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RECRUITING
NCT05558007
PHASE2

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

Sponsor: Biozeus Biopharmaceutical S.A.

View on ClinicalTrials.gov

Summary

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

Official title: Phase 2 Clinical Trial to Evaluate Safety and Efficacy of BZ371A in a Gel Applied in Patients That Performed Radical Prostatectomy

Key Details

Gender

MALE

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2023-11-22

Completion Date

2025-01-31

Last Updated

2024-10-22

Healthy Volunteers

No

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

Locations (1)

Hospital Urológica

Belo Horizonte, Brazil