Actively Recruiting

Phase 2
Age: 40Years - 65Years
MALE
NCT05558007

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

Led by Biozeus Biopharmaceutical S.A. · Updated on 2024-10-22

72

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

Who Can Participate

Age: 40Years - 65Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men between the ages of 40 and 65 years
  • Exclusive heterosexual men, regardless of race or social class
  • Radical Prostatectomy due to prostate cancer without metastasis
  • Radical Prostatectomy performed less than 60 days before the screening visit
  • Normal erectile function before Radical Prostatectomy, defined as IIEF questionnaire score over 22 in domain A
  • Stable sexual partner for more than 2 months before Radical Prostatectomy and intention to maintain the relationship during the study
  • Continuous use of 5 mg tadalafil daily from the 30th to the 60th day after Radical Prostatectomy
Not Eligible

You will not qualify if you...

  • Prostate cancer classified as TNM stage T3 or T4
  • Perineal and/or open Radical Prostatectomy
  • Need for other prostate cancer treatments besides Radical Prostatectomy, including radiation or hormone therapy
  • Uncontrolled diabetes at screening (HbA1C greater than 10%)
  • Prior spinal cord injury with lower limb paralysis
  • Current male hormone use or hypogonadism defined by low testosterone levels
  • Current depression requiring or using antidepressants
  • Genital lesions or active sexually transmitted diseases affecting local analysis
  • Use of topical genital medications that interfere with study evaluations
  • Presence of penile prosthesis
  • History of symptomatic hypotension or heart and kidney diseases increasing hypotension risk
  • Current use of nitrates or specific interfering medications
  • Significant ECG or lab findings posing risk or affecting study analysis
  • Blood pressure outside safe limits (SBP below 90 or above 170 mmHg, DBP below 50 or above 100 mmHg)
  • Diseases causing priapism such as sickle cell anemia, multiple myeloma, or leukemia
  • History of priapism with painful erections lasting up to 6 hours
  • Current severe diarrhea with associated symptoms
  • Known hypersensitivity to tadalafil or BZ371A
  • History of symptomatic lactose intolerance
  • Low adherence to tadalafil use (less than 80% of pills taken between 30th and 60th day post-surgery)
  • Pregnant or lactating partner
  • Partner of childbearing age unwilling to be exposed to treatment
  • Any significant disease, condition, or physical finding increasing risk or interfering with results, including severe illness, other cancers, mental illness, or substance abuse

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Urológica

Belo Horizonte, Brazil

Actively Recruiting

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Research Team

C

Camilla NR Trindade, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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