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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 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.

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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.

Conditions Studied

Interventions

  • COMBINATION_PRODUCT Tadalafil 5 mg tablets with a digital tool.

Study Locations (1)

Utah

  • Pegus - Salt Lake City

Trial Details

FieldValue
Enrollment Target 2,250 participants
Start Date 2025-01-30
Est. Completion 2026-02-28
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT06805513

The ClinicalTrials.gov registry entry for NCT06805513 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 2,250 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 163-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (1280% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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