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NCT00660998 Clinical Trial

Evaluation of Efficacy and Safety of Vardenafil in Patients With Erectile Dysfunction and Type 1 Diabetes

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 Men With Diabetes Mellitus Type 1 and Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00660998
Other study ID # 100540
Secondary ID
Status Completed
Phase Phase 4
First received April 15, 2008
Last updated December 10, 2014
Start date February 2003
Est. completion date January 2004

Study information
Verified date December 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction

Recruitment information / eligibility
Status Completed
Enrollment 318
Est. completion date January 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,

- Diabetes type 1

- Stable sexual relationship for > 6 month.

Exclusion Criteria:

- Primary hypoactive sexual desire

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

- Nitrate therapy

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

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Outcome
Type Measure Description Time frame Safety issue
Primary Sexual Encounter Profile Question 2 12 weeks No
Primary Sexual Encounter Profile Question 3 12 weeks No
Secondary International Index of Erectile Function - Erectile Function Domain 12 weeks No
Secondary Safety and Tolerability 12 weeks Yes
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Completed NCT01037218 - Treatment of Erectile Dysfunction II Phase 3
Completed NCT01037244 - Treatment of Erectile Dysfunction I Phase 3
Recruiting NCT00313898 - Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males Phase 4
Completed NCT00421083 - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury Phase 3
Completed NCT00667979 - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse Phase 4
Completed NCT00663728 - Assessment of Duration of Erection With Vardenafil 10 mg Phase 4

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