BAY38-9456 - Supportive Trial for Spinal Injury

Condition(s) targeted: Erectile Dysfunction; Sexual Dysfunction; Spinal Cord Injury

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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: 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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15

Secondary outcome:

The Global Assessment Question

The IIEF EF domain score

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)]

Scores of Questions 1 to 15 on the IIEF Questionnaire

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

Safety data

Minimum age: 20 Years. Maximum age: 64 Years. Gender(s): Male.

Criteria:

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

Nagoya, Aichi 455-8530, Japan

Iizuka, Fukuoka 820-0053, Japan

Beppu, Oita 874-0937, Japan

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Starting date: March 2004
Ending date: November 2004
Last updated: April 1, 2008