A New Sildenafil Oral Film in Patients With Erectile Dysfunction
Public ClinicalTrials.gov record NCT05490680. 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
A Multi-center, Prospective, Randomized, Double-blind, Flexible-dose, Placebo-controlled, Parallel Group Clinical Trial of Sildenafil Oral Film 25 mg, 50 mg, 75 mg and 100 mg for the Treatment of Erectile Dysfunction (ED)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase III, prospective, interventional, multi-center, randomized, double-blind, flexible-dose, placebo-controlled, parallel group clinical study required by FDA to demonstrate the efficacy and safety of Sildenafil oral film 25 mg, 50 mg, 75 mg and 100 mg as compared to placebo in approximately 488 men clinically diagnosed with erectile dysfunction (ED).
Study identification
- NCT ID
- NCT05490680
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 488 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
- Jan 26, 2024 (Actual)
- Primary completion
- Dec 9, 2024 (Actual)
- Completion
- Dec 9, 2024 (Actual)
- Last update posted
- Oct 23, 2025
2024
United States locations
- U.S. sites
- 18
- U.S. states
- 9
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| G & L Research LLC. | Foley | Alabama | 36535 | — |
| Medical Affiliated Research Center | Huntsville | Alabama | 35801 | — |
| Arkansas Urology Research Center | Little Rock | Arkansas | 72211 | — |
| Urology Group of Southern California | Los Angeles | California | 90017 | — |
| Tri Valley Urology Medical Group | Murrieta | California | 92562 | — |
| Innovation Medical Group LLC (Endo Care of South Florida) | Fort Lauderdale | Florida | 33316 | — |
| Clintex Research Group | Miami | Florida | 33135 | — |
| Coral Research Clinic | Miami | Florida | 33186 | — |
| Harmony Clinical Research | North Miami Beach | Florida | 33162 | — |
| Innovation Clinical Trials: Medical Reseach Center | Palmetto Bay | Florida | 33157 | — |
| Precision Clinical Research, LLC | Sunrise | Florida | 33351 | — |
| Alliance for Multispecialty Research, LLC | Las Vegas | Nevada | 89119 | — |
| AccuMed Research Associates | Garden City | New York | 11530 | — |
| Rochester Clinical Research, Inc | Rochester | New York | 14609 | — |
| Alliance for Multispeciaty Research, LLC | Knoxville | Tennessee | 37909 | — |
| Mt. Olympus Medical Research Group, LLC | Sugar Land | Texas | 77479 | — |
| Tranquil Clinical and Research Consulting Services, LLC | Webster | Texas | 77598 | — |
| Virginia Urology | Richmond | Virginia | 23235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05490680, 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 Oct 23, 2025 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05490680 live on ClinicalTrials.gov.