Actively Recruiting
Phase 2 Clinical Trial to Evaluate Safety and Efficacy of Topical BZ371A Gel with Daily Tadalafil in Men After Radical Prostatectomy
Led by Biozeus Biopharmaceutical S.A. · Updated on 2024-10-22
72
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of a topical gel called BZ371A in men who have undergone Radical Prostatectomy (RP) due to prostate cancer. RP is a common treatment for prostate cancer but can damage nerves that control blood flow to the penis, leading to erectile dysfunction. This study aims to support recovery of erectile function in these patients by assessing BZ371A combined with daily oral tadalafil or compared to placebo. The study includes three groups: one receiving daily oral tadalafil with a topical placebo, another receiving daily oral placebo with topical BZ371A, and a third group receiving both daily oral tadalafil and topical BZ371A. The topical gel is applied in a 1.5 mL dose with a concentration of 5 mg/mL. Treatments are administered over a period starting shortly after surgery, with patients using the treatments daily and followed for up to 75 days post-baseline. Participants will undergo assessments including erectile function questionnaires, vaginal intercourse success rates, sexual quality evaluations, and measurements of penile extension and blood flow at various points throughout the study. Safety will be monitored through physical exams, blood pressure, heart rate, ECGs, blood and urine tests, and adverse event reports. The primary outcome is the change in assisted erectile function measured from before baseline through 60 days after treatment, with continued monitoring until 75 days after baseline.
CONDITIONS
Brief Title
Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 40 to 65 years
- Heterosexual men of any race or social class
- Underwent Radical Prostatectomy for prostate cancer without metastasis
- Surgery performed less than 60 days before screening
- Normal erectile function before surgery (IIEF score above 22 in domain A)
- Stable sexual partner for more than 2 months before surgery and intent to continue the relationship
- Continuous use of 5 mg Tadalafil daily from day 30 to day 60 after surgery
You will not qualify if you...
- Prostate cancer at stage T3 or T4
- Perineal or open Radical Prostatectomy
- Need for other prostate cancer treatments besides surgery, such as radiation or hormone therapy
- Uncontrolled diabetes with HbA1C over 10%
- Prior spinal cord injury causing lower limb paralysis
- Current use of male hormones or hypogonadism with low testosterone levels
- Current depression requiring antidepressants
- Genital lesions or active sexually transmitted diseases that affect genital evaluation
- Use of topical genital medications that interfere with study treatments
- Presence of penile prosthesis
- History of symptomatic hypotension or heart and kidney diseases increasing hypotension risk
- Current use of nitrates or specific medications like ketoconazole, ritonavir, or rifampicin
- Abnormal ECG or lab results posing risk to participation
- Blood pressure outside safe limits (SBP <90 or >170 mmHg; DBP <50 or >100 mmHg)
- Diseases causing priapism or history of prolonged painful erections
- Ongoing diarrhea lasting more than four weeks with associated symptoms
- Known allergy to tadalafil or BZ371A
- History of symptomatic lactose intolerance
- Poor adherence to tadalafil treatment
- Partner who is pregnant, lactating, or of childbearing age unwilling to avoid exposure
- Any significant illness or condition that increases risk or interferes with study results, including severe mental illness or other cancers besides prostate cancer
- Persistent medication abuse or severe debilitating illness limiting participation or safety
- Patient's partner must not be pregnant or breastfeeding and must agree to treatment exposure risks as applicable to childbearing age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days
Participants receive daily oral tadalafil 5mg and/or topical BZ371A or placebos to evaluate recovery of erectile function after Radical Prostatectomy.
Baseline visit and follow-up visits at 30 and 60 days
Duration - Up to 15 days after treatment
Participants are monitored for safety and tolerability after treatment ends, including physical exams and adverse effect assessments.
Visits at 60 and 75 days
Trial Site Locations
Total: 1 location
1
Hospital Urológica
Belo Horizonte, Brazil
Actively Recruiting
Research Team
C
Camilla NR Trindade, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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