Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

October 18, 2024 updated by: Biozeus Biopharmaceutical S.A.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prostate cancer remains one of the most prevalent cancer in men. For its treatment, recent technological advances demonstrate that the most effective treatment is the Radical Prostatectomy (RP) procedure. However, although curative for Prostate Cancer, can result in damage to the cavernosal nerves.

The cavernosal autonomic nerves travel posterolaterally to the prostate to enter the penis and regulate blood flow and hence erection. Thus, damage caused by RP will affect NO tissue release and blood flow regulation, causing erectile dysfunction.

BZ371A has the ability to restore local blood flow regulation by a new and innovative mechanism of action and, therefore, has potential to be a supportive therapy for RP patients (restoring the erectile function).

Thus, this study aims to evaluate efficacy, safety and tolerabilty of BZ371A on the recovery of erectile function of patients that were underwent Radical Prostatectomy.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men between the ages of 40 and 65 years;
  2. Exclusive heterosexual men, regardless of race or social class.
  3. RP due to prostate cancer without metastasis;
  4. RP performed less than 60 days before the screening visit;
  5. Erectile function prior to normal RP, defined as IIEF questionnaire with more than 22 points in domain A;
  6. Stable sexual partner (more than 2 months prior to RP), and intention to maintain the relationship during the study.
  7. Continuous use of 5mg Tadalafil from the 30th up to the 60th day after RP.

Exclusion Criteria:

  1. Prostate cancer in TNM stage classified as T3 or T4.
  2. Perineal and/or open RP;
  3. Necessity of other therapy for prostate cancer than RP, including radiation therapy or hormone therapy;
  4. Uncontrolled diabetes at screening visit (HbA1C > 10%);
  5. Prior spinal cord injury with lower limb paralysis;
  6. 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);
  7. Patients with current depression, characterized by use or need for use of antidepressants.
  8. 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;
  9. Use of topical medications in the genital region that may interfere in the IP evaluation, as well as in its absorption or drug interaction;
  10. Possession of penile prosthesis;
  11. 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;
  12. 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.
  13. 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;
  14. 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";
  15. Diseases that can cause priapism, such as sickle cell anemia, multiple myeloma, or leukemia;
  16. Histroy of priapism, defined as painful erection from up to 6 hours.
  17. 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;
  18. Known hypersensitivity to tadalafil and/or BZ371A;
  19. History of symptomatic Lactose intolorence such as: the necessity of enzymatic treatment, abdominal distension or diarrhea when ingesting products or supplements with lactose;
  20. Low adhsesion to 5mg Tadalafil use, characterized by the use of <80% of the pills between the 30th and 60th day post PR;.
  21. Pregnant or lacting partner.
  22. Partner in childbearing age which does not accept to get exposed to the treatment
  23. 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Daily oral Tadalafil 5mg + Topical Placebo
Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical placebo
Drug: Tadalafil 5mg
Daily oral administration of tadalafil 5mg
Other Names:
  • Tadalafil
Drug: Topical Placebo
Topical application of 1.5 mL of placebo
Experimental: Daily oral placebo + topical BZ371A
Patient that underwent Radical Prostatectomy will receive daily oral placebo and topical BZ371A
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
Active Comparator: Daily oral Tadalafil 5mg + topical BZ371A
Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical BZ371A
Drug: Tadalafil 5mg
Daily oral administration of tadalafil 5mg
Other Names:
  • Tadalafil
Drug: BZ371A
Topical application of 1.5 mL of BZ371A in a concentration of 5mg/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Assisted Erectile Function
Time Frame: From up to 30 days before Baseline, Baseline, 30 days, 60 days
Measurement of the ability to to have an erection that allows sexual intercourse, under use of medication. This will be assessed by using the IIEF questionnaire, domain A (erectile function section) (IIEF-EF).
From up to 30 days before Baseline, Baseline, 30 days, 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of sexual intercourse
Time Frame: 30 days, 60 days
Quality of sexual intercourse, through the EDITS questionnaire (Erectile Dysfunction Inventory of Treatment Satisfaction);
30 days, 60 days
Change in penile extension
Time Frame: Baseline, 30 days, 60 days
Penile extension, measured with a ruler.
Baseline, 30 days, 60 days
Change in successful vaginal intercourse rate
Time Frame: From up to 30 days before Baseline, Baseline, 30 days, 60 days
Rate of successful vaginal intercourse will be assessed through question 3 of the SEP (Sexual Encouter Profile) questionnaire.
From up to 30 days before Baseline, Baseline, 30 days, 60 days
Penile Blood flow increase
Time Frame: From up to 30 days before Baseline, Baseline, 30 days, 60 days
Increased blood flow, assessed by peak systolic velocity (PSV), end-diastolic velocity (EDV) and resistivity index (RI) assessed by Doppler examination;
From up to 30 days before Baseline, Baseline, 30 days, 60 days
Adverse effects report
Time Frame: Baseline 30 days, 60 days and 75 days
Adverse effects evaluation of compound use and application
Baseline 30 days, 60 days and 75 days
Physical examination of the applied region
Time Frame: From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days
Number of participants with abnormal physical exam findings in the applied region
From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days
Change in SBP
Time Frame: From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days
Change in Systolic Blood Pressure
From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days
Change in DBP
Time Frame: From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days
Change in Diastolic Blood Pressure
From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days
Change in Heart Rate (HR)
Time Frame: From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days
Change in Heart Rate
From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days
Basal chest electrocardiogram (ECG).
Time Frame: From up to 30 days before Baseline, 30 days and 60 days
Number of participants with abnormal ECG test results
From up to 30 days before Baseline, 30 days and 60 days
Blood evaluation
Time Frame: From up to 30 days before Baseline, and 60 days
Number of participants with abnormal laboratory test results
From up to 30 days before Baseline, and 60 days
Urine evaluation
Time Frame: From up to 30 days before Baseline, and 60 days
Number of participants with abnormal laboratory test results
From up to 30 days before Baseline, and 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biozeus Biopharmaceutical S.A.

Investigators

  • Principal Investigator: Luiz Otávio Torres, Dr, Hospital Urológica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

September 23, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BZ371CLI004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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