38-9456) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/184 (2.17%)   1/174 (0.57%) 
Cardiac disorders     
Acute coronary syndrome * 1  1/184 (0.54%)  0/174 (0.00%) 
Ear and labyrinth disorders     
Deafness neurosensory * 1  0/184 (0.00%)  1/174 (0.57%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage * 1  1/184 (0.54%)  0/174 (0.00%) 
Nervous system disorders     
Syncope * 1  1/184 (0.54%)  0/174 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax * 1  1/184 (0.54%)  0/174 (0.00%) 
Vascular disorders     
Femoral arterial stenosis * 1  1/184 (0.54%)  0/174 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vardenafil ODT (STAXYN, BAY 38-9456) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   70/184 (38.04%)   36/174 (20.69%) 
Cardiac disorders     
Angina pectoris * 1  0/184 (0.00%)  1/174 (0.57%) 
Bundle branch block left * 1  1/184 (0.54%)  1/174 (0.57%) 
Bundle branch block right * 1  0/184 (0.00%)  3/174 (1.72%) 
Mitral valve incompetence * 1  0/184 (0.00%)  1/174 (0.57%) 
Palpitations * 1  1/184 (0.54%)  1/174 (0.57%) 
Supraventricular extrasystoles * 1  3/184 (1.63%)  2/174 (1.15%) 
Tachycardia * 1  0/184 (0.00%)  1/174 (0.57%) 
Ventricular extrasystoles * 1  1/184 (0.54%)  0/174 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  1/184 (0.54%)  0/174 (0.00%) 
Eye disorders     
Conjunctival haemorrhage * 1  1/184 (0.54%)  0/174 (0.00%) 
Eye disorder * 1  1/184 (0.54%)  0/174 (0.00%) 
Eye irritation * 1  1/184 (0.54%)  0/174 (0.00%) 
Ocular hyperaemia * 1  1/184 (0.54%)  0/174 (0.00%) 
Vision blurred * 1  0/184 (0.00%)  1/174 (0.57%) 
Gastrointestinal disorders     
Colitis * 1  1/184 (0.54%)  0/174 (0.00%) 
Diarrhoea * 1  3/184 (1.63%)  2/174 (1.15%) 
Dyspepsia * 1  7/184 (3.80%)  0/174 (0.00%) 
Salivary gland calculus * 1  1/184 (0.54%)  0/174 (0.00%) 
General disorders     
Asthenia * 1  1/184 (0.54%)  0/174 (0.00%) 
Chest pain * 1  0/184 (0.00%)  1/174 (0.57%) 
Fatigue * 1  2/184 (1.09%)  0/174 (0.00%) 
Feeling hot * 1  2/184 (1.09%)  0/174 (0.00%) 
Oedema * 1  1/184 (0.54%)  0/174 (0.00%) 
Pyrexia * 1  1/184 (0.54%)  0/174 (0.00%) 
Sluggishness * 1  0/184 (0.00%)  1/174 (0.57%) 
Induration * 1  1/184 (0.54%)  0/174 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis * 1  1/184 (0.54%)  0/174 (0.00%) 
Infections and infestations     
Acute sinusitis * 1  1/184 (0.54%)  0/174 (0.00%) 
Bronchitis * 1  0/184 (0.00%)  1/174 (0.57%) 
Gastroenteritis * 1  1/184 (0.54%)  0/174 (0.00%) 
Herpes zoster * 1  1/184 (0.54%)  0/174 (0.00%) 
Influenza * 1  1/184 (0.54%)  1/174 (0.57%) 
Nasopharyngitis * 1  2/184 (1.09%)  1/174 (0.57%) 
Tooth abscess * 1  0/184 (0.00%)  1/174 (0.57%) 
Tooth infection * 1  0/184 (0.00%)  1/174 (0.57%) 
Injury, poisoning and procedural complications     
Muscle injury * 1  0/184 (0.00%)  1/174 (0.57%) 
Excoriation * 1  1/184 (0.54%)  0/174 (0.00%) 
Muscle strain * 1  1/184 (0.54%)  1/174 (0.57%) 
Skeletal injury * 1  1/184 (0.54%)  0/174 (0.00%) 
Neck injury * 1  1/184 (0.54%)  0/174 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  1/184 (0.54%)  0/174 (0.00%) 
Platelet count decreased * 1  0/184 (0.00%)  1/174 (0.57%) 
Platelet count increased * 1  1/184 (0.54%)  0/174 (0.00%) 
Metabolism and nutrition disorders     
Gout * 1  0/184 (0.00%)  1/174 (0.57%) 
Hypercholesterolaemia * 1  0/184 (0.00%)  1/174 (0.57%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  3/184 (1.63%)  0/174 (0.00%) 
Muscle spasms * 1  2/184 (1.09%)  2/174 (1.15%) 
Myalgia * 1  2/184 (1.09%)  0/174 (0.00%) 
Osteoarthritis * 1  1/184 (0.54%)  0/174 (0.00%) 
Pain in extremity * 1  1/184 (0.54%)  0/174 (0.00%) 
Intervertebral disc protrusion * 1  1/184 (0.54%)  0/174 (0.00%) 
Foot deformity * 1  0/184 (0.00%)  1/174 (0.57%) 
Nervous system disorders     
Dizziness * 1  3/184 (1.63%)  0/174 (0.00%) 
Dysgeusia * 1  4/184 (2.17%)  4/174 (2.30%) 
Headache * 1  30/184 (16.30%)  2/174 (1.15%) 
Memory impairment * 1  0/184 (0.00%)  1/174 (0.57%) 
Paraesthesia * 1  1/184 (0.54%)  0/174 (0.00%) 
Tension headache * 1  1/184 (0.54%)  0/174 (0.00%) 
Psychiatric disorders     
Libido decreased * 1  0/184 (0.00%)  1/174 (0.57%) 
Renal and urinary disorders     
Haematuria * 1  0/184 (0.00%)  1/174 (0.57%) 
Polyuria * 1  1/184 (0.54%)  0/174 (0.00%) 
Reproductive system and breast disorders     
Prostatitis * 1  1/184 (0.54%)  0/174 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dry throat * 1  1/184 (0.54%)  1/174 (0.57%) 
Dysphonia * 1  0/184 (0.00%)  1/174 (0.57%) 
Dyspnoea * 1  0/184 (0.00%)  1/174 (0.57%) 
Nasal congestion * 1  3/184 (1.63%)  0/174 (0.00%) 
Rhinorrhoea * 1  0/184 (0.00%)  1/174 (0.57%) 
Skin and subcutaneous tissue disorders     
Erythema * 1  1/184 (0.54%)  0/174 (0.00%) 
Hyperhidrosis * 1  0/184 (0.00%)  1/174 (0.57%) 
Photosensitivity reaction * 1  1/184 (0.54%)  0/174 (0.00%) 
Pruritus * 1  1/184 (0.54%)  0/174 (0.00%) 
Rash * 1  1/184 (0.54%)  0/174 (0.00%) 
Social circumstances     
Pharmaceutical product complaint * 1  0/184 (0.00%)  3/174 (1.72%) 
Surgical and medical procedures     
Meniscus removal * 1  0/184 (0.00%)  1/174 (0.57%) 
Tooth extraction * 1  0/184 (0.00%)  1/174 (0.57%) 
Vascular disorders     
Flushing * 1  14/184 (7.61%)  0/174 (0.00%) 
Hypertension * 1  1/184 (0.54%)  1/174 (0.57%) 
Orthostatic hypotension * 1  2/184 (1.09%)  2/174 (1.15%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00631969     History of Changes
Other Study ID Numbers: 12093
2008-000536-40 ( EudraCT Number )
First Submitted: February 29, 2008
First Posted: March 10, 2008
Results First Submitted: October 5, 2010
Results First Posted: January 21, 2011
Last Update Posted: December 30, 2014