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

Erectile Dysfunction Clinical Trial

Official title:

A Randomized, Double Blind, Double Dummy, Parallel Group, Multi-center 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665496
• Other study ID #: 100492
• Secondary ID: ONTIME
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2008
• Last updated: December 15, 2014
• Start date: June 2003
• Est. completion date: November 2003

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 732
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg and 20 mg orally once a day as needed
• Placebo
Matching Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Netherlands,  Norway,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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	No
Secondary	- 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	No
Secondary	- 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	No
Secondary	- 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	No
Secondary	- Other diary questions		among the first four doses	No
Secondary	- Safety and tolerability		within the study duration	Yes

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