Actual Use Trial of Tadalafil 5 mg

NCT06805513 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: AUT16661U1111-1267-2510
• Study Type: interventional
• Target: 2,250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (2)

• The proportion of inter-dosing intervals in which the recommended time between doses is followed

  Dosing intervals from participant dosing occasions as recorded in the eDiary population will be used to calculate this endpoint.

  From the beginning of Use phase to end, at 120 days.

• The proportion of all participants found to have a do not use (DNU) condition in the Medical Assessment who also received a DNU Outcome screen in the Health survey assessment

  1 day (completion of the enrollment interview)

Secondary Outcomes (8)

• Descriptive analysis of care-seeking behaviors in the case of heart attack, priapism, allergic reaction, sudden vision or hearing loss, where the participant took Cialis OTC within the 72 hour time period prior to the event

  From the beginning of Use phase to end, at 120 days.

• Descriptive analysis of care-seeking behaviors associated with dizziness or feeling faint which does not get better after sitting or lying down, and where the participant took Cialis OTC within the 72 hour time period prior to the event

  From the beginning of Use phase to end, at 120 days.

• Descriptive analysis of serious adverse event (SAE)s and adverse event of special interest (AESI)s.

  From the beginning of Use phase to end, at 150 days (120 days study period + 30 day follow-up period).

• Descriptive analysis of dosing behavior patterns among those who do not comply with the recommended dosing interval.

  From the beginning of Use phase to end, at 120 days.

• The proportion of participants ever prescribed a nitrate medicine who also received a DNU-Nitrate Outcome screen in the HSA.

  1 day (completion of the enrollment interview)

Study Arms (1)

Cialis OTC

OTHER

Open Label Single Arm study in men who have the symptoms of ED and who have an interest in an OTC treatment.

Combination Product: Tadalafil 5 mg tablets with a digital tool.

Interventions

Tadalafil 5 mg tablets with a digital tool. COMBINATION_PRODUCT

The combination product will be a Drug (Tadalafil 5 mg) and Health Survey Assessment (as a mandatory digital tool). Tadalafil 5 mg will be taken orally, 1 tablet daily to use for treatment of erectile dysfunction. This study will be conducted remotely, via video interaction.

Also known as: Cialis 5 mg

Cialis OTC

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Pegus

Salt Lake City, Utah, 84101, United States

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

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

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 3, 2025
• Study Start: January 30, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)