Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
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
2 other identifiers
interventional
362
6 countries
47
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2008
Shorter than P25 for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2008
CompletedFirst Posted
Study publicly available on registry
March 10, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
January 21, 2011
CompletedDecember 30, 2014
December 1, 2014
9 months
February 29, 2008
October 5, 2010
December 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
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').
from baseline up to 12 weeks
Change in Percentage From Baseline in Success of Penetration at 12 Weeks
Sexual encounter profile (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 penetrate the partner.
from baseline up to 12 weeks of treatment
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
Secondary Outcomes (17)
Percentage of Subjects Achieving "Back to Normal" Erectile Function
up to 12 weeks of treatment
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
from baseline 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
- +12 more secondary outcomes
Study Arms (2)
Vardenafil ODT (STAXYN, BAY38-9456)
EXPERIMENTALVardenafil 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
PLACEBO COMPARATORMatching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Interventions
Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)
Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- GlaxoSmithKlinecollaborator
- Schering-Ploughcollaborator
Study Sites (47)
Unknown Facility
Antwerp, 2020, Belgium
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Bruxelles - Brussel, 1000, Belgium
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Bruxelles - Brussel, 1070, Belgium
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Bruxelles - Brussel, 1200, Belgium
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Genk, 3600, Belgium
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Ghent, 9000, Belgium
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Liège, 4000, Belgium
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Lille, 59000, France
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Lyon, 69000, France
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Lyon, 69437, France
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Marseille, 13006, France
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Marseille, 13009, France
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Mont-de-Marsan, 40000, France
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Paris, 75008, France
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München, Bavaria, 81925, Germany
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Weiden, Bavaria, 92637, Germany
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Hamburg, Hamburg, 20246, Germany
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Hamburg, Hamburg, 20354, Germany
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Osnabrück, Lower Saxony, 49076, Germany
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Mönchengladbach, North Rhine-Westphalia, 41063, Germany
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Mülheim, North Rhine-Westphalia, 45468, Germany
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Bautzen, Saxony, 02625, Germany
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Leipzig, Saxony, 04109, Germany
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Meissen, Saxony, 01662, Germany
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Arnhem, 6836 BH, Netherlands
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Deurne, 5751 XJ, Netherlands
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Leiden, 2316 ZL, Netherlands
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Losser, 7581 BV, Netherlands
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Maastricht, 6212 XN, Netherlands
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Nijverdal, 7442 LS, Netherlands
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Centurion, Gauteng, 0140, South Africa
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Johannesburg, Gauteng, 1818, South Africa
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Johannesburg, Gauteng, 2198, South Africa
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Krugersdorp, Gauteng, 1739, South Africa
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Pretoria, Gauteng, 0001, South Africa
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Pretoria, Gauteng, 0083, South Africa
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Durban, KwaZulu-Natal, 4001, South Africa
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Durban, KwaZulu-Natal, 4037, South Africa
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Durban, KwaZulu-Natal, 4091, South Africa
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Cape Town, Western Cape, 7463, South Africa
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Cape Town, Western Cape, 7530, South Africa
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Alicante, Alicante, 03010, Spain
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Barcelona, Barcelona, 08003, Spain
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Barcelona, Barcelona, 08034, Spain
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San Cristóbal de La Laguna, La Laguna, 38320, Spain
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Valencia, Valencia, 46010, Spain
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Vigo, Vigo, 36211, Spain
Related Publications (4)
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.
PMID: 21883954RESULTSperling 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.
PMID: 20233275RESULTHeinig 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.
PMID: 20925442RESULTSperling 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.
PMID: 20807322RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2008
First Posted
March 10, 2008
Study Start
April 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
December 30, 2014
Results First Posted
January 21, 2011
Record last verified: 2014-12