Assessment of the effects of two different formulations of the same drug on the ability to obtain and maintain an erection which is adequate for satisfying sexual activity

Phase 1

Active, not recruiting

• Conditions: Erectile Dysfunction; MedDRA version: 20.0Level: PTClassification code 10061461Term: Erectile dysfunctionSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2018-001418-14-IT
• Lead Sponsor: MBERTO I - POLICLINICO DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 118

Inclusion Criteria

-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

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified