check_circleStudy Completed
Erectile Dysfunction, Diabetes Mellitus
Bayer Identifier:
100607
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
BAY38-9456 - Pivotal trial for diabetes patient
Trial purpose
The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.
Key Participants Requirements
Sex
MaleAge
20 - 64 YearsTrial summary
Enrollment Goal
790Trial Dates
January 2004 - November 2004Phase
Phase 3Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoPrimary Outcome
- The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15date_rangeTime Frame:At 12 weeks after start of study drug administration using data at LOCF to account for dropoutsenhanced_encryptionnoSafety Issue:
Secondary Outcome
- The Global Assessment Questiondate_rangeTime Frame:At 4, 8, 12 weeks after start of study drug administration and LOCFenhanced_encryptionnoSafety Issue:
- The IIEF EF domain scoredate_rangeTime Frame:At 4, 8, 12 weeks after start of study drug administrationenhanced_encryptionnoSafety Issue:
- IIEF domain scores other than the EF domain score[intercourse satisfaction (Q6 to Q8), overall satisfaction (Q13, Q14), orgasmic function (Q9, Q10), sexual desire (Q11, Q12)]date_rangeTime Frame:At 4, 8, 12 weeks after start of study drug administration and LOCFenhanced_encryptionnoSafety Issue:
- Scores of Questions 1 to 15 on the IIEF Questionnairedate_rangeTime Frame:At 4, 8, 12 weeks after start of study drug administration and LOCFenhanced_encryptionnoSafety Issue:
- Patient's diary response concerning hardness of erection, maintenance of erection, satisfaction with overall hardness of erection, ability of insertion, overall satisfaction with sexual experience and ejaculationdate_rangeTime Frame:At 4, 8, 12 weeks after start of study drug administration and LOCFenhanced_encryptionnoSafety Issue:
- Safety datadate_rangeTime Frame:Throughout the studyenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
3