Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT00882934
Status:
COMPLETED
Last Update Posted:
2009-04-17
First Post:
2009-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Management of Erectile Dysfunction With Placebo Only
Sponsor:
Rio de Janeiro State University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAFA06
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: