Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Erectile Dysfunction

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Healthy patients receiving topical application of BZ371A

Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.

BZ371A

Regina M Doi

The purpose of this study is to evaluate pharmacokinetics, safety and tolerability profile of BZ371A topically administered in healthy patients.

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 has the purpose to evaluate safety, tolerability and pharmacokinetics of a BZ371A single dose, topically administrated at the genital area.

Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered

Phase 1 Clinical Trial Study to Evaluate Pharmacokinetics and Safety Profile of BZ371A in a Gel Formulation, Applied on Healthy Men and Women Genitals

Area under the curve (AUC) of plasma/serum/blood drug concentration-time curve

Adverse effect evaluation of compound use and application

Number of participants with abnormal physical exam findings

Number of participants with abnormal ECG readings

Number of participants with abnormal laboratory test results

Number of participants with abnormal urinalysis

Azidus Brasil Scientific Research and Development Ltda

Biozeus Biopharmaceutical S.A.

Vasodilator Agents

Urological Agents

All Drugs and Chemicals

Tadalafil

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical placebo

Patient that underwent Radical Prostatectomy will receive daily oral placebo and topical BZ371A

Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical BZ371A

Daily oral administration of tadalafil 5mg

Tadalafil 5mg

Topical application of 1.5 mL of BZ371A in a concentration of 5mg/mL

Oral Placebo

Topical Placebo

Camilla NR Trindade, PhD

Luiz Otávio Torres, Dr.

Luiz Otávio Torres, Dr

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

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.

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

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

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).

Rate of successful vaginal intercourse will be assessed through question 3 of the SEP (Sexual Encouter Profile) questionnaire.

Quality of sexual intercourse, through the EDITS questionnaire (Erectile Dysfunction Inventory of Treatment Satisfaction);

Increased blood flow, assessed by peak systolic velocity (PSV), end-diastolic velocity (EDV) and resistivity index (RI) assessed by Doppler examination;

Adverse effects evaluation of compound use and application

Number of participants with abnormal physical exam findings in the applied region

Number of participants with abnormal ECG test results

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered	NCT05332340	Erectile Dysfun... Erectile Dysfun... Prostate Cancer Radical Prostat...	BZ371A	18 Years -	Biozeus Biopharmaceutical S.A.
Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered	NCT05332340	Erectile Dysfun... Erectile Dysfun... Prostate Cancer Radical Prostat...	BZ371A	18 Years -	Biozeus Biopharmaceutical S.A.
Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients	NCT05558007	Erectile Dysfun... Erectile Dysfun... Prostate Cancer Radical Prostat...	Tadalafil 5mg BZ371A Oral Placebo Topical Placebo	40 Years - 65 Years	Biozeus Biopharmaceutical S.A.

Spots Global Cancer Trial Database for bz371a

Every month we try and update this database with for bz371a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bz371a

Every month we try and update this database with for bz371a cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bz371a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.