A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction

Phase 3

Completed

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

• Registration Number: NCT00665496
• Lead Sponsor: Bayer

Brief Summary

This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study Completion: 2003-11
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 732

Inclusion Criteria

• Males with ED for more than 6 months according to the NIH Consensus statement(inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
• Heterosexual relationship
• 18 years and older

Exclusion Criteria

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life threatening arrhythmia within the prior 6 months
• Nitrates or nitric oxide donors use
• Other exclusion criteria according to the US Product Information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3)	First four doses with successful intercourse

Secondary Outcome Measures

Name	Time	Method
- Other diary questions	among the first four doses
- Safety and tolerability	within the study duration
- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration as measured by Sexual Encounter Profile Question 2 (SEP 2).	among the first four doses
- The erectile function (EF) domain score of the International Index of Erectile Function (IIEF) calculated as the sum of scores from Questions 1-5 and 15 at Week 4 as well as all other IIEF factor subscores.	among the first four doses
- Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration.	among the first four doses