BAY38-9456 - Supportive Trial for Spinal Injury

Phase 3

Completed

• Conditions: Spinal Cord Injury; Erectile Dysfunction; Sexual Dysfunction
• Interventions: Drug: Levitra (Vardenafil, BAY38-9456)

• Registration Number: NCT00652262
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study Completion: 2004-11
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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?]

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	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
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
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