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The Management of Erectile Dysfunction With Placebo Only

NCT00882934 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2009-04-17

No results posted yet for this study

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

Interventions

OTHER

Induction to efficient treatment

Informative letters.

OTHER

Doubt to the efficacy of treatment

Informative letters.

OTHER

Induction to ineffective treatment

Informative letters

Sponsors & Collaborators

  • Rio de Janeiro State University

    lead OTHER

Principal Investigators

  • Eloisio Alexsandro da Silva, MD, PhD · Laboratory for Translational Research in Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-10-31
Completion
2008-01-31

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Entities

Diseases

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 NCT00882934 on ClinicalTrials.gov