Could cialis go over the counter? new study tests safe access without a prescription

NCT ID NCT06805513

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study is testing whether men can safely use tadalafil 5 mg (Cialis) for erectile dysfunction without a prescription. Participants will use a digital health survey to check if the drug is right for them before buying it. The goal is to see if people follow dosing instructions and avoid using the drug when they have certain health conditions. If successful, this could lead to Cialis being sold over the counter.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tadalafil 5 mg (Cialis)
What this could lead to
If successful, this could make Cialis available over the counter, giving men easier access to treatment for erectile dysfunction without needing a doctor's visit.
What could go wrong
This is a real-world use study, not a test of effectiveness. Some men may still misuse the drug or ignore safety warnings, and the digital tool may not catch all risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,212 people

The number who actually took part.

Started

Jan 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 to assure 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 Criteria: Below participants will be excluded from Part II: 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 Below participants will be excluded from Part III: 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Pegus

    Salt Lake City, Utah, 84101, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.