Diabetes Mellitus, Erectile Dysfunction
Conditions
Keywords
Vardenafil, PDE5 inhibitor, Erectile Dysfunction, Diabetes Mellitus, Sexual Dysfunction
Brief summary
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.
Interventions
DRUGLevitra (Vardenafil, BAY38-9456)
BAY 38-9456 10 mg tablet prior to intercourse on demand
DRUGPlacebo
Placebo tablet prior to intercourse on demand
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance) * Diabetes for more than 3 years
Exclusion criteria
* Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose * Spinal cord injury * History of surgical prostatectomy (excluding TURP) * Patients with an HbA1c \> 12% at Visit 1 * Use of nitrates * Use of potent CYP3a4 inhibitors * Severe liver disease * Presence of Peyronie's Disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15 | At 12 weeks after start of study drug administration using data at LOCF to account for dropouts |
Secondary
| Measure | Time frame |
|---|---|
| The IIEF EF domain score | At 4, 8, 12 weeks after start of study drug administration |
| 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)] | At 4, 8, 12 weeks after start of study drug administration and LOCF |
| The Global Assessment Question | At 4, 8, 12 weeks after start of study drug administration and LOCF |
| 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 ejaculation | At 4, 8, 12 weeks after start of study drug administration and LOCF |
| Safety data | Throughout the study |
| Scores of Questions 1 to 15 on the IIEF Questionnaire | At 4, 8, 12 weeks after start of study drug administration and LOCF |
Outcome results
None listed