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NCT05490680
A New Sildenafil Oral Film in Patients With Erectile Dysfunction
Phase 3 trial testing Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg in Erectile Dysfunction in 488 participants. Completed in 9 December 2024.
9 December 2024
Quick facts
| Lead sponsor | IBSA Institut Biochimique SA |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 488 |
| Start date | 26 January 2024 |
| Primary completion | 9 December 2024 |
| Estimated completion | 9 December 2024 |
| Sites | 18 locations across United States |
Drugs / interventions tested
- Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg — full drug profile →
- Placebo
Conditions studied
- Erectile Dysfunction — all drugs for Erectile Dysfunction →
Sponsor
IBSA Institut Biochimique SA — full company profile →
Who can join
18 and older, male only, with Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Orodispersible Films: Current Innovations and Emerging Trends.
Jacob S, Boddu SHS, Bhandare R, Ahmad SS, et al · · 2023 · cited 21× · PMID 38140094 · DOI 10.3390/pharmaceutics15122753
Verify or expand the search:
- PubMed search for NCT05490680
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Erectile Dysfunction
Currently open trials in the same condition.
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- NCT07366970 — Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D? · NA · recruiting
- NCT06960746 — Changing Lifestyle in OSA Males Who Suffer Metabolic Syndrome and Impotence: Is There a Response? · NA · recruiting
- NCT06872866 — The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under · Phase 1 · recruiting
- NCT06805513 — Actual Use Trial of Tadalafil 5 mg · Phase 3 · recruiting
Other IBSA Institut Biochimique SA trials
Trials by the same sponsor.
- NCT06659692 — Pharmacokinetics of FSH and hCG Following Multiple Dose of Gonadotropins-IBSA. · Phase 1 · completed
- NCT06781957 — Pharmacokinetics of FSH and hCG After a Single Subcutaneous Injection of Gonadotropins-IBSA · Phase 1 · completed
- NCT04549116 — Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. · Phase 3 · active not recruiting
- NCT05228184 — Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH) · Phase 4 · terminated
- NCT05171673 — Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants with Minor Soft Tissue Injury · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05490680 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IBSA Institut Biochimique SA
- Last refreshed: 23 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05490680.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing