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Erectile DysfunctionPhase 3NCT06805513

Actual Use Trial of Tadalafil 5 mg

A Phase 3 study testing Tadalafil 5 mg tablets with a digital tool. in people with Erectile Dysfunction, run by Sanofi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Erectile Dysfunction
What is being tested?
Tadalafil 5 mg tablets with a digital tool.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,212 participants
Where
1 siteUnited States
Study dates
30 Jan 2025to 2 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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 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.
  • 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
  • Below participants will be excluded from Part III:
  • 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
  • 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.)
  • Participants who are unwilling to provide contact information
  • Participants who are unwilling or unable to use an eDiary to record the required information
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pegus

    Salt Lake City, Utah, 84101

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
Tadalafil 5 mg tablets with a digital tool.
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tadalafil 5 mg tablets with a digital tool.Combination product

    Also called Cialis 5 mg

    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.

Study groups in NCT06805513
Study groupRoleWhat they receive
Cialis OTCOtherOpen Label Single Arm study in men who have the symptoms of ED and who have an interest in an OTC treatment.
Receives: Combination Product: Tadalafil 5 mg tablets with a digital tool.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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

    Measured: 1 day (completion of the enrollment interview)

Secondary outcomes (8)

  1. 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

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

  2. 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

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

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

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

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

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

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

    Measured: 1 day (completion of the enrollment interview)

  6. The proportion of all participants found to have ask a doctor before use (AADBU) or ask a doctor or pharmacist before use (AADPBU) conditions in the Medical Assessment who also received an AADBU or AADPBU Outcome screen in the HSA.

    Measured: 1 day (completion of the enrollment interview)

  7. The proportion of participants who take 1 tablet (5 mg) on the first dosing occasion.

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

  8. The proportion of dosing occasions in which 2 tablets (10 mg) are not exceeded per dosing occasion.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2025
  2. Study start30 Jan 2025
  3. Primary completion2 Mar 2026
  4. Study completion2 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06805513
Sponsor's protocol ID
AUT16661
Other IDs
AUT16661, U1111-1267-2510
Status last verified
Jul 2026
First submitted
17 Jan 2025
Last updated
13 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tadalafil 5 mg tablets with a digital tool. in people with Erectile Dysfunction, run by Sanofi at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of inter-dosing intervals in which the recommended time between doses is followed (time frame: From the beginning of Use phase to end, at 120 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06805513.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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