Actively Recruiting
Actual Use Trial to Switch Tadalafil 5 mg Tablets From Prescription to Over-the-Counter
Led by Sanofi · Updated on 2025-02-24
2250
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate if men can appropriately select and use tadalafil 5 mg tablets as an over-the-counter (OTC) treatment for erectile dysfunction. The study is an open-label actual use trial enrolling about 2,250 men who have symptoms of erectile dysfunction and are interested in OTC treatment. Approximately 1,000 participants are expected to proceed to the use phase based on their responses to a mandatory health survey assessment. Participants will take tadalafil 5 mg tablets orally, one tablet daily, while using a digital health survey tool. The study is conducted remotely via video interaction over a four-month period. It is designed as a single-arm open-label trial, focusing on real-world use of tadalafil as an OTC medication. During the study, researchers will monitor how well participants follow the recommended dosing intervals, their medical conditions, and any adverse events or care-seeking behaviors related to the use of tadalafil. Participants will complete health surveys, record their dosing and symptoms in electronic diaries, and be monitored for safety throughout the 4-month use phase plus a 30-day follow-up period. The main outcomes include adherence to dosing recommendations and appropriate use based on medical assessments.
CONDITIONS
Brief Title
Actual Use Trial of Tadalafil 5 mg
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male sex assigned at birth
- At least 18 years of age
- Interested in using tadalafil 5 mg as an over-the-counter treatment for erectile dysfunction
- Completion of the mandatory health survey assessment with a purchase code for Cialis OTC
- Purchase of the study product
- Residency in the United States
- Ability to participate remotely via video interaction
You will not qualify if you...
- Living in the state of Massachusetts
- Unable or unwilling to show a current government-issued ID for age and identity verification
- Cannot read, speak, or understand English
- Participated in another health-related market research study, product label study, or clinical trial in the past 12 months
- Previously participated in research about erectile dysfunction medicines
- Participant or household member works for a pharmaceutical company, healthcare practice, market research, advertising company, or PEGUS Research
- Unable to attend the remote Enrollment Interview
- Participant or household member has already participated in this study
- Does not provide verbal permission to video record study interviews
- Not willing or able to use an electronic diary to record study information
- Determined by the principal investigator or Medical Monitor to have safety concerns precluding further participation
- Minors without parent or guardian permission when required
- Participants without corrective lenses during remote interviews when needed
- Participants excluded for specific medical conditions identified in the health survey assessment or medical evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (remote via video interaction)
Duration - 4 months
Participants take one 5 mg tablet of tadalafil daily for erectile dysfunction while using a mandatory digital health survey tool to track their dosing and symptoms.
Remote video interactions throughout the 4-month treatment period
Duration - 1 month
Participants are monitored for safety and adverse events following the treatment period.
Remote follow-up contact during the 30-day post-treatment period
Trial Site Locations
Total: 1 location
1
Pegus
Salt Lake City, Utah, United States, 84101
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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