Actual Use Trial of Tadalafil 5 mg

Last updated: February 21, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

3

Condition

Erectile Dysfunction

Infertility

Impotence

Treatment

Tadalafil 5 mg tablets with a digital tool.

Clinical Study ID

NCT06805513
AUT16661
AUT16661
U1111-1267-2510
  • Ages > 18
  • Male
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

Participants will be included in Part II (enrolment phase) if they are:

  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 toassure that all participants reside in this country.)

Participants will be included in Part III (use phase) if they:

  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

Exclusion

Exclusion Criteria:

Below participants will be excluded from Part II:

  1. 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.)

  2. 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

  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 erectiledysfunction

  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 asa 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 oradvertising 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 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.

  11. 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.

  12. Participant is not willing or able to attend/participate in the Enrollment Interviewremotely

  13. Participant, or someone else in the household, has participated in this study (onlyone 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 whoare not LHL will be screened out

Below participants will be excluded from Part III:

  1. 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

  2. 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.)

  3. Participants who are unwilling to provide contact information

  4. Participants who are unwilling or unable to use an eDiary to record the requiredinformation

  5. 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

Total Participants: 2250
Treatment Group(s): 1
Primary Treatment: Tadalafil 5 mg tablets with a digital tool.
Phase: 3
Study Start date:
January 30, 2025
Estimated Completion Date:
February 28, 2026

Study Description

This will be an open-label 4-month AUT of tadalafil 5 mg tablet in men who are interested in an OTC treatment for erectile dysfunction. The open-label study will enroll approximately 2,250 participants who qualify for treatment based on the data they enter into the HSA of which an estimated 1000 participants will ultimately proceed to the use phase.

Connect with a study center

  • Pegus

    Salt Lake City, Utah 84101
    United States

    Active - Recruiting

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