Study Completed

Erectile Dysfunction, Sexual Dysfunction, Spinal Cord Injury

Bayer Identifier:

100608

ClinicalTrials.gov Identifier:

NCT00652262

EudraCT Number:

Not Available

EU CT Number:

Not Available

BAY38-9456 - Supportive trial for spinal injury

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

20 - 64 Years

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

Trial summary

Enrollment Goal

Trial Dates

March 2004 - November 2004

Phase

Phase 3

Could I Receive a placebo

Products

Levitra (Vardenafil, BAY38-9456)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Beppu, 874-0937, Japan
Completed		Iizuka, 820-0053, Japan
Completed		Nagoya, 455-8530, Japan

Primary Outcome

The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
Time Frame:
At 12 weeks after start of study drug administration using data at LOCF to account for dropouts
Safety Issue:
no

Secondary Outcome

The Global Assessment Question
Time Frame:
At 4, 8, 12 weeks after start of study drug administration and LOCF
Safety Issue:
no
The IIEF EF domain score
Time Frame:
At 4, 8, 12 weeks after start of study drug administration
Safety Issue:
no
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)]
Time Frame:
At 4, 8, 12 weeks after start of study drug administration and LOCF
Safety Issue:
no
Scores of Questions 1 to 15 on the IIEF Questionnaire
Time Frame:
At 4, 8, 12 weeks after start of study drug administration and LOCF
Safety Issue:
no
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
Time Frame:
At 4, 8, 12 weeks after start of study drug administration and LOCF
Safety Issue:
no
Safety data
Time Frame:
Throughout the study
Safety Issue:
yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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