BAY38-9456 - Supportive Trial for Spinal Injury

Study Overview
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Brief Summary
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BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be improved by uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not sufficiently effective

Official Title
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An Open, Multi-centre, Flexible Dose Uptitration Study to Investigate the Efficacy and Safety of Vardenafil 10 mg and 20 mg in Males With Spinal Cord Injury Suffering From Erectile Dysfunction

Conditions
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Erectile Dysfunction, Sexual Dysfunction, Spinal Cord Injury

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male with erectile dysfunction according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance), solely as a result of a traumatic injury to the spinal cord (suffering more than 6 months ago) Patients answering yes to the question regarding the presence of residual erectile function over the past 6 months [At home over the past 6 months, have you experienced at least some enlargement of your penis in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?] Exclusion Criteria: History of diabetes mellitus Patients who are taking nitrates or nitric oxide donors Patients who have experienced no enlargement of penis with PDE5 inhibitor and/or who have withdrew the use of PDE5 inhibitor due to ADRs

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* Patients received BAY 38-9456 10 mg for the first 4 weeks of the treatment period, and then went on to receive 10 mg or 20 mg for the following 8 weeks.<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, Spinal cord injury