Spots Global Cancer Trial Database for Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

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Trial Identification

Brief Title: Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

Official Title: Phase 2 Clinical Trial to Evaluate Safety and Efficacy of BZ371A In A Gel Applied in Patients That Performed Radical Prostatectomy

Study ID: NCT05558007

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Erectile Dysfunction

Prostate Cancer

Radical Prostatectomy

Interventions

Study Description

Brief Summary: To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.

Detailed Description: Prostate cancer remains one of the most prevalent cancer in men. For its treatment, recent technological advances demonstrate that the most effective treatment is the Radical Prostatectomy (RP) procedure. However, although curative for Prostate Cancer, can result in damage to the cavernosal nerves. The cavernosal autonomic nerves travel posterolaterally to the prostate to enter the penis and regulate blood flow and hence erection. Thus, damage caused by RP will affect NO tissue release and blood flow regulation, causing erectile dysfunction. BZ371A has the ability to restore local blood flow regulation by a new and innovative mechanism of action and, therefore, has potential to be a supportive therapy for RP patients (restoring the erectile function). Thus, this study aims to evaluate efficacy, safety and tolerabilty of BZ371A on the recovery of erectile function of patients that were underwent Radical Prostatectomy.