Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00658177
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 463
• Arms: 2
• Duration (Months): 8

Study Details

Study Description

Brief Summary

Study to investigate the efficacy and safety of Vardenafil

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 463 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects
• Study Start Date: Jun 1, 2003
• Actual Study Completion Date: Feb 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456); 20mg to be taken 1 h prior to sexual intercourse
Placebo Comparator: Arm 2	Drug: Placebo; Matching placebo

Outcome Measures

Primary Outcome Measures

1. Sexual Encounter Profile Question 2 [12 weeks]

Secondary Outcome Measures

1. Sexual Encounter Profile Question 3 [12 weeks]

2. Internation Index of Erectile Function-Erectile Function domain [12 weeks]

3. Safety and tolerability [12 weeks]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

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

• History of unresponsiveness to sildenafil

• 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

• Other exclusion criteria apply according to the US Product Information

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bayer
• GlaxoSmithKline

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00658177
• Other Study ID Numbers: 100497
• First Posted: Apr 14, 2008
• Last Update Posted: Dec 2, 2014
• Last Verified: Dec 1, 2014

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

Study Results

No Results Posted as of Dec 2, 2014