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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655629
• Other study ID #: 12094
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2008
• Last updated: July 29, 2014
• Start date: April 2008
• Est. completion date: February 2009

Study information

• Verified date: July 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Vardenafil ODT (STAXYN, BAY38-9456)
Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT)
• Placebo
Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

Locations

Country	Name	City	State
Australia	South Terrace Urology	Adelaide	South Australia
Australia	Sydney Men's Health	Bondi Junction	New South Wales
Australia	Cabrini Medical Centre	Melbourne	Victoria
Australia	Queen Elizabeth II Medical Centre	Nedlands	Western Australia
Australia	Perth Human Sexuality Centre	Perth	Western Australia
Australia	Berry Road Medical Centre	St Leonards	New South Wales
Canada	Clinique d'Urologie du Saguenay	Chicoutimi	Quebec
Canada	Urology South Shore Research	Greenfield Park	Quebec
Canada	St.Joseph's Health Care-London	London	Ontario
Canada	Centre de Recherche en Sante Sexuelle du Quebec	Montreal	Quebec
Canada	Sir Mortimer B. Davis Jewish General Hospital	Montreal	Quebec
Canada	The Male Health Centres	Oakville	Ontario
Canada	Office of Dr. Rajiv Singal, MD	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Mexico	Consultorio Dr. Rodríguez Rivera	Guadalajara	Jalisco
Mexico	Centro Médico de las Américas	Mérida	Yucatán
Mexico	Asociación Mexicana para la Salud Sexual A. C.	México D. F.
Mexico	Hospital Dalinde	México, D. F.	Distrito Federal
Mexico	Hospital Santa Fé	México, D. F.
United States	South Florida Medical Research	Aventura	Florida
United States	East Valley Family Physicians, PLC	Chandler	Arizona
United States	The Urology Group	Cincinnati	Ohio
United States	Columbus Urology Research, LLC	Columbus	Ohio
United States	Office of Dr. Bruce Gilbert, MD	Great Neck	New York
United States	Irvine Center for Clinical Research	Irvine	California
United States	Jacksonville Impotence Treatment Center	Jacksonville	Florida
United States	Family Medical Associates	Levittown	Pennsylvania
United States	Desert Clinical Research	Mesa	Arizona
United States	Mesa Family Medical Center	Mesa	Arizona
United States	Synergy Clinical Research Center	National City	California
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	Pearl Clinical Research	Norristown	Pennsylvania
United States	University Clinical Research, Inc.	Pembroke Pines	Florida
United States	Arizona Research Center, Inc.	Phoenix	Arizona
United States	Tatum Highlands Medical Associates, PLLC	Phoenix	Arizona
United States	San Diego Clinical Trials	San Diego	California
United States	San Diego Uro-Research	San Diego	California
United States	Office of Dr. Roger Fincher, MD	Spokane	Washington
United States	Fiel Family & Sports Medicine, PC	Tempe	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Bayer	GlaxoSmithKline, Schering-Plough

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Mexico, 

References & Publications (2)

Debruyne FM, Gittelman M, Sperling H, Börner 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.1 — View Citation

Gittelman M, McMahon CG, Rodríguez-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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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'.)	from baseline up to 12 weeks	No
Primary	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.	from baseline up to 12 weeks of treatment	No
Primary	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.	from baseline up to 12 weeks of treatment	No
Secondary	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').	up to 12 weeks of treatment	No
Secondary	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.	from baseline up to 12 weeks of treatment	No
Secondary	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.	from baseline up to 12 weeks of treatment	No
Secondary	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.	from baseline up to 12 weeks of treatment	No
Secondary	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.	from baseline up to 12 weeks of treatment	No
Secondary	Number of Sexual Attempts Till First Successful Attempt		up to 12 weeks of treatment	No
Secondary	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.	from baseline up to 12 weeks	No
Secondary	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	from baseline up to 12 weeks	No
Secondary	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	from baseline up to 12 weeks	No
Secondary	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	from baseline up to 12 weeks	No
Secondary	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	from baseline up to 12 weeks	No
Secondary	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	up to 12 weeks	No
Secondary	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)	up to 12 weeks of treatment	No

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