BAY38-9456 - Supportive Trial for Spinal Injury

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00652262

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

10.7

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction Sexual Dysfunction Spinal Cord Injury	Drug: Levitra (Vardenafil, BAY38-9456)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2004

Actual Study Completion Date :

Nov 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) 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.

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Levitra (Vardenafil, BAY38-9456)

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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