NCT06805513

Actual Use Trial of Tadalafil 5 mg

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,250 (estimated)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This will be an open-label 4-month AUT of tadalafil 5 mg tablet in men who are interested in an OTC treatment for erectile dysfunction. The open-label study will enroll approximately 2,250 participants who qualify for treatment based on the data they enter into the HSA of which an estimated 1000 participants will ultimately proceed to the use phase.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-30
• Primary completion: 2026-01-31
• Completion: 2026-02-28
• First posted: 2025-02-03
• Last updated: 2025-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study