| Trial ID: | L6484 |
| Source ID: | NCT01180283
|
| Associated Drug: |
Lodenafil Carbonate
|
| Title: |
Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patients With Diabetes.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Erectile Dysfunction
|
| Interventions: |
DRUG: lodenafil carbonate
|
| Outcome Measures: |
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 | 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
|
| Sponsor/Collaborators: |
Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-01
|
| Completion Date: |
2010-04
|
| Results First Posted: |
|
| Last Update Posted: |
2010-08-12
|
| Locations: |
Hospital do Servidor Público Estadual de São Paulo, São Paulo, SP, 04039-004, Brazil|Faculdade de Medicina do ABC, Santo André, São Paulo, 09060-650, Brazil|Hospital Ipiranga, São Paulo, 04262-000, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT01180283
|
