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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2,212
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.
Pegus
Salt Lake City, Utah, United States
The proportion of inter-dosing intervals in which the recommended time between doses is followed
Dosing intervals from participant dosing occasions as recorded in the eDiary population will be used to calculate this endpoint.
Time frame: From the beginning of Use phase to end, at 120 days.
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
Time frame: 1 day (completion of the enrollment interview)
Descriptive analysis of care-seeking behaviors in the case of heart attack, priapism, allergic reaction, sudden vision or hearing loss, where the participant took Cialis OTC within the 72 hour time period prior to the event
Time frame: From the beginning of Use phase to end, at 120 days.
Descriptive analysis of care-seeking behaviors associated with dizziness or feeling faint which does not get better after sitting or lying down, and where the participant took Cialis OTC within the 72 hour time period prior to the event
Time frame: From the beginning of Use phase to end, at 120 days.
Descriptive analysis of serious adverse event (SAE)s and adverse event of special interest (AESI)s.
Time frame: From the beginning of Use phase to end, at 150 days (120 days study period + 30 day follow-up period).
Descriptive analysis of dosing behavior patterns among those who do not comply with the recommended dosing interval.
Time frame: From the beginning of Use phase to end, at 120 days.
The proportion of participants ever prescribed a nitrate medicine who also received a DNU-Nitrate Outcome screen in the HSA.
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Time frame: 1 day (completion of the enrollment interview)
The proportion of all participants found to have ask a doctor before use (AADBU) or ask a doctor or pharmacist before use (AADPBU) conditions in the Medical Assessment who also received an AADBU or AADPBU Outcome screen in the HSA.
Time frame: 1 day (completion of the enrollment interview)
The proportion of participants who take 1 tablet (5 mg) on the first dosing occasion.
Time frame: From the beginning of Use phase to end, at 120 days.
The proportion of dosing occasions in which 2 tablets (10 mg) are not exceeded per dosing occasion.
Time frame: From the beginning of Use phase to end, at 120 days.