Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT00882934
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00882934
Study Brief:
Protocol Section:
NCT00882934