clinical trial · NCT06805513
Actual Use Trial of Tadalafil 5 mg
Erectile DysfunctionTadalafil 5 mg tablets with a digital tool.
brief 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.
started
Jan 30, 2025
primary completion
Mar 2, 2026
completion
Apr 2, 2026
last updated
Jul 13, 2026
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.
official title
Actual Use Trial to Switch Tadalafil 5 mg Tablets From Prescription to Over-the-Counter
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol