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 - Tabular View

Tracking Information

First Received Date ^ICMJE

April 23, 2008

Last Updated Date

June 12, 2009

Start Date ^ICMJE

June 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

- 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) [ Time Frame: First four doses with successful intercourse ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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) [ Time Frame: First four doses with successful intercourse ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00665496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- 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). [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- 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. [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration. [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- Other diary questions [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: within the study duration ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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). [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
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. [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration. [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
Other diary questions [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: within the study duration ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Erectile Dysfunction

Intervention ^ICMJE

Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

870

Completion Date

November 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00665496

Responsible Party

Therapeutic Area Head, Bayer Healthcare AG

Study ID Numbers ^ICMJE

100492, ONTIME

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP