Actual Use Trial to Switch Tadalafil 5 mg Tablets From Prescription to Over-the-Counter
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:
⁃ Participants will be included in Part II (enrolment phase) if they are:
• Male or female, 16 years of age or older
• 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:
• Are male (sex assigned at birth)
• Are at least 18 years of age
• Complete the HSA with a purchase code for Cialis OTC
• Purchase the study product
Locations
United States
Utah
Pegus
RECRUITING
Salt Lake City
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-01-30
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 2250
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Sanofi