Status:
COMPLETED
Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patients With Diabetes.
Lead Sponsor:
Cristália Produtos Químicos Farmacêuticos Ltda.
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18-65 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
This is a prospective, fixed dose, open label study. The run in period from inclusion to conclusion will be between fourteen and sixteen weeks. Visit zero (Vo): * Patients will sign the informed co...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01180283
Start Date
January 1 2009
End Date
April 1 2010
Last Update
August 12 2010
Active Locations (3)
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1
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil, 09060-650
2
Hospital do Servidor Público Estadual de São Paulo
São Paulo, São Paulo, Brazil, 04039-004
3
Hospital Ipiranga
São Paulo, São Paulo, Brazil, 04262-000