Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patients With Diabetes.

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Male

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.

Criteria

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;