ImpotenceDAFA06NCT00882934
The Management of Erectile Dysfunction With Placebo Only
A study testing Induction to efficient treatment, Doubt to the efficacy of treatment and Induction to ineffective treatment in people with Impotence and Erectile Dysfunction, run by Rio de Janeiro State University.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Impotence, Erectile Dysfunction
- What is being tested?
- Induction to efficient treatment, Doubt to the efficacy of treatment and Induction to ineffective treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
About this study
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.
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
- Being tested
- Induction to efficient treatment, Doubt to the efficacy of treatment, Induction to ineffective treatment
- Keywords
- Placebo, Placebo Effect, Sexual Dysfunction, Erectile Dysfunction, Clinical Trial
- Medical subject headings
- Erectile Dysfunction, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction to efficient treatmentOther
Informative letters.
Doubt to the efficacy of treatmentOther
Informative letters.
Induction to ineffective treatmentOther
Informative letters
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Arm 1 received an informative letter explaining that they were allocated to receive a substance for Erectile Dysfunction treatment. Receives: 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. Receives: 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. Receives: Other: Induction to ineffective treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF erectile function domain score
Measured: 4 AND 8 Weeks
Quality of Erection Questionnaire (QEQ)
Measured: 4 and 8 weeks
Secondary outcomes (4)
IIEF orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction domain scores
Measured: 4 and 8 weeks
SEAR questionnaire
Measured: 4 and 8 weeks
EDITS questionnaire
Measured: 4 and 8 weeks
GEAQ questionnaire
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startOct 2006
- Primary completionOct 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpotenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Investigators
- Eloisio Alexsandro da Silva, MD, PhD, Study chair, Laboratory for Translational Research in Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882934
- Sponsor's protocol ID
- DAFA06
- Acronym
- DAFA06
- Status last verified
- Apr 2009
- First submitted
- 15 Apr 2009
- Last updated
- 17 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00882934
- Acronym / sponsor ID
- DAFA06 / DAFA06
- Conditions
- Impotence, Erectile Dysfunction
- Keywords
- Placebo, Placebo Effect, Sexual Dysfunction, Erectile Dysfunction, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Other: Induction to efficient treatmentArm 1 received an informative letter explaining that they were allocated to receive a substance for Erectile Dysfunction treatment. |
| A2 | Placebo comparator | Other: Doubt to the efficacy of treatmentArm 2 (A2) was written informed that they could or could not receive an active drug for ED treatment. |
| A3 | Experimental | Other: Induction to ineffective treatmentArm 3 (A3) was properly written informed to be using no effective drug for ED treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction to efficient treatmentInformative letters. | Other | A1 |
| Doubt to the efficacy of treatmentInformative letters. | Other | A2 |
| Induction to ineffective treatmentInformative letters | Other | A3 |
Primary outcome
IIEF erectile function domain score
Time frame: 4 AND 8 Weeks
Quality of Erection Questionnaire (QEQ)
Time frame: 4 and 8 weeks
4 secondary outcomes
IIEF orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction domain scores
Time frame: 4 and 8 weeks
SEAR questionnaire
Time frame: 4 and 8 weeks
EDITS questionnaire
Time frame: 4 and 8 weeks
GEAQ questionnaire
Time frame: 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eloisio Alexsandro da Silva, MD, PhD study chair
Laboratory for Translational Research in Urology
Questions about this trial
What is this clinical trial studying?
A study testing Induction to efficient treatment, Doubt to the efficacy of treatment and Induction to ineffective treatment in people with Impotence and Erectile Dysfunction, run by Rio de Janeiro State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IIEF erectile function domain score (time frame: 4 AND 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2009.