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Actual Use Trial of Tadalafil 5 mg

NCT06805513 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2250

Last updated 2025-02-24

No results posted yet for this 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.

Conditions

Interventions

COMBINATION_PRODUCT

Tadalafil 5 mg tablets with a digital tool.

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-30
Primary Completion
2026-01-31
Completion
2026-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06805513 on ClinicalTrials.gov