The Management of Erectile Dysfunction With Placebo Only

Erectile Dysfunction Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882934
• Other study ID #: DAFA06
• Status: Completed
• Phase: N/A
• First received: April 15, 2009
• Last updated: April 15, 2009
• Start date: October 2006
• Est. completion date: January 2008

Study information

• Verified date: April 2009
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Impotence

Intervention

Other:
• Induction to efficient treatment
Informative letters.
• Doubt to the efficacy of treatment
Informative letters.
• Induction to ineffective treatment
Informative letters

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IIEF erectile function domain score		4 AND 8 Weeks	No
Primary	Quality of Erection Questionnaire (QEQ)		4 and 8 weeks	No
Secondary	IIEF orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction domain scores		4 and 8 weeks	No
Secondary	SEAR questionnaire		4 and 8 weeks
Secondary	EDITS questionnaire		4 and 8 weeks
Secondary	GEAQ questionnaire		4 and 8 weeks