Status:
COMPLETED
The Management of Erectile Dysfunction With Placebo Only
Lead Sponsor:
Rio de Janeiro State University
Conditions:
Impotence
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
NA
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 mea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00882934
Start Date
October 1 2006
End Date
January 1 2008
Last Update
April 17 2009
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.