check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
10695
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.
Trial purpose
To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.
Key Participants Requirements
Sex
MaleAge
21 YearsTrial summary
Enrollment Goal
173Trial Dates
May 2003 - February 2004Phase
Phase 3Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Mumbai, 400007, India | |
Completed | Belagum, 590010, India | |
Completed | Madurai, 625107, India | |
Completed | Mumbai, 400022, India | |
Completed | Bangalore, 560010, India | |
Completed | Bangalore, 560054, India |
Primary Outcome
- Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15date_rangeTime Frame:At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts.enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Success in penetration and maintenance as recorded in subject diariesdate_rangeTime Frame:At Weeks 4, 8 and 12 (as observed and at LOCF)enhanced_encryptionnoSafety Issue:
- Scores for questions 3 and 4 of the IIEFdate_rangeTime Frame:At Weeks 4, 8 and 12 (as observed and at LOCF)enhanced_encryptionnoSafety Issue:
- Other IIEF domain scoresdate_rangeTime Frame:At Week 12 (observed and at LOCF)enhanced_encryptionnoSafety Issue:
- Global Assessment Question (GAQ) responsesdate_rangeTime Frame:At Weeks 4, 8 and 12 (as observed and at LOCF)enhanced_encryptionnoSafety Issue:
- Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use.date_rangeTime Frame:At Weeks 4, 8 and 12 (as observed and at LOCF)enhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2