Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.
Public ClinicalTrials.gov record NCT00655629. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
Study identification
- NCT ID
- NCT00655629
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 339 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2008
- Primary completion
- Jan 31, 2009
- Completion
- Jan 31, 2009
- Last update posted
- Jul 31, 2014
2008 – 2009
United States locations
- U.S. sites
- 21
- U.S. states
- 8
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| East Valley Family Physicians, PLC | Chandler | Arizona | 85224 | — |
| Mesa Family Medical Center | Mesa | Arizona | 85203 | — |
| Desert Clinical Research | Mesa | Arizona | 85213 | — |
| Arizona Research Center, Inc. | Phoenix | Arizona | 85023 | — |
| Tatum Highlands Medical Associates, PLLC | Phoenix | Arizona | 85050 | — |
| Fiel Family & Sports Medicine, PC | Tempe | Arizona | 85283 | — |
| Irvine Center for Clinical Research | Irvine | California | 92618-3603 | — |
| Synergy Clinical Research Center | National City | California | 91950 | — |
| San Diego Uro-Research | San Diego | California | 92103 | — |
| San Diego Clinical Trials | San Diego | California | 92120 | — |
| South Florida Medical Research | Aventura | Florida | 33180 | — |
| Jacksonville Impotence Treatment Center | Jacksonville | Florida | 32223 | — |
| University Clinical Research, Inc. | Pembroke Pines | Florida | 33024 | — |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | — |
| Office of Dr. Bruce Gilbert, MD | Great Neck | New York | 11021 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| The Urology Group | Cincinnati | Ohio | 45212-2787 | — |
| Columbus Urology Research, LLC | Columbus | Ohio | 43220 | — |
| Family Medical Associates | Levittown | Pennsylvania | 19056 | — |
| Pearl Clinical Research | Norristown | Pennsylvania | 19401 | — |
| Office of Dr. Roger Fincher, MD | Spokane | Washington | 99206 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00655629, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2014 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00655629 live on ClinicalTrials.gov.