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NCT05490680 · ClinicalTrials.gov registry record · Phase 3
A New Sildenafil Oral Film in Patients With Erectile Dysfunction
A Phase 3 study, sponsored by IBSA Institut Biochimique.
- Completed
- Registry status
- Phase 3
- Development phase
- 488
- Enrollment target
NCT05490680: Completed Phase 3 study, sponsored by IBSA Institut Biochimique.
NCT05490680 is a Phase 3 study that has completed, run by IBSA Institut Biochimique. The registered enrollment target is 488 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05490680, a Phase 3 study, has completed, sponsored by IBSA Institut Biochimique.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 488 participants
- Enrollment target
Study Summary
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).
Primary Outcome
Safety of Sildenafil doses versus placebo, i.e., the proportion of subjects with at least one Treatment Emergent Adverse Events (TEAEs) of Special Interest ("Headache" or "Dizziness")
Interventions
- DRUG Placebo
- DRUG Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2024-01-26 |
| Est. Completion | 2024-12-09 |
| Phase | Phase 3 |
What the finished NCT05490680 record still lists
NCT05490680 is an interventional study that assigns participants to a tested intervention. The registered 488 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05490680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05490680 about?
NCT05490680 is a clinical study titled "A New Sildenafil Oral Film in Patients With Erectile Dysfunction". 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 approxima...
What is the current status of trial NCT05490680?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 488 participants. The study started on 2024-01-26. Estimated completion is 2024-12-09.
What interventions are being tested in trial NCT05490680?
The interventions under investigation include: Placebo (DRUG), Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg (DRUG).
Who is sponsoring clinical trial NCT05490680?
This trial is sponsored by IBSA Institut Biochimique, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05490680's enrollment target sits among peer trials
488 784th of 2000 higher than 1,215 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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