Actively Recruiting

Phase 3
Age: 18Years +
MALE
Healthy Volunteers
NCT06805513

Actual Use Trial of Tadalafil 5 mg

Led by Sanofi · Updated on 2025-02-24

2250

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Actual Use Trial of Tadalafil 5 mg

Who Can Participate

Age: 18Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, 16 years of age or older
  • Living in the US
  • Male sex assigned at birth
  • At least 18 years of age
  • Complete the Health Survey Assessment with a purchase code for Cialis OTC
  • Purchase the study product
Not Eligible

You will not qualify if you...

  • Living in the state of Massachusetts
  • Unable or unwilling to show current government-issued ID if 18 years or older
  • Cannot read, speak, and understand English
  • Participated in another health-related market research, product label study, or clinical trial in the past 12 months
  • Ever participated in a research study about a medicine for erectile dysfunction
  • Participant or household member works for a pharmaceutical company
  • Participant or household member is a healthcare professional or trained as one
  • Participant or household member employed by a market research or advertising company
  • Participant or household member employed by PEGUS Research
  • Does not have corrective lenses if needed for remote Enrollment Interview
  • Considered a minor by state law without a parent or guardian willing to sign permission
  • Not willing or able to attend or participate in the Enrollment Interview remotely
  • Participant or household member has already participated in this study
  • Does not provide verbal permission to video record study interviews
  • Not low health literacy if required to obtain 30% low health literacy participants
  • Determined to have any do not use (DNU) conditions in the Medical Assessment
  • Does not sign the Informed Consent Document or guardian refusal for minors
  • Unwilling to provide contact information
  • Unwilling or unable to use an electronic diary
  • Principal investigator or Medical Monitor excludes for safety concerns

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Pegus

Salt Lake City, Utah, United States, 84101

Actively Recruiting

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Research Team

T

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Actual Use Trial of Tadalafil 5 mg | DecenTrialz