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Recruiting Phase 3 NCT06805513

Actual Use Trial of Tadalafil 5 mg

Trial Parameters

Condition Erectile Dysfunction
Sponsor Sanofi
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 2,250
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2025-01-30
Completion 2026-01-31
Interventions
Tadalafil 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.

Eligibility Criteria

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 state of Massachusetts (Massachusetts state law requires an application to the State Board of Pharmacy in order to get authorization to distribute the study product to participants who live there.) 2. Participant 18 years of age or older is unable or unwilling to show a current government-issued identification (ID) in order to verify identity and age 3. Participant cannot read, speak, and understand English

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