check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
11586
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Evaluating the Efficacy of Vardenafil in subjects with Erectile Dysfunction (ED) administered 12, 18 or 24 hours prior to intercourse
Trial purpose
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.
Key Participants Requirements
Sex
MaleAge
18 - 64 YearsTrial summary
Enrollment Goal
264Trial Dates
September 2004 - December 2004Phase
Phase 4Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Germany |
Primary Outcome
- Sexual encounter profile Question 3date_rangeTime Frame:6 weeksenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Safety and Tolerabilitydate_rangeTime Frame:6 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2