Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

NCT05558007 | Recruiting Phase 2 DMC

• 1 other identifier: BZ371CLI004
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction; Prostate Cancer; Radical Prostatectomy

Keywords

Erectile Dysfunction; Radical Prostatectomy; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Assisted Erectile Function

  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 Outcomes (12)

• Change in successful vaginal intercourse rate

  From up to 30 days before Baseline, Baseline, 30 days, 60 days

• Change in quality of sexual intercourse

  30 days, 60 days

• Change in penile extension

  Baseline, 30 days, 60 days

• Penile Blood flow increase

  From up to 30 days before Baseline, Baseline, 30 days, 60 days

• Adverse effects report

  Baseline 30 days, 60 days and 75 days

Study Arms (3)

Daily oral Tadalafil 5mg + Topical Placebo

ACTIVE COMPARATOR

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

Drug: Tadalafil 5mg; Drug: Topical Placebo

Daily oral placebo + topical BZ371A

EXPERIMENTAL

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

Drug: BZ371A; Drug: Oral Placebo

Daily oral Tadalafil 5mg + topical BZ371A

ACTIVE COMPARATOR

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

Drug: Tadalafil 5mg; Drug: BZ371A

Interventions

Tadalafil 5mg DRUG

Daily oral administration of tadalafil 5mg

Also known as: Tadalafil

Daily oral Tadalafil 5mg + Topical Placebo; Daily oral Tadalafil 5mg + topical BZ371A

BZ371A DRUG

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

Daily oral Tadalafil 5mg + topical BZ371A; Daily oral placebo + topical BZ371A

Oral Placebo DRUG

Oral administration of a placebo pill

Daily oral placebo + topical BZ371A

Topical Placebo DRUG

Topical application of 1.5 mL of placebo

Daily oral Tadalafil 5mg + Topical Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Erectile function prior to normal RP, defined as IIEF questionnaire with more than 22 points in domain A;
• Stable sexual partner (more than 2 months prior to RP), and intention to maintain the relationship during the study.
• Continuous use of 5mg Tadalafil from the 30th up to the 60th day after RP.

You may not qualify if:

• 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%);
• Prior spinal cord injury with lower limb paralysis;
• 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);
• Patients with current depression, characterized by use or need for use of antidepressants.
• 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;
• Use of topical medications in the genital region that may interfere in the IP evaluation, as well as in its absorption or drug interaction;
• Possession of penile prosthesis;
• 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;
• 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.
• 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;
• 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";
• Diseases that can cause priapism, such as sickle cell anemia, multiple myeloma, or leukemia;

Sponsors & Collaborators

• Biozeus Biopharmaceutical S.A.: lead

Study Sites (1)

Hospital Urológica

Belo Horizonte, Brazil

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Prostatic Neoplasms

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Luiz Otávio Torres, Dr

  Hospital Urológica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla NR Trindade, PhD

CONTACT

+55(21)2523-9089; camilla.nunes@biozeus.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 28, 2022
• Study Start: November 22, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

BR (1)