Health Trials

About this trial

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

Eligibility criteria

Qualifiers

Men between the ages of 40 and 65 years;

Exclusive heterosexual men, regardless of race or social class.

RP due to prostate cancer without metastasis;

RP performed less than 60 days before the screening visit;

Disqualifiers

Prostate cancer in TNM stage classified as T3 or T4.

Perineal and/or open RP;

Necessity of other therapy for prostate cancer than RP, including radiation therapy or hormone therapy;

Uncontrolled diabetes at screening visit (HbA1C > 10%);

Trial design

Treatments tested in this trial

  • Tadalafil 5mg
  • BZ371A
  • Oral Placebo
  • Topical Placebo

Treatment groups

72 Participants
are divided into 3 treatment groups

Locations

1
Hospital Urológica Belo Horizonte Brazil

Sponsors and collaborators

Biozeus Biopharmaceutical S.A.

Lead sponsor

Source ClinicalTrials.gov