Actual Use Trial to Switch Tadalafil 5 mg Tablets From Prescription to Over-the-Counter
Abstract
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: Erectile Dysfunction.
Primary outcome: The proportion of inter-dosing intervals in which the recommended time between doses is followed; The proportion of all participants found to have a do not use (DNU) condition in the Medical Assessment who also received a DNU Outcome screen in the Health survey assessment.
Enrollment: 2212 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 2,212 participants or records.
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