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The Management of Erectile Dysfunction With Placebo Only (DAFA06)

Primary Purpose

Impotence, Erectile Dysfunction

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Induction to efficient treatment

Doubt to the efficacy of treatment

Induction to ineffective treatment

About this trial

This is an interventional treatment trial for Impotence focused on measuring Placebo, Placebo Effect, Sexual Dysfunction, Erectile Dysfunction, Clinical Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Arm Description

Arm 1 received an informative letter explaining that they were allocated to receive a substance for Erectile Dysfunction treatment.

Arm 2 (A2) was written informed that they could or could not receive an active drug for ED treatment.

Arm 3 (A3) was properly written informed to be using no effective drug for ED treatment.

Outcomes

Primary Outcome Measures

IIEF erectile function domain score

Quality of Erection Questionnaire (QEQ)

Secondary Outcome Measures

IIEF orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction domain scores

SEAR questionnaire

EDITS questionnaire

GEAQ questionnaire

Full Information

NCT ID

NCT00882934

First Posted

April 15, 2009

Last Updated

April 15, 2009

Sponsor

Rio de Janeiro State University

1. Study Identification

Unique Protocol Identification Number

NCT00882934

Brief Title

The Management of Erectile Dysfunction With Placebo Only

Acronym

DAFA06

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 Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rio de Janeiro State University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impotence, Erectile Dysfunction

Keywords

Placebo, Placebo Effect, Sexual Dysfunction, Erectile Dysfunction, Clinical Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm 1 received an informative letter explaining that they were allocated to receive a substance for Erectile Dysfunction treatment.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Arm 2 (A2) was written informed that they could or could not receive an active drug for ED treatment.

Arm Title

Arm Type

Experimental

Arm Description

Arm 3 (A3) was properly written informed to be using no effective drug for ED treatment.

Intervention Type

Other

Intervention Name(s)

Induction to efficient treatment

Intervention Description

Informative letters.

Intervention Type

Other

Intervention Name(s)

Doubt to the efficacy of treatment

Intervention Description

Informative letters.

Intervention Type

Other

Intervention Name(s)

Induction to ineffective treatment

Intervention Description

Informative letters

Primary Outcome Measure Information:

Title

IIEF erectile function domain score

Time Frame

4 AND 8 Weeks

Title

Quality of Erection Questionnaire (QEQ)

Time Frame

4 and 8 weeks

Secondary Outcome Measure Information:

Title

IIEF orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction domain scores

Time Frame

4 and 8 weeks

Title

SEAR questionnaire

Time Frame

4 and 8 weeks

Title

EDITS questionnaire

Time Frame

4 and 8 weeks

Title

GEAQ questionnaire

Time Frame

4 and 8 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eloisio Alexsandro da Silva, MD, PhD

Organizational Affiliation

Laboratory for Translational Research in Urology

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

The Management of Erectile Dysfunction With Placebo Only

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