Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia
A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study to Assess the Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia
2 other identifiers
interventional
222
1 country
15
Brief Summary
Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg BID.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2005
Shorter than P25 for phase_2
15 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
Study Start
First participant enrolled
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 9, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedOctober 28, 2014
October 1, 2014
April 9, 2008
October 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
International Prostate Symptom Score and maximal urinary flow
8 weeks
Secondary Outcomes (3)
International Prostate Symptom Score, storing and voiding subscore
8 weeks
IIEF-EF domains score
8 weeks
Safety and tolerability
8 weeks
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Males 45 to 64 years of age
- Lower urinary tract symptoms \> 6 months
- International Prostate Symptom Score \> 12
You may not qualify if:
- Prostate Specific Antigen \> 3 ng/ml
- Residual urine volume \> 150 m
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Nitrate use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (15)
Unknown Facility
Biberach, Baden-Württemberg / 277, 88400, Germany
Unknown Facility
München, Bayern / 280, 81925, Germany
Unknown Facility
Rosenheim, Bayern / 280, 83022, Germany
Unknown Facility
Starnberg, Bayern / 280, 82319, Germany
Unknown Facility
Weiden, Bayern / 280, 92637, Germany
Unknown Facility
Hamburg, Hamburg / 287, 20251, Germany
Unknown Facility
Hamburg, Hamburg / 287, 20354, Germany
Unknown Facility
Marburg, Hessen / 307, 35039, Germany
Unknown Facility
Tostedt, Niedersachsen / 292, 21255, Germany
Unknown Facility
Osnabrück, Niedersachsen / 293, 49076, Germany
Unknown Facility
Düsseldorf, Nordrhein-Westfalen / 296, 40210, Germany
Unknown Facility
Leverkusen, Nordrhein-Westfalen / 331, 51373, Germany
Unknown Facility
Mülheim, Nordrhein-Westfalen / 481, 45468, Germany
Unknown Facility
Leipzig, Sachsen / 313, 04105, Germany
Unknown Facility
Kiel, Schleswig-Holstein / 306, 24105, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2008
First Posted
April 14, 2008
Study Start
October 1, 2005
Study Completion
June 1, 2006
Last Updated
October 28, 2014
Record last verified: 2014-10