Phase 2 Study of BZ371A Gel and Daily Tadalafil for Men Aged 40 to 65 After Radical Prostatectomy to Improve Erectile Function

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of a topical gel called BZ371A in men who have undergone Radical Prostatectomy RP due to prostate cancer. RP is a common treatment for prostate cancer but can damage nerves that control blood flow to the penis, leading to erectile dysfunction. This study aims to support recovery of erectile function in these patients by assessing BZ371A combined with daily oral tadalafil or compared to placebo. The study includes three groups one receiving daily oral tadalafil with a topical placebo, another receiving daily oral placebo with topical BZ371A, and a third group receiving both daily oral tadalafil and topical BZ371A. The topical gel is applied in a 1.5 mL dose with a concentration of 5 mgmL. Treatments are administered over a period starting shortly after surgery, with patients using the treatments daily and followed for up to 75 days post-baseline. Participants will undergo assessments including erectile function questionnaires, vaginal intercourse success rates, sexual quality evaluations, and measurements of penile extension and blood flow at various points throughout the study. Safety will be monitored through physical exams, blood pressure, heart rate, ECGs, blood and urine tests, and adverse event reports. The primary outcome is the change in assisted erectile function measured from before baseline through 60 days after treatment, with continued monitoring until 75 days after baseline.

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients