Assess Efficacy in Subjects With Traumatic Spinal Cord Injury (LEMDE)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00667966
First received: April 24, 2008
Last updated: June 29, 2009
Last verified: June 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Assess efficacy of Vardenafil in patients with traumatic spinal cord injury
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction Spinal Cord Injuries |
Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Double-Blind, Cross-Over, Placebo Controlled Pilot Study to Characterize the Profile of Those Patients With Traumatic Spinal Cord Injury Diagnosed by Electrophysiological, Urodynamic and Clinical (ASIA Group) Assessment Who May Respond to Vardenafil |
Resource links provided by NLM:
Drug Information available for:
Vardenafil
Vardenafil hydrochloride
Vardenafil dihydrochloride
Vardenafil hydrochloride trihydrate
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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 [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of erection [ Time Frame: 4 days ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 51 |
| Study Start Date: | July 2005 |
| Study Completion Date: | February 2007 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil taken orally 1 hour prior to sexual intercourse in cross-over design with placebo
|
| Placebo Comparator: Arm 2 |
Drug: Placebo
Placebo in cross-over design
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00667966 History of Changes |
| Other Study ID Numbers: | 11861, EudraCT No: 2004-005282-37 |
| Study First Received: | April 24, 2008 |
| Last Updated: | June 29, 2009 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Bayer:
|
Spinal cord injury Urodynamic Erectile dysfunction Vardenafil |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Erectile Dysfunction Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders |
Mental Disorders Vardenafil Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013