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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00655629




Registration number
NCT00655629
Ethics application status
Date submitted
4/04/2008
Date registered
10/04/2008
Date last updated
1/08/2014

Titles & IDs
Public title
Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.
Scientific 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
Secondary ID [1] 0 0
12094
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erectile Dysfunction 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Mental Health 0 0 0 0
Other mental health disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vardenafil ODT (STAXYN, BAY38-9456)
Treatment: Drugs - Placebo

Experimental: Vardenafil ODT (STAXYN, BAY38-9456) - Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.

Placebo Comparator: Placebo - Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.


Treatment: Drugs: Vardenafil ODT (STAXYN, BAY38-9456)
Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT)

Treatment: Drugs: Placebo
Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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'.)
Timepoint [1] 0 0
from baseline up to 12 weeks
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
from baseline up to 12 weeks of treatment
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
from baseline up to 12 weeks of treatment
Secondary outcome [1] 0 0
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').
Timepoint [1] 0 0
up to 12 weeks of treatment
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
from baseline up to 12 weeks of treatment
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
from baseline up to 12 weeks of treatment
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
from baseline up to 12 weeks of treatment
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
from baseline up to 12 weeks of treatment
Secondary outcome [6] 0 0
Number of Sexual Attempts Till First Successful Attempt
Timepoint [6] 0 0
up to 12 weeks of treatment
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
from baseline up to 12 weeks
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
from baseline up to 12 weeks
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
from baseline up to 12 weeks
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
from baseline up to 12 weeks
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
from baseline up to 12 weeks
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
up to 12 weeks
Secondary outcome [13] 0 0
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)
Timepoint [13] 0 0
up to 12 weeks of treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Men's Health - Bondi Junction
Recruitment hospital [2] 0 0
Berry Road Medical Centre - St Leonards
Recruitment hospital [3] 0 0
South Terrace Urology - Adelaide
Recruitment hospital [4] 0 0
Cabrini Medical Centre - Melbourne
Recruitment hospital [5] 0 0
Queen Elizabeth II Medical Centre - Nedlands
Recruitment hospital [6] 0 0
Perth Human Sexuality Centre - Perth
Recruitment postcode(s) [1] 0 0
2022 - Bondi Junction
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3144 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Mexico
State/province [11] 0 0
Distrito Federal
Country [12] 0 0
Mexico
State/province [12] 0 0
Jalisco
Country [13] 0 0
Mexico
State/province [13] 0 0
Yucatán
Country [14] 0 0
Mexico
State/province [14] 0 0
México D. F.
Country [15] 0 0
Mexico
State/province [15] 0 0
México, D. F.

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Schering-Plough
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00655629
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications