The Management of Erectile Dysfunction With Placebo Only (DAFA06)

This study has been completed.
Sponsor:
Information provided by:
Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT00882934
First received: April 15, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

April 15, 2009
April 15, 2009
October 2006
October 2007   (final data collection date for primary outcome measure)
  • IIEF erectile function domain score [ Time Frame: 4 AND 8 Weeks ] [ Designated as safety issue: No ]
  • Quality of Erection Questionnaire (QEQ) [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • IIEF orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction domain scores [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • SEAR questionnaire [ Time Frame: 4 and 8 weeks ]
  • EDITS questionnaire [ Time Frame: 4 and 8 weeks ]
  • GEAQ questionnaire [ Time Frame: 4 and 8 weeks ]
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Impotence
  • Erectile Dysfunction
  • Other: Induction to efficient treatment
    Informative letters.
  • Other: Doubt to the efficacy of treatment
    Informative letters.
  • Other: Induction to ineffective treatment
    Informative letters
  • Experimental: A1
    Arm 1 received an informative letter explaining that they were allocated to receive a substance for Erectile Dysfunction treatment.
    Intervention: 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.
    Intervention: Other: Doubt to the efficacy of treatment
  • Experimental: A3
    Arm 3 (A3) was properly written informed to be using no effective drug for ED treatment.
    Intervention: Other: Induction to ineffective treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
January 2008
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older
  • Complaint of ED for at least 6 months prior the start of the study, according to medical history and to the questionnaires IIEF, SEAR and QEQ.
  • A stable heterosexual relationship.
  • To be in good health prior the participation in the study, with no important clinical abnormalities, determined by: clinical history, physical examination, blood chemistry and hematology, urinalysis (If the standard values of the laboratory for these tests are not evidenced, subjects can be included if the researcher consider the changes as not clinically significant).

Exclusion Criteria:

  • History of significant cardiovascular, pulmonary, gastrointestinal, hematological, neurological (including epilepsy), locomotor, immunologic, ophthalmic, metabolic, endocrine, thromboembolic, rheumatologic, cancer, kidney or liver disease.
  • Diagnosis of psychiatric conditions, e.g. depression, anxiety, dysthymia, mania, panic, agoraphobia, social phobia, suicidal ideation, obsessive-compulsive disorder, post-traumatic stress, psychotic disorders, schizophrenia, alcoholism, dependence on psycho-active substances.
  • History of HIV, hepatitis B or hepatitis C.
  • Hyperprolactinemia or untreated hypothyroidism.
  • Any condition, which, in the opinion of the investigator, may interfere with the participation of the subject in the study (e.g. difficulty to meet the requirements of the study, attend the consultations, answer the questionnaires).
  • Report of significant clinical problems by the subject's partner, such as decreased sexual interest, pain during relations or other forms of sexual dysfunction that interfere in the relationship with the sexual partner.
  • Patient or partner willing to undergo a surgical procedure during the study period, which may interfere in the results.
  • Peyronie's disease, which may lead to impossibility to penetrate or cause pain during the sexual intercourse.
  • Use of nitrates.
  • Illiterate patient.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00882934
DAFA06
Yes
Eloisio Alexsandro da Silva, Service of Urology. Laboratory for Translational Research in Urology
Rio de Janeiro State University
Not Provided
Study Chair: Eloisio Alexsandro da Silva, MD, PhD Laboratory for Translational Research in Urology
Rio de Janeiro State University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP