Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00655629
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 339
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. Vardenafil ODT (STAXYN, BAY38-9456) 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) from baseline up to 12 weeks 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 From Baseline in Success of Erection Maintenance at 12 Weeks from baseline up to 12 weeks of treatment 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.
Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks from baseline up to 12 weeks of treatment 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.
- Secondary Outcome Measures
Name Time Method Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks from baseline up to 12 weeks of treatment 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 from baseline up to 12 weeks of treatment 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.
Percentage of Subjects Achieving "Back to Normal" Erectile Function up to 12 weeks of treatment 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 Overall Satisfaction at 12 Weeks from baseline up to 12 weeks of treatment 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.
Number of Sexual Attempts Till First Successful Attempt up to 12 weeks of treatment Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks from baseline up to 12 weeks of treatment 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.
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF from baseline up to 12 weeks 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 Satisfaction With Orgasm at 12 Weeks or LOCF from baseline up to 12 weeks 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 Ease With Erection at 12 Weeks or LOCF from baseline up to 12 weeks 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 Confidence for Completion at 12 Weeks or LOCF from baseline up to 12 weeks 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
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale up to 12 weeks of treatment 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)
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF from baseline up to 12 weeks 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
Satisfaction With Medication at Week 12 or LOCF up to 12 weeks 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
Trial Locations
- Locations (40)
Berry Road Medical Centre
🇦🇺St Leonards, New South Wales, Australia
Synergy Clinical Research Center
🇺🇸National City, California, United States
Sydney Men's Health
🇦🇺Bondi Junction, New South Wales, Australia
East Valley Family Physicians, PLC
🇺🇸Chandler, Arizona, United States
Jacksonville Impotence Treatment Center
🇺🇸Jacksonville, Florida, United States
St.Joseph's Health Care-London
🇨🇦London, Ontario, Canada
Cabrini Medical Centre
🇦🇺Melbourne, Victoria, Australia
The Male Health Centres
🇨🇦Oakville, Ontario, Canada
Asociación Mexicana para la Salud Sexual A. C.
🇲🇽México D. F., Mexico
Hospital Santa Fé
🇲🇽México, D. F., Mexico
Clinique d'Urologie du Saguenay
🇨🇦Chicoutimi, Quebec, Canada
Urology South Shore Research
🇨🇦Greenfield Park, Quebec, Canada
Sir Mortimer B. Davis Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Centre de Recherche en Sante Sexuelle du Quebec
🇨🇦Montreal, Quebec, Canada
Hospital Dalinde
🇲🇽México, D. F., Distrito Federal, Mexico
Consultorio Dr. RodrÃguez Rivera
🇲🇽Guadalajara, Jalisco, Mexico
Family Medical Associates
🇺🇸Levittown, Pennsylvania, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Pearl Clinical Research
🇺🇸Norristown, Pennsylvania, United States
Office of Dr. Roger Fincher, MD
🇺🇸Spokane, Washington, United States
Mesa Family Medical Center
🇺🇸Mesa, Arizona, United States
Desert Clinical Research
🇺🇸Mesa, Arizona, United States
Fiel Family & Sports Medicine, PC
🇺🇸Tempe, Arizona, United States
Irvine Center for Clinical Research
🇺🇸Irvine, California, United States
San Diego Uro-Research
🇺🇸San Diego, California, United States
San Diego Clinical Trials
🇺🇸San Diego, California, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
University Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Office of Dr. Bruce Gilbert, MD
🇺🇸Great Neck, New York, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States
Columbus Urology Research, LLC
🇺🇸Columbus, Ohio, United States
South Terrace Urology
🇦🇺Adelaide, South Australia, Australia
Office of Dr. Rajiv Singal, MD
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Queen Elizabeth II Medical Centre
🇦🇺Nedlands, Western Australia, Australia
Perth Human Sexuality Centre
🇦🇺Perth, Western Australia, Australia
Arizona Research Center, Inc.
🇺🇸Phoenix, Arizona, United States
Tatum Highlands Medical Associates, PLLC
🇺🇸Phoenix, Arizona, United States
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
Centro Médico de las Américas
🇲🇽Mérida, Yucatán, Mexico