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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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.
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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
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Secondary ID [1]
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12094
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Erectile Dysfunction
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Mental Health
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Other mental health disorders
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Reproductive Health and Childbirth
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)
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Assessment method [1]
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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'.)
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Timepoint [1]
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from baseline up to 12 weeks
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Primary outcome [2]
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Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks
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Assessment method [2]
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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.
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Timepoint [2]
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from baseline up to 12 weeks of treatment
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Primary outcome [3]
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Change From Baseline in Success of Erection Maintenance at 12 Weeks
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Assessment method [3]
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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.
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Timepoint [3]
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from baseline up to 12 weeks of treatment
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Secondary outcome [1]
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Percentage of Subjects Achieving "Back to Normal" Erectile Function
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Assessment method [1]
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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').
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Timepoint [1]
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up to 12 weeks of treatment
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Secondary outcome [2]
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Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
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Assessment method [2]
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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.
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Timepoint [2]
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from baseline up to 12 weeks of treatment
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Secondary outcome [3]
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Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
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Assessment method [3]
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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.
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Timepoint [3]
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from baseline up to 12 weeks of treatment
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Secondary outcome [4]
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Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
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Assessment method [4]
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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.
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Timepoint [4]
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from baseline up to 12 weeks of treatment
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Secondary outcome [5]
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Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
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Assessment method [5]
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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.
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Timepoint [5]
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from baseline up to 12 weeks of treatment
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Secondary outcome [6]
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Number of Sexual Attempts Till First Successful Attempt
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Assessment method [6]
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Timepoint [6]
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up to 12 weeks of treatment
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Secondary outcome [7]
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Change From Baseline in Ease With Erection at 12 Weeks or LOCF
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Assessment method [7]
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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.
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Timepoint [7]
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from baseline up to 12 weeks
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Secondary outcome [8]
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Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
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Assessment method [8]
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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
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Timepoint [8]
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from baseline up to 12 weeks
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Secondary outcome [9]
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Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
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Assessment method [9]
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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
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Timepoint [9]
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from baseline up to 12 weeks
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Secondary outcome [10]
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Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
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Assessment method [10]
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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
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Timepoint [10]
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from baseline up to 12 weeks
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Secondary outcome [11]
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Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
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Assessment method [11]
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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
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Timepoint [11]
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from baseline up to 12 weeks
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Secondary outcome [12]
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Satisfaction With Medication at Week 12 or LOCF
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Assessment method [12]
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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
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Timepoint [12]
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up to 12 weeks
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Secondary outcome [13]
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Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
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Assessment method [13]
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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)
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Timepoint [13]
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up to 12 weeks of treatment
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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
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Minimum age
18
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2009
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Sample size
Target
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Accrual to date
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Final
339
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Sydney Men's Health - Bondi Junction
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Recruitment hospital [2]
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Berry Road Medical Centre - St Leonards
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Recruitment hospital [3]
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South Terrace Urology - Adelaide
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Recruitment hospital [4]
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Cabrini Medical Centre - Melbourne
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Recruitment hospital [5]
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Queen Elizabeth II Medical Centre - Nedlands
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Recruitment hospital [6]
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Perth Human Sexuality Centre - Perth
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Recruitment postcode(s) [1]
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2022 - Bondi Junction
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3144 - Melbourne
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment postcode(s) [6]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Louisiana
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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Ohio
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United States of America
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State/province [7]
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Pennsylvania
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Country [8]
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United States of America
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State/province [8]
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Washington
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Country [9]
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Canada
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State/province [9]
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Ontario
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Country [10]
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Canada
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State/province [10]
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Quebec
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Country [11]
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Mexico
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State/province [11]
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Distrito Federal
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Country [12]
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Mexico
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State/province [12]
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Jalisco
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Country [13]
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Mexico
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State/province [13]
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Yucatán
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Country [14]
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Mexico
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State/province [14]
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México D. F.
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Country [15]
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Mexico
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State/province [15]
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México, D. F.
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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GlaxoSmithKline
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Address [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Schering-Plough
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Address [2]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00655629
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bayer Study Director
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Address
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Bayer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00655629
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