The Management of Erectile Dysfunction With Placebo Only (DAFA06)
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|ClinicalTrials.gov Identifier: NCT00882934|
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : April 17, 2009
|Condition or disease||Intervention/treatment||Phase|
|Impotence Erectile Dysfunction||Other: Induction to efficient treatment Other: Doubt to the efficacy of treatment Other: Induction to ineffective treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||January 2008|
Arm 1 received an informative letter explaining that they were allocated to receive a substance for Erectile Dysfunction treatment.
Other: Induction to efficient treatment
Placebo Comparator: A2
Arm 2 (A2) was written informed that they could or could not receive an active drug for ED treatment.
Other: Doubt to the efficacy of treatment
Arm 3 (A3) was properly written informed to be using no effective drug for ED treatment.
Other: Induction to ineffective treatment
- IIEF erectile function domain score [ Time Frame: 4 AND 8 Weeks ]
- Quality of Erection Questionnaire (QEQ) [ Time Frame: 4 and 8 weeks ]
- IIEF orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction domain scores [ Time Frame: 4 and 8 weeks ]
- SEAR questionnaire [ Time Frame: 4 and 8 weeks ]
- EDITS questionnaire [ Time Frame: 4 and 8 weeks ]
- GEAQ questionnaire [ Time Frame: 4 and 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882934
|Study Chair:||Eloisio Alexsandro da Silva, MD, PhD||Laboratory for Translational Research in Urology|