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Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

NCT05558007 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-10-22

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Biozeus Biopharmaceutical S.A.

    lead INDUSTRY

Principal Investigators

  • Luiz Otávio Torres, Dr · Hospital Urológica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2024-12-31
Completion
2025-01-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05558007 on ClinicalTrials.gov