Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00661297
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 523
• Arms: 2
• Duration (Months): 7

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: 523 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction
• Study Start Date: Jun 1, 2003
• Actual Study Completion Date: Jan 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456); 10 mg Vardenafil to be taken 1 h prior to sexual attempt
Placebo Comparator: Arm 2	Drug: Placebo; Matching placebo

Outcome Measures

Primary Outcome Measures

1. Sexual Encounter Profile question 2 (SEP 2) [12 weeks]

Secondary Outcome Measures

1. Sexual Encounter Profile question 3 (SEP 3) [12 weeks]

2. International Index of Erectile Function (IIEF) - EF (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:

• Heterosexual males

• /= 18 years old with ED for more than six months

• Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation

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 Summary of Product Characteristics

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: NCT00661297
• Other Study ID Numbers: 100536
• First Posted: Apr 18, 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