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Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vardenafil ODT (STAXYN, BAY38-9456)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vardenafil ODT (STAXYN, BAY38-9456)

Placebo

Arm 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.

Outcomes

Primary Outcome Measures

Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
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').
Change in Percentage From Baseline in Success of Penetration at 12 Weeks
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.
Change From Baseline in Success of Erection Maintenance at 12 Weeks
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

Percentage of Subjects Achieving "Back to Normal" Erectile Function
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').
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
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.
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
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.
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
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.
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
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.
Number of Sexual Attempts Till First Successful Attempt
Change From Baseline in Ease With Erection at 12 Weeks or LOCF
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.
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
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.
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
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.
Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
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.
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
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.
Satisfaction With Medication at Week 12 or LOCF
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.
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
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)
Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

Full Information

First Posted
February 29, 2008
Last Updated
December 8, 2014
Sponsor
Bayer
Collaborators
GlaxoSmithKline, Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00631969
Brief Title
Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
GlaxoSmithKline, Schering-Plough

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
362 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vardenafil ODT (STAXYN, BAY38-9456)
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Intervention Type
Drug
Intervention Name(s)
Vardenafil ODT (STAXYN, BAY38-9456)
Intervention Description
Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
Primary Outcome Measure Information:
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
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
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
Secondary Outcome Measure Information:
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
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
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
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
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
Title
Number of Sexual Attempts Till First Successful Attempt
Time Frame
up to 12 weeks of treatment
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
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
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
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
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
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
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
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
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
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
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1000
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
City
Genk
ZIP/Postal Code
3600
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Lille
ZIP/Postal Code
59000
Country
France
City
Lyon Cedex
ZIP/Postal Code
69437
Country
France
City
Lyon
ZIP/Postal Code
69000
Country
France
City
Marseille
ZIP/Postal Code
13006
Country
France
City
Marseille
ZIP/Postal Code
13009
Country
France
City
Mont-de-marsan
ZIP/Postal Code
40000
Country
France
City
Paris
ZIP/Postal Code
75008
Country
France
City
München
State/Province
Bayern
ZIP/Postal Code
81925
Country
Germany
City
Weiden
State/Province
Bayern
ZIP/Postal Code
92637
Country
Germany
City
Osnabrück
State/Province
Niedersachsen
ZIP/Postal Code
49076
Country
Germany
City
Mönchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41063
Country
Germany
City
Mülheim
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45468
Country
Germany
City
Bautzen
State/Province
Sachsen
ZIP/Postal Code
02625
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04109
Country
Germany
City
Meißen
State/Province
Sachsen
ZIP/Postal Code
01662
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
City
Arnhem
ZIP/Postal Code
6836 BH
Country
Netherlands
City
Deurne
ZIP/Postal Code
5751 XJ
Country
Netherlands
City
Leiden
ZIP/Postal Code
2316 ZL
Country
Netherlands
City
Losser
ZIP/Postal Code
7581 BV
Country
Netherlands
City
Maastricht
ZIP/Postal Code
6212 XN
Country
Netherlands
City
Nijverdal
ZIP/Postal Code
7442 LS
Country
Netherlands
City
Centurion
State/Province
Gauteng
ZIP/Postal Code
0140
Country
South Africa
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1818
Country
South Africa
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2198
Country
South Africa
City
Krugersdorp
State/Province
Gauteng
ZIP/Postal Code
1739
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0083
Country
South Africa
City
Durban
State/Province
KwaZulu Natal
ZIP/Postal Code
4037
Country
South Africa
City
Durban
State/Province
KwaZulu Natal
ZIP/Postal Code
4091
Country
South Africa
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4001
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7463
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08034
Country
Spain
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Vigo
ZIP/Postal Code
36211
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21883954
Citation
Debruyne FM, Gittelman M, Sperling H, Borner M, Beneke M. Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med. 2011 Oct;8(10):2912-23. doi: 10.1111/j.1743-6109.2011.02462.x. Epub 2011 Aug 30.
Results Reference
result
PubMed Identifier
20233275
Citation
Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med. 2010 Apr;7(4 Pt 1):1497-507. doi: 10.1111/j.1743-6109.2010.01806.x. Epub 2010 Mar 3.
Results Reference
result
PubMed Identifier
20925442
Citation
Heinig R, Weimann B, Dietrich H, Bottcher MF. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31(1):27-41. doi: 10.2165/11584950-000000000-00000.
Results Reference
result
PubMed Identifier
20807322
Citation
Sperling H, Gittelman M, Norenberg C, Ulbrich E, Ewald S. Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. J Sex Med. 2011 Jan;8(1):261-71. doi: 10.1111/j.1743-6109.2010.02005.x. Epub 2010 Aug 30.
Results Reference
result
Links:
URL
http://www.clinicaltrialsregister.eu
Description
Click here and search for information of Bayer products for Europe

Learn more about this trial

Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction

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