Assessment of clinical efficacy of Sildenafil 75 mg orodispersable film vs Sildenafil 100 mg tablet in patients with erectile dysfunction - FAST

MBERTO I - POLICLINICO DI ROMA0 个研究点目标入组 118 人开始时间: 2021年5月20日最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•-Male patients aged 18-72, with a diagnosis of Erectile Dysfunction based on DSM-V criteria
•-Diagnosis of erectile dysfunction in the last 12 months
•-Previous use of PDE-5 inhibitors (discontinued for at least 2 weeks)
•- Written consent to participate to the study for its whole duration
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 118
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 118

•-Psychiatric illnesses
•-Abuse of alcohol and/or psychoactive drugs
•-Neuropathies, including peripheral neuropathies
•-Chronic use of psychiatric drugs
•-Male hypogonadism with total testosterone <12 nmol/l.
•-Treatment with nitrates or androgens.
•-Anatomical penile abnormalities which might cause erectile dysfunction.
•-Severe or moderate kidney or liver disease, recent stroke or myocardial infarction, heart failure
•-Previous use of PDE-5 inhibitors or topically administered proerectile drugs in the last 2 weeks
•-Hypersensitivity to the active substance or any of the excipients
•-Diagnosis of hypotension (blood pressure <90/50 mmHg)
•-Participation to a different clinical trial in the previous 30 days or 5 times the active substance’s half-life
•-Any biochemical alteration which, following the Investigator’s clinical judgement, would make the patient unsuitable for the present study
•-Known hereditary retinal degenerative disorders, such as retinitis pigmentosa

发起方

MBERTO I - POLICLINICO DI ROMA