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The Management of Erectile Dysfunction With Placebo Only (DAFA06)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00882934
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : April 17, 2009
Information provided by:
Rio de Janeiro State University

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A1
Arm 1 received an informative letter explaining that they were allocated to receive a substance for Erectile Dysfunction treatment.
Other: Induction to efficient treatment
Informative letters.

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
Informative letters.

Experimental: A3
Arm 3 (A3) was properly written informed to be using no effective drug for ED treatment.
Other: Induction to ineffective treatment
Informative letters

Primary Outcome Measures :
  1. IIEF erectile function domain score [ Time Frame: 4 AND 8 Weeks ]
  2. Quality of Erection Questionnaire (QEQ) [ Time Frame: 4 and 8 weeks ]

Secondary Outcome Measures :
  1. IIEF orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction domain scores [ Time Frame: 4 and 8 weeks ]
  2. SEAR questionnaire [ Time Frame: 4 and 8 weeks ]
  3. EDITS questionnaire [ Time Frame: 4 and 8 weeks ]
  4. GEAQ questionnaire [ Time Frame: 4 and 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00882934

Sponsors and Collaborators
Rio de Janeiro State University
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Study Chair: Eloisio Alexsandro da Silva, MD, PhD Laboratory for Translational Research in Urology

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Responsible Party: Eloisio Alexsandro da Silva, Service of Urology. Laboratory for Translational Research in Urology Identifier: NCT00882934     History of Changes
Other Study ID Numbers: DAFA06
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: April 17, 2009
Last Verified: April 2009

Keywords provided by Rio de Janeiro State University:
Placebo Effect
Sexual Dysfunction
Erectile Dysfunction
Clinical Trial

Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders