Assess Efficacy in Subjects With Traumatic Spinal Cord Injury (LEMDE)

Bayer

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction; Spinal Cord Injury

Treatments: Drug: Placebo; Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg; Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00667966

2004-005282-37 (EudraCT Number)

11861

Details and patient eligibility

About

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

Enrollment: 45 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men between 18 and 64 years old with stable cord injury (more than 6 months) who had erectile dysfunction according to the National Institutes if Health (NIH) after their traumatic spinal cord injury

Exclusion criteria

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
• Nitrate therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Vardenafil + Placebo

Experimental group

Description:

Subjects received single dose of 10 mg vardenafil followed by 20 mg vardenafil and then crossed over to 10 mg placebo followed by 20 mg placebo.

Treatment:

Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg

Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg

Drug: Placebo

Placebo + Vardenafil

Experimental group

Description:

Subjects received single dose of 10 mg placebo followed by 20 mg placebo and then crossed over to 10 mg vardenafil followed by 20 mg vardenafil.

Treatment:

Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg

Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg

Drug: Placebo