Erectile Dysfunction Following Radical ProstatectomyPhase 2NCT05558007
Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients
A Phase 2 study testing Tadalafil 5mg and BZ371A in people with Erectile Dysfunction Following Radical Prostatectomy and Erectile Dysfunction, run by Biozeus Biopharmaceutical S.A. at 1 site in Brazil.
Trial summary
To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction, Prostate Cancer
- What is being tested?
- Tadalafil 5mg and BZ371A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Nov 2023to 31 Jan 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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;
- Histroy of priapism, defined as painful erection from up to 6 hours.
- 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;
- Known hypersensitivity to tadalafil and/or BZ371A;
- History of symptomatic Lactose intolorence such as: the necessity of enzymatic treatment, abdominal distension or diarrhea when ingesting products or supplements with lactose;
- Low adhsesion to 5mg Tadalafil use, characterized by the use of <80% of the pills between the 30th and 60th day post PR;.
- Pregnant or lacting partner.
- Partner in childbearing age which does not accept to get exposed to the treatment
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Urológica
Belo Horizonte
Luiz Otávio Torres, Dr., 3190737299, contatoestudo2023@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction, Prostate Cancer, Radical Prostatectomy
- Being tested
- Tadalafil 5mg, BZ371A, Oral Placebo, Topical Placebo
- Keywords
- Erectile Dysfunction, Radical Prostatectomy, Prostate Cancer
- Medical subject headings
- Erectile Dysfunction, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mgDrug
Also called Tadalafil
Daily oral administration of tadalafil 5mg
BZ371ADrug
Topical application of 1.5 mL of BZ371A in a concentration of 5mg/mL
Oral PlaceboDrug
Oral administration of a placebo pill
Topical PlaceboDrug
Topical application of 1.5 mL of placebo
| Study group | Role | What they receive |
|---|---|---|
| Daily oral Tadalafil 5mg + Topical Placebo | Active comparator | Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical placebo Receives: 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 Receives: 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 Receives: Drug: Tadalafil 5mg; Drug: BZ371A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From up to 30 days before Baseline, Baseline, 30 days, 60 days
Secondary outcomes (12)
Change in successful vaginal intercourse rate
Rate of successful vaginal intercourse will be assessed through question 3 of the SEP (Sexual Encouter Profile) questionnaire.
Measured: From up to 30 days before Baseline, Baseline, 30 days, 60 days
Change in quality of sexual intercourse
Quality of sexual intercourse, through the EDITS questionnaire (Erectile Dysfunction Inventory of Treatment Satisfaction);
Measured: 30 days, 60 days
Change in penile extension
Penile extension, measured with a ruler.
Measured: Baseline, 30 days, 60 days
Penile Blood flow increase
Increased blood flow, assessed by peak systolic velocity (PSV), end-diastolic velocity (EDV) and resistivity index (RI) assessed by Doppler examination;
Measured: From up to 30 days before Baseline, Baseline, 30 days, 60 days
Adverse effects report
Adverse effects evaluation of compound use and application
Measured: Baseline 30 days, 60 days and 75 days
Physical examination of the applied region
Number of participants with abnormal physical exam findings in the applied region
Measured: From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days
Change in SBP
Change in Systolic Blood Pressure
Measured: From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days
Change in DBP
Change in Diastolic Blood Pressure
Measured: From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days
Change in Heart Rate (HR)
Change in Heart Rate
Measured: From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days
Basal chest electrocardiogram (ECG).
Number of participants with abnormal ECG test results
Measured: From up to 30 days before Baseline, 30 days and 60 days
Blood evaluation
Number of participants with abnormal laboratory test results
Measured: From up to 30 days before Baseline, and 60 days
Urine evaluation
Number of participants with abnormal laboratory test results
Measured: From up to 30 days before Baseline, and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start22 Nov 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biozeus Biopharmaceutical S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luiz Otávio Torres, Dr, Principal investigator, Hospital Urológica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558007
- Sponsor's protocol ID
- BZ371CLI004
- Status last verified
- Oct 2024
- First submitted
- 22 Sep 2022
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No