Clinical Efficacy of Intracavernosal Xeomin as an Adjunctive Therapy to on Demand Tadalafil 20 mg for the Treatment of Mild to Moderate Erectile Dysfunction: A Randomized Crossover Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Change in erectile function
研究概览
简要总结
Erectile dysfunction (ED) affects approximately 30 million men in the United States and is associated with factors such as aging, smoking, diabetes, hypertension, obesity, and sedentary lifestyle. ED can also negatively impact the quality of life of patients and their partners. Treatment decisions are typically made jointly between patients and their urologists, often starting with less invasive options. Oral phosphodiesterase-5 inhibitors (PDE5 inhibitors), including sildenafil, tadalafil, and vardenafil, are commonly used as first-line therapy. While these medications improve erectile function in many patients, approximately 30-40% do not respond adequately to PDE5 inhibitor therapy alone. Patients who do not achieve sufficient benefit may require additional or more invasive treatment options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from the subject
- •History of ED for at least 6 months prior to screening, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" (NIH), the diagnosis of ED has to be confirmed by a physician
- •Understanding of study procedures and willingness to abide by all procedures during the course of the study
- •Male subject aged ≥18 to ≤ 80 years at visit 1
- •Have a monogamous relationship with a female sexual partner (vaginal penetration required for several of the primary efficacy variables) for at least 6 months prior to screening
- •Highly motivated to obtain treatment for ED
- •History of previous use of at least 1 marketed PDE5 inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose
排除标准
- •Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type A) or to any of the excipients (Human albumin, sucrose)
- •BW <50 kg
- •Diagnosis of spinal cord injury
- •ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease (e.g., hypopituitarism, hypothyroidism, or hypogonadism)
- •History of penile implant.
- •The presence of clinically significant penile deformity in the opinion of the investigator.
- •Concomitant diagnosis of Peyronie's disease
- •Patients with chronic stable angina treated with long-acting nitrates, or patients with chronic stable angina who have required short-acting nitrates in the last 90 days, or angina occurring during sexual intercourse in the last 6 months.
- •Patients having met the criteria for unstable angina within 6 months prior to Visit 1, history of myocardial infarction or coronary artery bypass graft surgery within 90 days prior to Visit 1, or percutaneous coronary intervention (e.g., angioplasty or stent placement) within 90 days prior to Visit
- •Any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 bpm) at rest despite medical or device therapy, or any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for 30 sec) despite medical or device therapy, or the presence of an automatic internal cardioverter-defibrillator.
- •A history of sudden cardiac death (arrest) despite medical or device therapy.
- •Any evidence of congestive heart failure within 6 months prior to Visit
- •A significant conduction defect within 90 days prior to Visit
- •Systolic blood pressure >170 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at screening (if stress is suspected, retest under basal conditions), or patients with malignant hypertension.
- •<12 weeks since most recent injection of BTX-A/B into any body region for any indication
- •Neurological disorder associated with neuro muscular dysfunction of any kind in medical history.
- •Planned concomitant treatment with BTX -A/B of any body region during the study.
- •Known hypersensitivity to human serum albumin, sucrose, or the active substance BTX-A.
- •Generalized disorders of muscles activity (e.g. myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study.
- •Any condition that would interfere with the patient's ability to provide informed consent or comply with study instructions, would place patient at increased risk, or might confound the interpretation of the study results.
- •Current treatment with nitrates (as outlined in previous Exclusion Criterion, cancer chemotherapy, or anti-androgens.
- •History of drug, alcohol, or substance abuse within the past 6 months.
- •Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- •Treatment within the last 30 days with a drug or device that has not received regulatory approval at the time of study entry.
- •Ongoing severe or uncontrolled systemic disease, current malignancy, hemophilia, or HIV infection in medical history.
- •Severe or uncontrolled respiratory disease in medical history.
- •Evidence or suspicion that the subject is not willing or unable (e.g. Due to severe cognitive communication impairment) to understand the information that is given to him as part of the informed consent, in particular regarding the risks and discomfort which he would agree to be exposed to.
- •Any reason which in the investigator's opinion is likely to compromise the subject's ability to participate in the study.
- •Subject who is imprisoned or is lawfully kept in an institution
- •Participation in a clinical study within 12 weeks prior to screening or planned participation during this study.
- •Previous participation in this clinical study.
研究组 & 干预措施
Xeomin + PDE5i
Subjects in this portion of the trial will be administered 20 mg of Tadalafil in conjunction with 100 units of Xeomin
干预措施: Tadalafil 20 MG (Drug)
Xeomin + PDE5i
Subjects in this portion of the trial will be administered 20 mg of Tadalafil in conjunction with 100 units of Xeomin
干预措施: IncobotulinumtoxinA (100 Units) (Drug)
Placebo + PDE5i
Subjects in this portion of the trial will be administered 20 mg of Tadalafil in conjunction with a placebo
干预措施: Placebo (Other)
Placebo + PDE5i
Subjects in this portion of the trial will be administered 20 mg of Tadalafil in conjunction with a placebo
干预措施: Tadalafil 20 MG (Drug)
结局指标
主要结局
Change in erectile function
时间窗: 3-6 months
Change in erectile function as measured by the validated IIEF-EF domain (3-6 months) following Xeomin portion of the crossover study. This domain provides a score on a scale of 6-30, where scores can be interpreted as follows: * 26-30: No Erectile Dysfunction * 22-25: Mild Erectile Dysfunction * 17-21: Mild to Moderate Erectile Dysfunction * 11-16: Moderate Erectile Dysfunction * 6-10: Severe Erectile Dysfunction
Change in erectile hardness
时间窗: 3-6 months
Change in erectile hardness as measured by the validated erectile hardness scale (EHS) (3-6 months) following Xeomin portion of the crossover study. The scale ranges from Grade 0 - Grade 4. It measures the firmness of an erection using the following grade interpretation: * Grade 0: Penis does not enlarge. * Grade 1: Penis is larger, but not hard. * Grade 2: Penis is hard, but not hard enough for penetration. * Grade 3: Penis is hard enough for penetration, but not completely hard. * Grade 4: Penis is completely hard and fully rigid
次要结局
- Persistence of efficacy in erectile hardness(3-6 months)
- Persistence of efficacy in erectile function(3-6 months)
研究者
Nelson Bennett
Professor
Northwestern University