Phase
Condition
Erectile Dysfunction
Infertility
Impotence
Treatment
Tadalafil 5 mg tablets with a digital tool.
Clinical Study ID
Ages > 18 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 toassure 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
Exclusion
Exclusion Criteria:
Below participants will be excluded from Part II:
Participant lives in the state of Massachusetts (Massachusetts state law requires anapplication to the State Board of Pharmacy in order to get authorization todistribute the study product to participants who live there.)
Participant 18 years of age or older is unable or unwilling to show a currentgovernment-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 erectiledysfunction
Participant, or someone else in the household works for a pharmaceutical company
Participant, or someone else in the household is a healthcare professional, works asa 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 oradvertising 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 musthave them when the remote Enrollment Interview is conducted (Part II). If they donot, they will not be allowed to participate. This exclusion will be implementedduring the remote Subgroup Identification Interview (SGI) Interview where theparticipants will be re-screened.
Participants who are considered minors, according to the law in the state where theyreside, who do not have a parent or guardian present and willing to electronicallysign permission to allow the minor to participate in the SGI and EnrollmentInterviews. A participant is considered a minor in all states if they are 16-17years of age. Additionally, participants 18 years of age in Alabama or Nebraska, andparticipants 18-20 years of age in Mississippi are also considered minors.
Participant is not willing or able to attend/participate in the Enrollment Interviewremotely
Participant, or someone else in the household, has participated in this study (onlyone 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 whoare 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 weredetermined in the Medical Assessment to have any of the DNU conditions listed on theDFL
Participants who do not sign the Informed Consent Document (ICD) or if the parent orguardian of a minor does not sign the ICD. (Parent/guardian refusal applies to maleswho are 18 years of age or older but considered minors in the state where theyreside.)
Participants who are unwilling to provide contact information
Participants who are unwilling or unable to use an eDiary to record the requiredinformation
Participants who the principal investigator or the Medical Monitor believes shouldbe excluded or removed from further participation in the Use Phase due to safetyconcerns
Study Design
Study Description
Connect with a study center
Pegus
Salt Lake City, Utah 84101
United StatesActive - Recruiting
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