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

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 congenital QT prolongation
  • History of surgical prostatectomy due to prostate cancer
  • Hereditary degenerative retinal disorders
  • History of loss of vision because of NAION (Non-arteritic anterior ischemic optic neuropathy), temporary or permanent loss of vision
  • Presence of penile anatomical abnormalities
  • Spinal cord injury
  • Resting or postural hypotension or hypertension
  • Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha-blockers, HIV (Human immunodeficiency virus) protease inhibitors, itraconazole or ketoconazole, and clarithromycin and erythromycin.
  • Subjects taking medication known to prolong QT interval, such as Type Ia and Type 3 anti-arrhythmics.
  • Subjects who have been confirmed with phenylketonuria (PKU).
  • Use of any treatment for ED within 7 days of Visit 1.

Sites / Locations

  • East Valley Family Physicians, PLC
  • Mesa Family Medical Center
  • Desert Clinical Research
  • Arizona Research Center, Inc.
  • Tatum Highlands Medical Associates, PLLC
  • Fiel Family & Sports Medicine, PC
  • Irvine Center for Clinical Research
  • Synergy Clinical Research Center
  • San Diego Uro-Research
  • San Diego Clinical Trials
  • South Florida Medical Research
  • Jacksonville Impotence Treatment Center
  • University Clinical Research, Inc.
  • Tulane Medical Center
  • Office of Dr. Bruce Gilbert, MD
  • Mount Sinai Medical Center
  • The Urology Group
  • Columbus Urology Research, LLC
  • Family Medical Associates
  • Pearl Clinical Research
  • Office of Dr. Roger Fincher, MD
  • Sydney Men's Health
  • Berry Road Medical Centre
  • South Terrace Urology
  • Cabrini Medical Centre
  • Queen Elizabeth II Medical Centre
  • Perth Human Sexuality Centre
  • St.Joseph's Health Care-London
  • The Male Health Centres
  • Office of Dr. Rajiv Singal, MD
  • Sunnybrook Health Sciences Centre
  • Clinique d'Urologie du Saguenay
  • Urology South Shore Research
  • Centre de Recherche en Sante Sexuelle du Quebec
  • Sir Mortimer B. Davis Jewish General Hospital
  • Hospital Dalinde
  • Consultorio Dr. Rodríguez Rivera
  • Centro Médico de las Américas
  • Asociación Mexicana para la Salud Sexual A. C.
  • Hospital Santa Fé

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 Last Observation Carried Forward (LOCF)
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'.)
Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks
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.
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; 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.
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; 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
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; 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
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; 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
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; 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
Satisfaction With Medication at Week 12 or LOCF
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
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)

Full Information

First Posted
April 4, 2008
Last Updated
July 29, 2014
Sponsor
Bayer
Collaborators
GlaxoSmithKline, Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00655629
Brief Title
Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 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
339 (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 10 mg 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 Last Observation Carried Forward (LOCF)
Description
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'.)
Time Frame
from baseline up to 12 weeks
Title
Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks
Description
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.
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; 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.
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; 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
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; 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
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; 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
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; 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
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; 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
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

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 congenital QT prolongation History of surgical prostatectomy due to prostate cancer Hereditary degenerative retinal disorders History of loss of vision because of NAION (Non-arteritic anterior ischemic optic neuropathy), temporary or permanent loss of vision Presence of penile anatomical abnormalities Spinal cord injury Resting or postural hypotension or hypertension Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha-blockers, HIV (Human immunodeficiency virus) protease inhibitors, itraconazole or ketoconazole, and clarithromycin and erythromycin. Subjects taking medication known to prolong QT interval, such as Type Ia and Type 3 anti-arrhythmics. Subjects who have been confirmed with phenylketonuria (PKU). Use of any treatment for ED within 7 days of Visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
East Valley Family Physicians, PLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Mesa Family Medical Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85203
Country
United States
Facility Name
Desert Clinical Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Arizona Research Center, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Tatum Highlands Medical Associates, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Fiel Family & Sports Medicine, PC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Irvine Center for Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92618-3603
Country
United States
Facility Name
Synergy Clinical Research Center
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
San Diego Uro-Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Diego Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Jacksonville Impotence Treatment Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32223
Country
United States
Facility Name
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Office of Dr. Bruce Gilbert, MD
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212-2787
Country
United States
Facility Name
Columbus Urology Research, LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43220
Country
United States
Facility Name
Family Medical Associates
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Pearl Clinical Research
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Office of Dr. Roger Fincher, MD
City
Spokane
State/Province
Washington
ZIP/Postal Code
99206
Country
United States
Facility Name
Sydney Men's Health
City
Bondi Junction
State/Province
New South Wales
ZIP/Postal Code
2022
Country
Australia
Facility Name
Berry Road Medical Centre
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
South Terrace Urology
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Cabrini Medical Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Queen Elizabeth II Medical Centre
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Perth Human Sexuality Centre
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
St.Joseph's Health Care-London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
The Male Health Centres
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
Office of Dr. Rajiv Singal, MD
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 5T2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Clinique d'Urologie du Saguenay
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 4A3
Country
Canada
Facility Name
Urology South Shore Research
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H3
Country
Canada
Facility Name
Centre de Recherche en Sante Sexuelle du Quebec
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
Facility Name
Sir Mortimer B. Davis Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hospital Dalinde
City
México, D. F.
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Consultorio Dr. Rodríguez Rivera
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45040
Country
Mexico
Facility Name
Centro Médico de las Américas
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97001
Country
Mexico
Facility Name
Asociación Mexicana para la Salud Sexual A. C.
City
México D. F.
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Hospital Santa Fé
City
México, D. F.
ZIP/Postal Code
06700
Country
Mexico

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
20456213
Citation
Gittelman M, McMahon CG, Rodriguez-Rivera JA, Beneke M, Ulbrich E, Ewald S. The POTENT II randomised trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. Int J Clin Pract. 2010 Apr;64(5):594-603. doi: 10.1111/j.1742-1241.2010.02358.x.
Results Reference
result

Learn more about this trial

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

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