Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patient With Type II Diabetes. Multicentric Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 试验地点
- 3
- 主要终点
- Evidence that lodenafil carbonate improves erectile function in patients with diabetes type 2.
研究概览
简要总结
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.
详细描述
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 consent form;
- Investigator will clinically evaluate the subjects regarding eligibility criteria;
- Safety laboratory tests will be perform ;
- Patients will answer the erectile function domain of the International Index of Erectile Function (IIEF);
Study coordinator:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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;
- •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;
研究组 & 干预措施
lodenafil carbonate (Helleva®)
干预措施: lodenafil carbonate (Drug)
结局指标
主要结局
Evidence that lodenafil carbonate improves erectile function in patients with diabetes type 2.
时间窗: 16 mounths
Efficacy is assessing by files of patients including questionnaires like IIEF, SEP and EHS.
次要结局
- Adverse events in type 2 diabetes patients taking lodenafil carbonate and laboratory tests changes after this treatment.(16 months)