BAY38-9456 - Pivotal Trial for Diabetes Patient

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Placebo-controlled, Double-blind, Multi-centre, Parallel Group Study to Investigate the Efficacy and Safety of BAY 38-9456 in Males With Diabetes Suffering From Erectile Dysfunction

Conditions
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Erectile Dysfunction, Diabetes Mellitus

Intervention / Treatment
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* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 3<br> | Drug: Placebo<br>* Placebo tablet prior to intercourse on demand<br>|
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* BAY 38-9456 10 mg tablet prior to intercourse on demand<br>|
| Experimental: Arm 2<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* BAY 38-9456 20 mg tablet prior to intercourse on demand<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vardenafil, PDE5 inhibitor, Erectile Dysfunction, Diabetes Mellitus, Sexual Dysfunction