Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00665496 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Erectile Dysfunction, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 732
- Enrollment target
- 20
- Study locations
NCT00665496: Completed Phase 3 study of Erectile Dysfunction, sponsored by Bayer.
NCT00665496 is a Phase 3 study of Erectile Dysfunction that has completed, run by Bayer. The registered enrollment target is 732 participants, above the 209-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (250% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00665496, a Phase 3 study of Erectile Dysfunction, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 732 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Levitra (Vardenafil, BAY38-9456)
Study Locations (20)
Florida
- - Aventura
- - Jacksonville
- - Pembroke Pines
California
- - Beverly Hills
- - San Bernardino
North Carolina
- - Charlotte
- - Wilmington
Ontario
- - Barrie
- - Toronto
Quebec
- - Montreal
- - Sherbrooke
Arizona
- - Phoenix
Colorado
- - Aurora
Connecticut
- - Trumbull
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 732 participants |
| Start Date | 2003-06 |
| Est. Completion | 2003-11 |
| Phase | Phase 3 |
What the finished NCT00665496 record still lists
NCT00665496 is an interventional study that assigns participants to a tested intervention. The registered 732 participants enrollment target is mid-sized for trials with a published cap, above the 209-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (250% higher).
The record links to 1 condition, with Erectile Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00665496 names 20 study sites across 14 states, led by Florida, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00665496 about?
NCT00665496 is a clinical study titled "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". 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...
What is the current status of trial NCT00665496?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 732 participants. The study started on 2003-06. Estimated completion is 2003-11.
What conditions does trial NCT00665496 study?
This clinical trial studies the following conditions: Erectile Dysfunction.
What interventions are being tested in trial NCT00665496?
The interventions under investigation include: Placebo (DRUG), Levitra (Vardenafil, BAY38-9456) (DRUG).
Who is sponsoring clinical trial NCT00665496?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00665496 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Erectile Dysfunction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00665496's enrollment target sits among peer trials
732 3rd of 33 higher than 31 of 33 other Erectile Dysfunction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Erectile Dysfunction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)
RECRUITING · Phase 3
-
Actual Use Trial of Tadalafil 5 mg
RECRUITING · Phase 3
-
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement
ACTIVE NOT RECRUITING · Phase 3
-
An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
COMPLETED · Phase 3
-
Treatment of Erectile Dysfunction II
COMPLETED · Phase 3
-
Study of Sildenafil Citrate During and After Radiotherapy/Hormone Therapy for Erectile Function Versus Radiotherapy/Hormone Therapy for Prostate Cancer
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06216301 · 734 participants · Phase 3
LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
- NCT07231419 · 734 participants · Phase 3
Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy
- NCT03232918 · 730 participants · Phase 4
Oxytocin and Fetal Heart Rate Changes
- NCT05548283 · 730 participants · Phase 4
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia