check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
10898
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in subjects with erectile dysfunction
Trial purpose
This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.
Key Participants Requirements
Sex
MaleAge
18 YearsTrial summary
Enrollment Goal
463Trial Dates
October 2002 - May 2003Phase
Phase 2/Phase 3Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoPrimary Outcome
- Erectile Function domain of the International Index of Erectile Functiondate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Sexual Encounter Profile Question 2date_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Sexual Encounter Profile Question 3date_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Erectile Function domain scores > 26date_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Sexual Encounter Profile 2date_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Global Assessment Questiondate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Reliability of insertiondate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Reliability of maintenancedate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Other subject 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
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2