Erectile Dysfunction Clinical Trial
Official title:
Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patient With Type II Diabetes. Multicentric Study.
Sixty diabetes men with erectile dysfunction from mild to severe who agree to participate is
going to have medical care approximately for 16 weeks.
During the first 4 weeks, patients will not receive any inhibitor of phosphodiesterase 5. In
the following eight weeks, patients will receive oral lodenafil carbonate. They will
complete the International Index of Erectile Dysfunction (IIEF) questionnaire in the site
and answer the Sexual Encounter Profile (SEP) questions 2 and 3 and the Erection Hadness
Score (EHS) after each intercourse or attempt without or using oral lodenafil cardonate
80mg.
Questionnaire of adverse event is included in patient diary.
Status | Completed |
Enrollment | 0 |
Est. completion date | April 2010 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Diabetes type II; - Age from 18 to 65 years; - Erectile dysfunction within the previous 6 months; - Mild, moderate or severe erectile dysfunction by IIEF questionnaire; - Stable sexual partner in the past 2 months; - Preserved libido; - Studied at least up to fourth grade; Exclusion Criteria: - Current beta blocker, thiazide, alpha methyldopa, antidepressants, or antiandrogen therapy intake; - Penile prosthesis; - Previous intolerance to sildenafil, vardenafil, tadalafil or lodenafil carbonate; - Previous negative response to iPDE-5 correct use.; - Penile anatomical deformities; - Previous penile surgeries for erectile dysfunction, premature ejaculation or penile enlargement; - Myocardial infarction or cerebral vascular accident within the previous 6 months; - Severe or uncontrolled cardiac diseases; - Spinal cord injury, multiple sclerosis, retinitis pigmentosa; - Radical pelvic surgery and pelvic radiotherapy, including radical prostatectomy; - Myocardial or Coronary Artery disease with cardiologist contraindication for using iPDE5; - Cancer; - Anaphylactic reactions or Steven-Johnson disease; - Participation in another clinical trial within the last 2 months; - Sexually transmitted diseases; - Glycated hemoglobin > 12%; - Testosterone < 200ng/dL; - Prolactin > 20ng/dL; - Hemoglobin < 10g/dL; - Leucocytes > 14.000 cel/mm3; - TGO > 100 U/L; - TGP > 100 U/L; - Creatina > 2 mg/dL; - Investigator´s opinion; |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Faculdade de Medicina do ABC | Santo André | São Paulo |
Brazil | Hospital do Servidor Público Estadual de São Paulo | São Paulo | SP |
Brazil | Hospital Ipiranga | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Cristália Produtos Químicos Farmacêuticos Ltda. |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evidence that lodenafil carbonate improves erectile function in patients with diabetes type 2. | Efficacy is assessing by files of patients including questionnaires like IIEF, SEP and EHS. | 16 mounths | No |
Secondary | Adverse events in type 2 diabetes patients taking lodenafil carbonate and laboratory tests changes after this treatment. | Investigator will interview patients to fill adverse events reports. Laboratory tests results before and after lodenafil carbonate treatment will be analyzed and compared, in order to detect significant changes. |
16 months | Yes |
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