check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
100539
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Evaluating the efficacy and safety of vardenafil in subjects with erectile dysfunction and hypertension
Trial purpose
Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure
Key Participants Requirements
Sex
MaleAge
18 YearsTrial summary
Enrollment Goal
388Trial Dates
February 2003 - September 2003Phase
Phase 3Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Primary Outcome
- Sexual Encounter Profile (SEP), questions 2 and 3date_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
Secondary Outcome
- International Index of Erectile Function (IIEF) - EF (Erectile Function) domaindate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Global Assessment Questionnaire (GAQ)date_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