The Management of Erectile Dysfunction With Placebo Only (DAFA06)

This study has been completed.
Sponsor:
Information provided by:
Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT00882934
First received: April 15, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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 Intervention
Impotence
Erectile Dysfunction
Other: Induction to efficient treatment
Other: Doubt to the efficacy of treatment
Other: Induction to ineffective treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Rio de Janeiro State University:

Primary Outcome Measures:
  • IIEF erectile function domain score [ Time Frame: 4 AND 8 Weeks ] [ Designated as safety issue: No ]
  • Quality of Erection Questionnaire (QEQ) [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IIEF orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction domain scores [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • SEAR questionnaire [ Time Frame: 4 and 8 weeks ]
  • EDITS questionnaire [ Time Frame: 4 and 8 weeks ]
  • GEAQ questionnaire [ Time Frame: 4 and 8 weeks ]

Enrollment: 123
Study Start Date: October 2006
Study Completion Date: January 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882934

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

No publications provided

Responsible Party: Eloisio Alexsandro da Silva, Service of Urology. Laboratory for Translational Research in Urology
ClinicalTrials.gov Identifier: NCT00882934     History of Changes
Other Study ID Numbers: DAFA06
Study First Received: April 15, 2009
Last Updated: April 15, 2009
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 18, 2014