Clinical trial NCT00631969: Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
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 - POTENT I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
name: Schering-Plough
First posted: 2008-03-10
Enrollment: 362
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 surgical prostatectomy for prostate cancer
* Hereditary degenerative retinal disorders
* History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision
* Presence of penile anatomical abnormalities
* Subjects who have been confirmed with phenylketonuria (PKU)
* Spinal cord injury
* Resting or postural hypotension or hypertension
* Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin
* Use of any treatment for ED within 7 days of Visit 1
* History of congenital QT prolongation
* History of syncope within the last 6 months prior to entry into the study

Primary outcomes:
measure: Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
timeFrame: from baseline up to 12 weeks
measure: Change in Percentage From Baseline in Success of Penetration at 12 Weeks
timeFrame: from baseline up to 12 weeks of treatment
measure: Change From Baseline in Success of Erection Maintenance at 12 Weeks
timeFrame: from baseline up to 12 weeks of treatment
Secondary outcomes:
measure: Percentage of Subjects Achieving "Back to Normal" Erectile Function
timeFrame: up to 12 weeks of treatment
measure: Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
timeFrame: from baseline up to 12 weeks of treatment
measure: Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
timeFrame: from baseline up to 12 weeks of treatment
measure: Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
timeFrame: from baseline up to 12 weeks of treatment
measure: Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
timeFrame: from baseline up to 12 weeks of treatment
measure: Number of Sexual Attempts Till First Successful Attempt
timeFrame: up to 12 weeks of treatment
measure: Change From Baseline in Ease With Erection at 12 Weeks or LOCF
timeFrame: from baseline up to 12 weeks
measure: Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
timeFrame: from baseline up to 12 weeks
measure: Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
timeFrame: from baseline up to 12 weeks
measure: Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
timeFrame: from baseline up to 12 weeks
measure: Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
timeFrame: from baseline up to 12 weeks
measure: Satisfaction With Medication at Week 12 or LOCF
timeFrame: up to 12 weeks
measure: Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
timeFrame: up to 12 weeks of treatment
measure: Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma
timeFrame: Visit 5 after 12 weeks of treatment
measure: Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma
timeFrame: Visit 5 after 12 weeks of treatment
measure: Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma
timeFrame: Visit 5 after 12 weeks of treatment
measure: Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma
timeFrame: Visit 5 after 12 weeks of treatment
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Liege
country: Belgium
city: Lille
country: France
city: Lyon Cedex
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Mont-de-marsan
country: France
city: Paris
country: France
city: München
country: Germany
state: Bayern
city: Weiden
country: Germany
state: Bayern
city: Osnabrück
country: Germany
state: Niedersachsen
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
city: Mülheim
country: Germany
state: Nordrhein-Westfalen
city: Bautzen
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Meißen
country: Germany
state: Sachsen
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Arnhem
country: Netherlands
city: Deurne
country: Netherlands
city: Leiden
country: Netherlands
city: Losser
country: Netherlands
city: Maastricht
country: Netherlands
city: Nijverdal
country: Netherlands
city: Centurion
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Krugersdorp
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Durban
country: South Africa
state: KwaZulu Natal
city: Durban
country: South Africa
state: KwaZulu Natal
city: Durban
country: South Africa
state: Kwazulu-Natal
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: La Laguna
country: Spain
city: Valencia
country: Spain
city: Vigo
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.
citation: Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med. 2010 Apr;7(4 Pt 1):1497-507. doi: 10.1111/j.1743-6109.2010.01806.x. Epub 2010 Mar 3.
citation: Heinig R, Weimann B, Dietrich H, Bottcher MF. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31(1):27-41. doi: 10.2165/11584950-000000000-00000.
citation: Sperling H, Gittelman M, Norenberg C, Ulbrich E, Ewald S. Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. J Sex Med. 2011 Jan;8(1):261-71. doi: 10.1111/j.1743-6109.2010.02005.x. Epub 2010 Aug 30.