NCT00882934

The Management of Erectile Dysfunction With Placebo Only

A Single-Blind, Controlled, Randomized, Parallel-Group Study of the Efficacy of Patients' Awareness on the Composition of the Experimental Drug in the Treatment of Erectile Dysfunction.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Rio de Janeiro State University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Placebo-controlled randomized clinical trials (RCT) are the gold standard to provide applicable evidence for clinical practice. A vast number of RCTs for treatment of several disorders has shown a mean placebo effect of 30%. Erectile dysfunction (ED) is a high prevalent disease and its first-line therapy is oral phosphodiesterase type-5 inhibitor (iPDE5) (i.e., sildenafil, vardenafil and tadalafil). Although the placebo effect in iPDE5 RCT occurred at a rate as high as 50%, in the last decade, with the revolutionary discovery of effective pharmacotherapy for ED, oral iPDE5 has become one of the most common prescribed drugs for men. The objective of this study is to evaluate the influence of patients' awareness on the composition of the therapeutic drug in the outcomes of the oral treatment for ED.

Conditions

• Impotence
• Erectile Dysfunction

Interventions

Type	Name	Description
OTHER	Induction to efficient treatment	Informative letters.
OTHER	Doubt to the efficacy of treatment	Informative letters.
OTHER	Induction to ineffective treatment	Informative letters

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-10-01
• Completion: 2008-01-01
• First posted: 2009-04-17
• Last updated: 2009-04-17