Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
A Pilot, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Vardenafil Versus Placebo Administered 12, 18 and 24 Hours Prior to Initiation of Sexual Intercourse in Subjects With ED
1 other identifier
interventional
264
0 countries
N/A
Brief Summary
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2004
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 24, 2008
CompletedFirst Posted
Study publicly available on registry
April 28, 2008
CompletedJune 30, 2009
June 1, 2009
April 24, 2008
June 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sexual encounter profile Question 3
6 weeks
Secondary Outcomes (1)
Safety and Tolerability
6 weeks
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
10mg and 20mg to be taken 12, 18, 24 hours prior to sexual intercourse
Eligibility Criteria
You may qualify if:
- Men \>/= 18 years of age
- ED \>/= 6 months
- Stable sexual relationship for \> 6 months
You may not qualify if:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- Nitrate therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- GlaxoSmithKlinecollaborator
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 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 24, 2008
First Posted
April 28, 2008
Study Start
September 1, 2004
Study Completion
December 1, 2004
Last Updated
June 30, 2009
Record last verified: 2009-06