Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patients With Diabetes.
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patient With Type II Diabetes. Multicentric Study.|
- Evidence that lodenafil carbonate improves erectile function in patients with diabetes type 2. [ Time Frame: 16 mounths ] [ Designated as safety issue: No ]Efficacy is assessing by files of patients including questionnaires like IIEF, SEP and EHS.
- Adverse events in type 2 diabetes patients taking lodenafil carbonate and laboratory tests changes after this treatment. [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||April 2010|
|Experimental: lodenafil carbonate (Helleva®)||
Drug: lodenafil carbonate
Dosage: lodenafil carbonate 80mg once a day. It should be taken between 6 and 2 hours before the sexual intercounter.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01180283
|Hospital do Servidor Público Estadual de São Paulo|
|São Paulo, SP, Brazil, 04039-004|
|Faculdade de Medicina do ABC|
|Santo André, São Paulo, Brazil, 09060-650|
|São Paulo, Brazil, 04262-000|