Assess Efficacy in Subjects With Traumatic Spinal Cord Injury

Double-blind, Cross-over, Placebo Controlled Pilot Study to Characterize the Profile of Those Patients With Spinal Cord Injury Diagnosed by Electrophysiological, Urodynamic and Clinical (ASIA Group) Assessment Who May Respond to Vardenafil Treatment. (LEMDE)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00667966

Acronym

LEMDE

Enrollment

Registered

2008-04-28

Start date

2005-07-31

Completion date

2007-02-28

Last updated

2015-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Spinal Cord Injury

Keywords

Spinal cord injury, Urodynamic, Erectile dysfunction, Vardenafil

Brief summary

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

Interventions

DRUGVardenafil (Levitra, BAY 38-9456), 10 mg

10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.

DRUGPlacebo

10/20 mg placebo in sequence in respective arm

DRUGVardenafil (Levitra, BAY 38-9456), 20 mg

20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Characteristics of responders and non responder with respect to the electrophysiological (skin sympathetic response, bulbocavernosus reflex and somatosensory and pudendal evoked potential), urodynamical and clinical (ASIA group) tests	4 treatment days	Responders are defined as subjects with rigidity ≥ 60% in the base measured with RigiScan during at least 5 minutes after withdrawing the vibrator and/or finishing manual stimulation.

Secondary

Measure	Time frame
Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 10 mg dose of vardenafil or placebo	4 treatment days
Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 20 mg dose of vardenafil or placebo	4 treatment days
Number of participants with adverse events	Approximately 4 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026