The Management of Erectile Dysfunction With Placebo Only

NCT00882934 | Completed DMC

• 1 other identifier: DAFA06
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Impotence; Erectile Dysfunction

Keywords

Placebo; Placebo Effect; Sexual Dysfunction; Erectile Dysfunction; Clinical Trial

Outcome Measures

Primary Outcomes (2)

• IIEF erectile function domain score

  4 AND 8 Weeks

• Quality of Erection Questionnaire (QEQ)

  4 and 8 weeks

Secondary Outcomes (4)

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

  4 and 8 weeks

• SEAR questionnaire

  4 and 8 weeks

• EDITS questionnaire

  4 and 8 weeks

• GEAQ questionnaire

  4 and 8 weeks

Study Arms (3)

A1

EXPERIMENTAL

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

Other: Induction to efficient treatment

A2

PLACEBO COMPARATOR

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

A3

EXPERIMENTAL

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

Other: Induction to ineffective treatment

Interventions

Induction to efficient treatment OTHER

Informative letters.

A1

Doubt to the efficacy of treatment OTHER

Informative letters.

A2

Induction to ineffective treatment OTHER

Informative letters

A3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rio de Janeiro State University: lead

MeSH Terms

Conditions

Erectile Dysfunction; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Eloisio Alexsandro da Silva, MD, PhD

  Laboratory for Translational Research in Urology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 17, 2009
• Study Start: October 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: January 1, 2008
• Last Updated: April 17, 2009

Record last verified: 2009-04