check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
100541
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Evaluation of the safety and efficacy of Vardenafil in subjects with Erectile Dysfunction
Trial purpose
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.
Key Participants Requirements
Sex
MaleAge
18 YearsTrial summary
Enrollment Goal
333Trial Dates
March 2003 - November 2003Phase
Phase 4Could I Receive a placebo
NoProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Australia |
Primary Outcome
- International Index of Erectile Function - Erectile Function Domaindate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Sexual Encounter Profile Question 2 and 3date_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Global Assessment Questiondate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Other diary based variablesdate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Safety and tolerabilitydate_rangeTime Frame:12 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1