Actual Use Trial of Tadalafil 5 mg

Recruiting Phase 3 Interventional Study
Erectile Dysfunction
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,250 (estimated)
Sponsor
Sanofi · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 i…
Contacts

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

800-633-1610

Contact-US@sanofi.com

CONTACT