BAY38-9456 - Pivotal Trial for Diabetes Patient
Phase 3
Completed
- Conditions
- Diabetes MellitusErectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00678704
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 790
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 3 Placebo - Arm 1 Levitra (Vardenafil, BAY38-9456) - Arm 2 Levitra (Vardenafil, BAY38-9456) -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The Global Assessment Question At 4, 8, 12 weeks after start of study drug administration and LOCF 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 Scores of Questions 1 to 15 on the IIEF Questionnaire 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