RECRUITING

Actual Use Trial of Tadalafil 5 mg

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Actual Use Trial to Switch Tadalafil 5 mg Tablets From Prescription to Over-the-Counter

Quick Facts

Study Start:2025-01-30

Study Completion:2026-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06805513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female, 16 years of age or older 2. Living in the US (Since this study will be conducted remotely, it is important to assure that all participants reside in this country.) 1. Are male (sex assigned at birth) 2. Are at least 18 years of age 3. Complete the HSA with a purchase code for Cialis OTC 4. Purchase the study product	1. 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.) 2. 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 3. Participant cannot read, speak, and understand English 4. Participant has participated in another health-related market research study, product label study, or clinical trial in the past 12 months 5. Participant has ever participated in a research study about a medicine for erectile dysfunction 6. Participant, or someone else in the household works for a pharmaceutical company 7. 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 8. Participant, or someone else in the household is employed by a market research or advertising company 9. Participant or someone else in the household is employed by PEGUS Research 10. 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. 11. 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. 12. Participant is not willing or able to attend/participate in the Enrollment Interview remotely 13. Participant, or someone else in the household, has participated in this study (only one member of each household will be allowed to participate) 14. Participant does not provide verbal permission to video record study interviews 15. If necessary to obtain approximately 30% low health literacy (LHL), participants who are not LHL will be screened out 1. 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 2. 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.) 3. Participants who are unwilling to provide contact information 4. Participants who are unwilling or unable to use an eDiary to record the required information 5. 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

Inclusion Criteria

Exclusion Criteria

1. Male or female, 16 years of age or older
2. Living in the US (Since this study will be conducted remotely, it is important to assure that all participants reside in this country.)
1. Are male (sex assigned at birth)
2. Are at least 18 years of age
3. Complete the HSA with a purchase code for Cialis OTC
4. Purchase the study product

1. 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.)
2. 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
3. Participant cannot read, speak, and understand English
4. Participant has participated in another health-related market research study, product label study, or clinical trial in the past 12 months
5. Participant has ever participated in a research study about a medicine for erectile dysfunction
6. Participant, or someone else in the household works for a pharmaceutical company
7. 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
8. Participant, or someone else in the household is employed by a market research or advertising company
9. Participant or someone else in the household is employed by PEGUS Research
10. 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.
11. 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.
12. Participant is not willing or able to attend/participate in the Enrollment Interview remotely
13. Participant, or someone else in the household, has participated in this study (only one member of each household will be allowed to participate)
14. Participant does not provide verbal permission to video record study interviews
15. If necessary to obtain approximately 30% low health literacy (LHL), participants who are not LHL will be screened out
1. 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
2. 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.)
3. Participants who are unwilling to provide contact information
4. Participants who are unwilling or unable to use an eDiary to record the required information
5. 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

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610

Contact-US@sanofi.com

Study Locations (Sites)

Pegus

Salt Lake City, Utah, 84101

United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-30

Study Completion Date2026-02-28

Study Record Updates

Study Start Date2025-01-30

Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

Erectile Dysfunction