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NCT06805513 · ClinicalTrials.gov registry record · Phase 3
Actual Use Trial of Tadalafil 5 mg
A Phase 3 study of Erectile Dysfunction, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 2,250
- Enrollment target
- 1
- Study location
NCT06805513: Recruiting Phase 3 study of Erectile Dysfunction, sponsored by Sanofi.
NCT06805513 is a Phase 3 study of Erectile Dysfunction that is actively recruiting participants, run by Sanofi. The registered enrollment target is 2,250 participants, above the 163-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (1280% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06805513, a Phase 3 study of Erectile Dysfunction, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,250 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Dosing intervals from participant dosing occasions as recorded in the eDiary population will be used to calculate this endpoint.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Tadalafil 5 mg tablets with a digital tool.
Study Locations (1)
Utah
- Pegus - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,250 participants |
| Start Date | 2025-01-30 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 3 |
What NCT06805513 shows while recruiting
NCT06805513 is an interventional study that assigns participants to a tested intervention. Its 2,250 participants enrollment target places it among the larger protocols in the corpus, above the 163-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (1280% higher).
The record links to 1 condition, with Erectile Dysfunction appearing as the primary indexed condition, and to 1 intervention - of which Tadalafil 5 mg tablets with a digital tool. is the first listed.
NCT06805513 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT06805513 about?
NCT06805513 is a clinical study titled "Actual Use Trial of Tadalafil 5 mg". 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.
What is the current status of trial NCT06805513?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 2,250 participants. The study started on 2025-01-30. Estimated completion is 2026-02-28.
What conditions does trial NCT06805513 study?
This clinical trial studies the following conditions: Erectile Dysfunction.
What interventions are being tested in trial NCT06805513?
The interventions under investigation include: Tadalafil 5 mg tablets with a digital tool. (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06805513?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06805513 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Erectile Dysfunction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06805513's enrollment target sits among peer trials
2,250 1st of 33 higher than 33 of 33 other Erectile Dysfunction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Erectile Dysfunction 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.
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