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

Completed · Phase 3 · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

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.

Key facts

Study ID

NCT00665496

Run by

Bayer

People needed

732

Starts

2003-06-01

Expected to finish

2003-11-01

Last updated by the study team

2014-12-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — San Bernardino, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Aventura, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Lawrenceville, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Calgary, Alberta, Canada
• Study site — Winnipeg, Manitoba, Canada
• Study site — Saint John, New Brunswick, Canada
• Study site — Kentville, Nova Scotia, Canada
• Study site — Barrie, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Sherbrooke, Quebec, Canada
• Study site — Carpentras, France
• Study site — Lille, France
• Study site — Lyon, France
• Study site — Lyon, France
• Study site — Marseille, France
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.