Actual Use Trial to Switch Tadalafil 5 mg Tablets From Prescription to Over-the-Counter
Sanofi
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: Participants will be included in Part II (enrolment phase) if they are: 1. Male or female, 16 years of age or older 2. Living in the US (Since this study will be conducted remotely, it is important to assure that all participants reside in this country.) Participants will be included in Part III (use phase) if they: 1. Are male (sex assigned at birth) 2. Are at least 18 years of age 3. Complete the HSA with a purchase code for Cialis OTC 4. Purchase the study product Exclusion Criteria: Below participants will be excluded from Part II: 1. Participant lives in the sta…
Interventions
- Combination ProductTadalafil 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.
Location
- PegusSalt Lake City, Utah