Trials / Recruiting
RecruitingNCT05558007
Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients
Phase 2 Clinical Trial to Evaluate Safety and Efficacy of BZ371A in a Gel Applied in Patients That Performed Radical Prostatectomy
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- Sponsor
- Biozeus Biopharmaceutical S.A. · Industry
- Sex
- Male
- Age
- 40 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Erectile Dysfunction Following Radical Prostatectomy
- Erectile Dysfunction
- Prostate Cancer
- Radical Prostatectomy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tadalafil 5mg | Daily oral administration of tadalafil 5mg |
| DRUG | BZ371A | Topical application of 1.5 mL of BZ371A in a concentration of 5mg/mL |
| DRUG | Oral Placebo | Oral administration of a placebo pill |
| DRUG | Topical Placebo | Topical application of 1.5 mL of placebo |
Timeline
- Start date
- 2023-11-22
- Primary completion
- 2024-12-31
- Completion
- 2025-01-31
- First posted
- 2022-09-28
- Last updated
- 2024-10-22
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT05558007. Inclusion in this directory is not an endorsement.