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RECRUITING
NCT06805513
PHASE3

Actual Use Trial of Tadalafil 5 mg

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: Actual Use Trial to Switch Tadalafil 5 mg Tablets From Prescription to Over-the-Counter

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2250

Start Date

2025-01-30

Completion Date

2026-02-28

Last Updated

2025-02-24

Healthy Volunteers

Yes

Interventions

COMBINATION_PRODUCT

Tadalafil 5 mg tablets with a digital tool.

The combination product will be a Drug (Tadalafil 5 mg) and Health Survey Assessment (as a mandatory digital tool). Tadalafil 5 mg will be taken orally, 1 tablet daily to use for treatment of erectile dysfunction. This study will be conducted remotely, via video interaction.

Locations (1)

Pegus

Salt Lake City, Utah, United States