Phase 2 Clinical Trial to Evaluate Safety and Efficacy of BZ371A in a Gel Applied in Patients That Performed Radical Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Assisted Erectile Function
研究概览
简要总结
To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Prostate cancer in TNM stage classified as T3 or T
- •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;
- •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;
研究组 & 干预措施
Daily oral Tadalafil 5mg + Topical Placebo
Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical placebo
干预措施: Tadalafil 5mg (Drug)
Daily oral Tadalafil 5mg + Topical Placebo
Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical placebo
干预措施: Topical Placebo (Drug)
Daily oral placebo + topical BZ371A
Patient that underwent Radical Prostatectomy will receive daily oral placebo and topical BZ371A
干预措施: BZ371A (Drug)
Daily oral placebo + topical BZ371A
Patient that underwent Radical Prostatectomy will receive daily oral placebo and topical BZ371A
干预措施: Oral Placebo (Drug)
Daily oral Tadalafil 5mg + topical BZ371A
Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical BZ371A
干预措施: Tadalafil 5mg (Drug)
Daily oral Tadalafil 5mg + topical BZ371A
Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical BZ371A
干预措施: BZ371A (Drug)
结局指标
主要结局
Change in Assisted Erectile Function
时间窗: 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).
次要结局
- Change in penile extension(Baseline, 30 days, 60 days)
- 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)
- Physical examination of the applied region(From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days)
- Change in DBP(From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days)
- Change in Heart Rate (HR)(From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days)
- Basal chest electrocardiogram (ECG).(From up to 30 days before Baseline, 30 days and 60 days)
- Blood evaluation(From up to 30 days before Baseline, and 60 days)
- Adverse effects report(Baseline 30 days, 60 days and 75 days)
- Change in SBP(From up to 30 days before Baseline, Baseline, 30 days, 60 days and 75 days)
- Penile Blood flow increase(From up to 30 days before Baseline, Baseline, 30 days, 60 days)
- Urine evaluation(From up to 30 days before Baseline, and 60 days)