Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by IBSA Institut Biochimique. The registered enrollment target is 488 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05490680
The ClinicalTrials.gov registry entry for NCT05490680 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 488 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IBSA Institut Biochimique, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05490680 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.