Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury

Erectile Dysfunction Clinical Trial

Official title:

A Rand, db, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Plac in Subjects With ED Solely Secondary to Traumatic Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654680
• Other study ID #: 10473
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2008
• Last updated: September 26, 2013
• Start date: October 2002
• Est. completion date: January 2004

Study information

• Verified date: September 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Investigate efficacy and safety of Vardenafil in patients with spinal cord injury

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males =18 years with erectile dysfunction (ED) solely as a result of traumatic spinal cord injury (SCI) for =6 months with demonstrated 50% failure in intercourse attempts during the 4-week run-in period.

• Stable heterosexual relationship for at least 1 month.

Exclusion Criteria:

• Subjects with unstable medical or psychiatric conditions or using prohibited concomitant medications

• Primary hypoactive sexual desire

• History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month

• Nitrate therapy

• Other exclusion criteria apply according to US Product Information or Summary of Product Characteristics

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Spinal Cord Injuries

Intervention

Drug:
• Vardenafil (Levitra, BAY38-9456)
5mg, 10mg or 20mg taken 1 hour prior to sexual intercourse
• Placebo
Matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Index of Erectile Function-Erectile Function domain		12 weeks	No
Secondary	Sexual Encounter Profile Question 2		12 weeks	No
Secondary	Sexual Encounter Profile Question 3		12 weeks	No
Secondary	Other diary based variables		12 weeks	No
Secondary	Safety and tolerability		12 weeks	Yes

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