Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00668018
• Collaborator: (none)
• Enrollment: 887
• Arm: 1
• Duration (Months): 9

Study Details

Study Description

Brief Summary

Assess efficacy of vardenafil within 6 hours after intake

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 887 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Oct 1, 2003
• Actual Study Completion Date: Oct 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456); Vardenafil 10mg orally on demand prior to intercourse

Outcome Measures

Primary Outcome Measures

1. Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake [12 weeks]

Secondary Outcome Measures

1. International Index of Erectile Function [12 weeks]

2. Global Assessment Question (GAQ) [12 weeks]

3. Other diary responses [12 weeks]

4. General Safety [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age: 18 years and older

• Males with erectile dysfunction

• Stable heterosexual relationship

Exclusion Criteria:

• Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months

• Nitrate use

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00668018
• Other Study ID Numbers: 10678
• First Posted: Apr 28, 2008
• Last Update Posted: Dec 23, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Bayer: Male Erectile Dysfunction; Vardenafil
• Additional relevant MeSH terms: Erectile Dysfunction; Vardenafil Dihydrochloride

Study Results

No Results Posted as of Dec 23, 2014