Biozeus Biopharmaceutical S.A.
To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.
Erectile Dysfunction Following Radical Prostatectomy
Erectile Dysfunction
Prostate Cancer
Radical Prostatectomy
Tadalafil 5mg
BZ371A
Oral Placebo
Topical Placebo
Phase 2
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.
Study Type : | Interventional |
Estimated Enrollment : | 72 participants |
Masking: | Quadruple |
Primary Purpose: | Treatment |
Official Title: | Phase 2 Clinical Trial to Evaluate Safety and Efficacy of BZ371A In A Gel Applied in Patients That Performed Radical Prostatectomy |
Actual Study Start Date : | November 22, 2023 |
Estimated Primary Completion Date : | August 2024 |
Estimated Study Completion Date : | September 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Daily oral Tadalafil 5mg + Topical Placebo Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical placebo |
Drug: Tadalafil 5mg Drug: Topical Placebo |
Experimental: Daily oral placebo + topical BZ371A Patient that underwent Radical Prostatectomy will receive daily oral placebo and topical BZ371A |
Drug: BZ371A Drug: Oral Placebo |
Active Comparator: Daily oral Tadalafil 5mg + topical BZ371A Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical BZ371A |
Drug: Tadalafil 5mg Drug: BZ371A |
Ages Eligible for Study: | 40 Years to 65 Years |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Hospital Urológica
Belo Horizonte, Brazil,