Actual Use Trial of Tadalafil 5 mg

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Sanofi
Study ID
NCT06805513
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Erectile Dysfunction

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Tadalafil 5 mg tablets with a digital tool. — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
Jan 30, 2025
Status verified
Feb 2025
Primary completion
Jan 31, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
2,250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Cialis OTC
    Open Label Single Arm study in men who have the symptoms of ED and who have an interest in an OTC treatment.

Primary Outcome Measure

The proportion of inter-dosing intervals in which the recommended time between doses is followed [ Time Frame: From the beginning of Use phase to end, at 120 days. ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
PegusSalt Lake CityUtah84101
Russell D Bradford, MD
[email protected]
801-487-9899

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By research site
Pegus· Salt Lake City, UT

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