Postmarketing Surveillance Study: A Randomized, Open-Label, 3-Month Interventional Study of Tadalafil Effectiveness (2.5 mg and 5 mg) and Long-Term Safety Administered Once Daily in Chinese Men With Erectile Dysfunction
Abstract
The purpose of this study is to evaluate the safety and effectiveness of the study drug, taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED). The study will last about up to 25 months for each participant.
Conditions: Erectile Dysfunction.
Primary outcome: Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious); Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation.
Enrollment: 635 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 635 participants or records.
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