BAY38-9456 - Supportive Trial for Spinal Injury

Bayer

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction; Sexual Dysfunction; Spinal Cord Injury

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652262

100608

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Male

Ages: 20 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)