RecruitingPhase 2NCT05558007

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


Sponsor

Biozeus Biopharmaceutical S.A.

Enrollment

72 participants

Start Date

Nov 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: MALEMin Age: 40 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a topical cream called BZ371A applied to the penis of men who have had their prostate removed (prostatectomy) for cancer, to see if it helps preserve or restore the ability to get erections after surgery. **You may be eligible if:** - You are a man between 40 and 65 years old - You identify as heterosexual - You had your prostate removed for cancer without spreading to other organs, within the last 60 days - You had normal erectile function before surgery (IIEF questionnaire score above 22) - You have a stable sexual partner and are continuing that relationship - You are already using a daily low-dose tadalafil (a common erectile dysfunction drug) as part of your recovery **You may NOT be eligible if:** - Your prostate cancer was advanced (T3 or T4 stage) - You had open or perineal (non-robotic/non-laparoscopic) prostatectomy - You need additional cancer treatment (radiation or hormone therapy) - You have uncontrolled diabetes - You have low testosterone or are using male hormone therapy - You currently have depression or are on antidepressants Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTadalafil 5mg

Daily oral administration of tadalafil 5mg

DRUGBZ371A

Topical application of 1.5 mL of BZ371A in a concentration of 5mg/mL

DRUGOral Placebo

Oral administration of a placebo pill

DRUGTopical Placebo

Topical application of 1.5 mL of placebo


Locations(1)

Hospital Urológica

Belo Horizonte, Brazil

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NCT05558007


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