The Management of Erectile Dysfunction With Placebo Only

NCT ID: NCT00882934

Last Updated: 2009-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A1

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

Group Type: EXPERIMENTAL

Induction to efficient treatment

Intervention Type: OTHER

Informative letters.

A2

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

Group Type: PLACEBO_COMPARATOR

Doubt to the efficacy of treatment

Intervention Type: OTHER

Informative letters.

A3

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

Group Type: EXPERIMENTAL

Induction to ineffective treatment

Intervention Type: OTHER

Informative letters

Interventions

Induction to efficient treatment

Informative letters.

Intervention Type: OTHER

Doubt to the efficacy of treatment

Informative letters.

Intervention Type: OTHER

Induction to ineffective treatment

Informative letters

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: lead

Responsible Party

Service of Urology. Laboratory for Translational Research in Urology

Principal Investigators

Eloisio Alexsandro da Silva, MD, PhD

Role: STUDY_CHAIR

Laboratory for Translational Research in Urology

Other Identifiers

DAFA06

Identifier Type: -

Identifier Source: org_study_id