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NCT06805513
Actual Use Trial of Tadalafil 5 mg
Phase 3 trial testing Tadalafil 5 mg tablets with a digital tool. in Erectile Dysfunction in 2,250 participants. Currently enrolling.
31 January 2026
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2,250 |
| Start date | 30 January 2025 |
| Primary completion | 31 January 2026 |
| Estimated completion | 28 February 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Tadalafil 5 mg tablets with a digital tool.
Conditions studied
- Erectile Dysfunction — all drugs for Erectile Dysfunction →
Sponsor
Sanofi — 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
The purpose of this actual use trial (AUT) is to evaluate if participants can appropriately select and use the study product \[Cialis over the counter (OTC)\] using the labeling and the mandatory health survey assessment (HSA) for duration of 4-months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06805513
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Sanofi trials
Trials by the same sponsor.
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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 NCT06805513 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 24 February 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/NCT06805513.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing