Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

Phase 3

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Levitra (Vardenafil, BAY38-9456); Drug: Tadalafil

• Registration Number: NCT00668109
• Lead Sponsor: Bayer

Brief Summary

Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-27
• Study First Posted: 2008-04-28
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 614

Inclusion Criteria

• Age: 18 years and older- Males with erectile dysfunction- Stable heterosexual relationship- Medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia

Exclusion Criteria

• Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use- Other exclusion criteria apply according to Summary of Product Characteristics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Levitra (Vardenafil, BAY38-9456)	-
Arm 2	Tadalafil	-

Primary Outcome Measures

Name	Time	Method
Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group	4 weeks

Secondary Outcome Measures

Name	Time	Method
Hardness of erection	4 weeks
Sexual encounter profile question 2	4 weeks
Other diary based variables	4 weeks
Safety and tolerability	4 weeks