Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

  • Recruiting
  • Treatment
  • Interventional
  • Randomized
  • Drug
  • PHASE2
  • Biozeus Biopharmaceutical S.A.
  • 40 - 65 Years


Study Purpose

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

Intervention

Drug : Tadalafil 5mg

Drug : BZ371A

Drug : Oral Placebo

Drug : Topical Placebo


Eligibility Requirements

info icon Men between the ages of 40 and 65 years;

info icon Exclusive heterosexual men, regardless of race or social class.

info icon RP due to prostate cancer without metastasis;

info icon RP performed less than 60 days before the screening visit;

info icon Erectile function prior to normal RP, defined as IIEF questionnaire with more than 22 points in domain A;

info icon Stable sexual partner (more than 2 months prior to RP), and intention to maintain the relationship during the study.

info icon Continuous use of 5mg Tadalafil from the 30th up to the 60th day after RP.

info icon Prostate cancer in TNM stage classified as T3 or T4.

info icon Perineal and/or open RP;

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

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

info icon Prior spinal cord injury with lower limb paralysis;

info icon Current male hormone use, or hypogonadism, defined by total testosterone below 8 nmol/L (2300 pg/mL) or total testosterone between 8 and 11 nmol/L (2300 and 3170 pg/mL) and free testosterone \< 220 pmol/L (\< 64 ng/dL);

info icon Patients with current depression, characterized by use or need for use of antidepressants.

info icon Presence of genital lesions (such as severe penile fibrosis or Peyronie's disease) or active sexually transmitted disease (STD) (such as herpes, gonorrhea, candidiasis, HPV, and others) that impair analysis of local adverse effects on the genitalia;

info icon Use of topical medications in the genital region that may interfere in the IP evaluation, as well as in its absorption or drug interaction;

info icon Possession of penile prosthesis;

info icon History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patient with heart diseases (including history of angina and/or heart failure) and nephropathies;

info icon Current use of nitrates, such as propatilnitrate (Sustrate®), isosorbide (Monocordil®, Cincordil®, Isordil®), nitroglycerin (Nitradisc®, Nitroderm TTS®, Nitronal®, Tridil®) and isosorbitol dinitrate (Isocord®);ketoconazole; ritonavir; and rifampicin.

info icon Findings on ECG and/or laboratory tests that, in the Investigator's criteria, are considered significant and offer risk to the research volunteer's participation or may hinder the study analyses;

info icon BP outside the limits considered safe: SBP below 90 mmHg or above 170 mmHg; or DBP below 50 mmHg or above 100 mmHg, except situations such as "white coat syndrome";

info icon Diseases that can cause priapism, such as sickle cell anemia, multiple myeloma, or leukemia;

info icon Histroy of priapism, defined as painful erection from up to 6 hours.

info icon Current relevant diarrhea, defined as duration over four weeks, association with abdominal pain or dysabsortive syndrome, or presence of mucus, pus, or blood in the stool;

info icon Known hypersensitivity to tadalafil and/or BZ371A;

info icon History of symptomatic Lactose intolorence such as: the necessity of enzymatic treatment, abdominal distension or diarrhea when ingesting products or supplements with lactose;

info icon Low adhsesion to 5mg Tadalafil use, characterized by the use of \<80% of the pills between the 30th and 60th day post PR;.

info icon Pregnant or lacting partner.

info icon Partner in childbearing age which does not accept to get exposed to the treatment

info icon Any disease, condition or physical finding that the Investigator considers significant and that increases the risk of the research subject's participation or may interfere with the results, including severe debilitating illness, presence of cancer other than prostate cancer, severe mental illness persistent medication abuse;

Recruiting status

Recruiting

Estimated enrollment

72

 
Study start date

Nov 22, 2023

Study end date

Jan 31, 2025

Last updated

Mar 22, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE2

Allocation

Randomized

 

Sponsor:

Biozeus Biopharmaceutical S.A.

Collaborator:

N/A

Investigator:

Luiz Otávio Torres, Dr

NCT05558007

Clinic Location Investigator Distance RECRUITING STATUS Contact