check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
11382
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
BAY38-9456, 5/10/20mg, vs.placebo in Erectile Dysfunction
Trial purpose
Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo
Key Participants Requirements
Sex
MaleAge
18 - 64 YearsTrial summary
Enrollment Goal
160Trial Dates
August 2004 - August 2005Phase
Phase 4Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Dokuz Eylul Universitesi | Izmir, 35340, Turkey |
Completed | Cukurova Universitesi Tip Fakultesi Hastanesi | Adana, 01330, Turkey |
Completed | Istanbul Universitesi Cerrahpasa Tip Fakultesi | Istanbul, 34098, Turkey |
Completed | Marmara University Medical Faculty | Istanbul, 34662, Turkey |
Completed | 19 Mayis Univ. Tip Fak. | Samsun, 55139, Turkey |
Completed | Akdeniz Univ. Medical Faculty | Antalya, 07003, Turkey |
Completed | Gazi Univ. Medical Faculty | Ankara, 06500, Turkey |
Completed | Hacettepe Univ. Medical Faculty | Ankara, 06100, Turkey |
Primary Outcome
- LOCF improved compared to baseline GAQ results at the end of the studydate_rangeTime Frame:baseline versus visit 2 visit 5 or premature termination visitenhanced_encryptionnoSafety Issue:
Secondary Outcome
- IIEF scoresdate_rangeTime Frame:visits 3, 4 and 5enhanced_encryptionnoSafety Issue:
- OF, SD, IS scores in IIEF Questionnairedate_rangeTime Frame:visits 2, 3, 4, 5 or at premature termination visitenhanced_encryptionnoSafety Issue:
- Scores of all individual questions on IIEF questionnairedate_rangeTime Frame:visits 2, 3, 4, 5 or at premature termination visitenhanced_encryptionnoSafety Issue:
- Subject's diary responsedate_rangeTime Frame:baseline and after randomization per visit periodenhanced_encryptionnoSafety Issue:
- SSES-E scoresdate_rangeTime Frame:visits 2 and 5 or premature termination visitenhanced_encryptionnoSafety Issue:
- Summary score from the responses to SSES-Edate_rangeTime Frame:visits 2 and 5 or premature termination visitenhanced_encryptionnoSafety Issue:
- Response scores and summary score from the responses to the SF-36date_rangeTime Frame:visits 2 and 5 or premature termination visitenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2