Actual Use Trial of Tadalafil 5 mg

Completed · Phase 3

Conditions studied: Erectile Dysfunction

In brief

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 facts

Study ID: NCT06805513
Run by: Sanofi
People needed: 2212
Starts: 2025-01-30
Expected to finish: 2026-04-02
Last updated by the study team: 2026-07-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

Below participants will be excluded from Part II:
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.)
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
Participant cannot read, speak, and understand English
Participant has participated in another health-related market research study, product label study, or clinical trial in the past 12 months
Participant has ever participated in a research study about a medicine for erectile dysfunction
Participant, or someone else in the household works for a pharmaceutical company
Participant, or someone else in the household is a healthcare professional, works as a part of a health care practice, or has been trained as a healthcare professional
Participant, or someone else in the household is employed by a market research or advertising company
Participant or someone else in the household is employed by PEGUS Research
Participants will be told that if they need corrective lenses to read, they must have them when the remote Enrollment Interview is conducted (Part II). If they do not, they will not be allowed to participate. This exclusion will be implemented during the remote Subgroup Identification Interview (SGI) Interview where the participants will be re-screened.
Participants who are considered minors, according to the law in the state where they reside, who do not have a parent or guardian present and willing to electronically sign permission to allow the minor to participate in the SGI and Enrollment Interviews. A participant is considered a minor in all states if they are 16-17 years of age. Additionally, participants 18 years of age in Alabama or Nebraska, and participants 18-20 years of age in Mississippi are also considered minors.
Participant is not willing or able to attend/participate in the Enrollment Interview remotely
Participant, or someone else in the household, has participated in this study (only one member of each household will be allowed to participate)
Participant does not provide verbal permission to video record study interviews
If necessary to obtain approximately 30% low health literacy (LHL), participants who are not LHL will be screened out
Below participants will be excluded from Part III:
Participants who were not excluded for DNU conditions in the HSA, but were determined in the Medical Assessment to have any of the DNU conditions listed on the DFL
Participants who do not sign the Informed Consent Document (ICD) or if the parent or guardian of a minor does not sign the ICD. (Parent/guardian refusal applies to males who are 18 years of age or older but considered minors in the state where they reside.)
Participants who are unwilling to provide contact information
Participants who are unwilling or unable to use an eDiary to record the required information
Participants who the principal investigator or the Medical Monitor believes should be excluded or removed from further participation in the Use Phase due to safety concerns

Where it is running

Pegus — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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